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Archive for the ‘Regenerative Medicine’ Category

BioTime CEO Michael D. West to Present at 2012 Maxim Group Growth Conference

Friday, March 23rd, 2012

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer, Michael D. West, Ph.D., will present a corporate overview of BioTime and its subsidiaries with an update on recent developments at the 2012 Maxim Group Growth Conference on Monday, March 26, 2012, 11:00 a.m. EDT, at the Grand Hyatt in New York City. The presentation will be webcast and available online at the Investors section of the BioTime website at http://www.biotimeinc.com.

The 5th annual Maxim Group Growth Conference is designed to provide institutional clients with the opportunity to gain an in-depth perspective on the issues affecting the growth of presenting companies. The one-day event will feature more than 80 company presentations across six designated industry tracks including the healthcare and biotechnology sectors.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media, and differentiation kits. BioTime's wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure's OpRegen retinal cell product for use in the treatment of age-related macular degeneration. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-DxTM currently being developed for the detection of cancer in blood samples, therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime's research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low-temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://phx.corporate-ir.net/phoenix.zhtml?c=83805&p=irol-alerts

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BioTime CEO Michael D. West to Present at 2012 Maxim Group Growth Conference

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Cosmetic Regenerative Medicine – Video

Thursday, March 15th, 2012

13-03-2012 16:42 Hear Dr. Bowen talk about the exciting field of Regenerative Medicine. The type of regenerative medicine Dr. Bowen practices uses our own adult stem cells to achieve desired results.

Continue reading here:
Cosmetic Regenerative Medicine - Video

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

Thursday, March 15th, 2012

SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science.

"We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field."

The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance.

Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

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Millipore and Toronto non-profit cultivate stem cells in bioreactor

Monday, March 12th, 2012

Robert Shaw, left, commercial director of EMD Millipores Stem Cell Initiative, and Michael May, CEO of the Centre for Commercialization of Regenerative Medicine in Toronto.

EMD Millipore, the Billerica-based life science division of Merck KGaA, said today that it is collaborating with the Centre for Commercialization of Regenerative Medicine in Toronto to develop optimized conditions to cultivate stem cells in a bioreactor.

The two parties will focus on developing a proprietary monitoring and control methodology for robust growth of adherent human pluripotent stem cells in EMD Millipores Mobius CellReady stirred tank bioreactor. The aim is to produce a commercial kit with reagents and associated methodologies for bioreactor culture of stem cells on microcarriers. No value was given for the collaboration.

As the demand for stem cells used in drug discovery and clinical applications grows, effectively translating the promise of stem cells into therapeutic reality will require large-scale, industrialized production under tightly controlled conditions, Robert Shaw, commercial director of EMD Millipores Stem Cell Initiative, said in a statement. He added that current production uses stacks of 2D tissue culture vessels, an expensive and labor-intensive process. The joint project is tackling those challenges, with the goal of large-scale cultivation of stem cells. Shaw said that may accelerate the progress of therapies into the clinic.

EMD Millipore is the first project partner of the regenerative medicine center, said Michael May, CEO of the center, which is using Millipores bioreactor in its product development facility at the University of Torontos Banting Institute. The work began on Feb. 27, 2012.

EMD Millipore has about 10,000 employees, operations in 67 countries and 2010 revenues of $2.2 billion. The company is known as Merck Millipore outside of the United States and Canada.

The regenerative medicine center is a Canadian non-profit organization funded by the Government of Canadas Networks of Centres of Excellence program and six institutional partners. It supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based products. The center launched in Torontos Discovery District on June 14, 2011.

Just two weeks ago Charles River Laboratories International Inc. (NYSE: CRL) of Wilmington signed an exclusive license for EMD Millipores TrueSpike technology under which the two will collaborate to integrate TrueSpike into Charles Rivers viral clearance services that aim to improve drug product safety.

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Millipore and Toronto non-profit cultivate stem cells in bioreactor

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Biostem U.S., Corporation Appoints Heart Surgeon, Thomas W. Prendergast, M.D. to Its Scientific and Medical Board of …

Monday, March 12th, 2012

CLEARWATER, FL--(Marketwire -03/12/12)- Biostem U.S., Corporation (OTCQB: BOSM.PK - News) (Pinksheets: BOSM.PK - News) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announced today the addition of cardiothoracic surgeon Thomas W. Prendergast, M.D. to its Scientific and Medical Board of Advisors (SAMBA).

Biostem CEO, Dwight Brunoehler stated, "The Company is now positioned for growth and international expansion. Adding a world class team of clinical, laboratory, and regulatory experts for our Scientific and Medical Board of Advisors to guide our pursuits is essential. Dr. Prendergast brings a wealth of experience not only in the scientific aspects of stem cell use in regenerative medicine, but also in forging research and international economic development opportunities."

Dr. Prendergast is a busy clinical cardiothoracic surgeon, who performs 200-250 open-heart operations and 5 to 15 heart transplants each year. He is deeply involved in numerous clinical and research activities associated with stem cells and heart repair. He is presently Director of Cardiac Transplantation at Robert Wood Johnson University Hospital in New Brunswick, New Jersey where he holds an Associate Professorship of Surgery at the University of Medicine and Dentistry of New Jersey. In addition to being an active participant in stem cell research program development and teaching medical students and residents, his other interests include medical research funding and humanitarian development of programs for Disabled American Veterans.

Dr. Prendergast received his undergraduate degrees in biophysics and Psychology, as well as his medical degree, at Pennsylvania State University. His general surgery residency was for five years at the University of Massachusetts Medical School. His cardiothoracic surgery training was at the University of Southern California School of Medicine, including the Los Angeles County Medical Center. Subsequent fellowship training included pediatric cardiac surgery at Children's Hospital of LA, along with thoracic transplant fellowships at University of Southern California in Los Angeles and at Temple University Hospital in Philadelphia. He spent three years at the University of Kansas establishing thoracic transplant programs until returning to Temple University Hospital as one of their staff heart and lung transplant surgeons. Subsequent to his time at Temple, he joined up with Newark Beth Israel/St. Barnabas Hospitals, where he assumed directorship as the Chief of Cardiac Transplantation and Mechanical Assistance.

Regarding his appointment to the Biostem U.S. Scientific and Medical Board of Advisors, Dr. Prendergast said, "I am looking forward with excitement to working again with Dwight at Biostem. The expansion plan is sound, well paced, and will afford improved quality of life opportunities to many people around the world."

About Biostem U.S., Corporation

Biostem U.S., Corporation (OTCQB: BOSM.PK - News) (Pinksheets: BOSM.PK - News) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered around providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Kerry D'Amato, Marketing Director at 727-446-5000.

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Biostem U.S., Corporation Appoints Heart Surgeon, Thomas W. Prendergast, M.D. to Its Scientific and Medical Board of ...

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EMD Millipore and the Centre for Commercialization of Regenerative Medicine Collaborate to Optimize Conditions for …

Monday, March 12th, 2012

BILLERICA, MASSACHUSETTS and TORONTO, ONTARIO--(Marketwire -03/12/12)- Editors Note: There is a photo associated with this press release.

EMD Millipore, the Life Science division of Merck KGaA, and the Centre for Commercialization of Regenerative Medicine (CCRM) today announced a collaboration to develop optimized conditions for bioreactor-based cultivation of stem cells.

This joint project will focus on the development of a proprietary monitoring and control methodology, enabling robust growth of adherent human pluripotent stem cells in EMD Millipore's Mobius CellReady stirred tank bioreactor. Ultimately, the project will deliver a commercially available kit containing reagents and associated methodologies for bioreactor culture of stem cells on microcarriers.

"As the demand for stem cells used in drug discovery and clinical applications grows, effectively translating the promise of stem cells into therapeutic reality will require large-scale, industrialized production under tightly controlled conditions," states Robert Shaw, Commercial Director of EMD Millipore's Stem Cell Initiative. "At this time, production is typically achieved using stacks of 2D tissue culture vessels, which is an expensive and labor intensive process. This joint project will address those challenges and facilitate optimized, large-scale cultivation of stem cells which can accelerate the progress of therapies into the clinic."

"When CCRM was created, we had industry partnerships like this in mind," says Michael May, CEO of the Centre for Commercialization of Regenerative Medicine. "We are delighted to have EMD Millipore as our first project partner. Their production expertise and technologies will help CCRM to develop products that will benefit industry, academia, and the patient community. We appreciate that EMD Millipore has commissioned us to undertake this project and recognizes our strength in bioprocessing engineering."

CCRM will be employing EMD Millipore's Mobius CellReady stirred tank bioreactor in its product development facility at the University of Toronto's Banting Institute. The work began on February 27, 2012.

For more information, please visit http://www.millipore.com and http://www.ccrm.ca.

About EMD Millipore

EMD Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers' success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, EMD Millipore serves as a strategic partner to customers and helps advance the promise of life science.

Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 67 countries and 2010 revenues of $2.2 billion. EMD Millipore is known as Merck Millipore outside of the U.S. and Canada.

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EMD Millipore and the Centre for Commercialization of Regenerative Medicine Collaborate to Optimize Conditions for ...

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Predicting the Success of the Late-Stage Cell-Based Cancer Immunotherapy Pipeline?

Sunday, March 11th, 2012

Tweet 


Adam
Feuerstein
(phama and biotech writer with TheStreet.com) has designed his own rule. 

For those who know or follow Adam, this will come as no surprise.  He is
neither short of rules nor opinion and is never shy in his vivid expression of
either.  But this rule is more than a simple expression of informed
opinion. It was born of hard data analysis and has yet to be broken.  In
Adam’s own words, this is how he and his colleague (Mark J. Ratain) came to the
rule they coined the Feuerstein-Ratain Rule:
[We] analyzed the outcomes of
59 phase III clinical trials of cancer drugs going back 10 years, stratified by
the market value of the companies four months prior to trial results being
announced. What we found was a remarkable difference between the market values of companies that had positive and negative
announcements
.  (the list of companies/products used can be found here
)
Specifically, the median market capitalization was approximately
80-fold greater for the companies with positive trials vs. companies with
negative trials. There were no positive trials among the 21 micro-cap companies
(companies with less than $300 million market capitalization) whereas 21 of 27
studies reported by the larger companies analyzed (greater than $1 billion
capitalization) were positive.
Here’s the rule in a nutshell: 
There is a 100% failure rate for phase III cancer
drug trials conducted by micro-cap cancer drug developers
.
The
editorial, entitled “Oncology Micro-Cap Stocks: Caveat Emptor!”, can be
found in Journal of the National Cancer
Institute
 
(JNCI) at http://jnci.oxfordjournals.org/content/early/2011/09/26/jnci.djr375.full.
They identified
drugs that were undergoing evaluation in phase III trials or for regulatory approval
by the US FDA between January 2000 and January 2009. 
They calculated the
company value based on the market value of primary drug sponsor roughly
three months prior to the release of the data.  They concluded that
whether or not a company had pharma in place was not determinative of a drug’s
success but rather that partnerships or acquisitions by Big Pharma can play a
role in determining a drug’s success only in that these deals may increase the
market value of the primary drug sponsor.  That value was the
determinative factor.
This
is Adam’s summary of the analysis they did that led to the “Feuerstein-Ratain Rule”.  
Below
are the important snippets from the analysis behind the rule:
The "Feuerstein-Ratain
rule" is derived from an analysis of 59 phase III clinical trials of
cancer drugs conducted over the past 10 years. We actually had no say
whatsoever in the selection of cancer drugs used in the analysis. The list was
put together by health economist Allan Detsky of Toronto's Mount Sinai Hospital
and his co-authors as part of their paper published in the Journal of the National Cancer
Institute
 suggesting that
doctors entrusted with conducting late-stage cancer drug clinical trials are
using advanced knowledge of the results of these pivotal studies to engage in
illegal insider trading.
Ratain and I used the same list of 59 cancer drug clinical trials,
re-analyzed by market value of the drug sponsors, to debunk Detsky's
insider-trading theory. That's how the "Feuerstein-Ratain rule" came
about, and we published our conclusions in the JNCI alongside Detsky's paper.
To restate our findings:  No positive trials among the
21 micro-cap companies
(companies with less than $300 million market
capitalization) whereas 21 of 27 studies reported by the larger companies analyzed
(greater than $1 billion capitalization) were positive
There were 21 companies on the
list with market values of $300 million or less, with a 0% success rate in
phase III cancer drug clinical trials.
The list also contained 11 companies with market caps between
$300 million and $1 billion. The clinical trial success rate for this mid-tier
or second strata group was 18%. (Two positive clinical trials out of 11.)
Lastly, there were 21 of 27 studies reported by the larger
companies analyzed (greater than $1 billion capitalization) that were positive,
or a 78% success rate.
So
what interesting for us in cell therapy?
It
is interesting to note that the Feuerstein-Ratain Rule is
limited to oncology drugs and all the companies behind them were public. 
Adam has not – nor has anyone else to the best of my knowledge – looked at how
the rule may or may not translate outside of oncology.

Of
the cell therapy companies to have received market approval in US or EU in the
past 10 years, one was public (DNDN) and one was still private (TIG) and went
public shortly therafter in the same year. TiGenix was a private company and is
not in oncology so the analysis arguably does not apply.  However,
Dendreon’s Provenge is an oncology ‘drug’.  Dendreon had a market cap of
about $430M in the 4 months before its ph III data was announced and as such
would have fallen in the 18% likelihood of success category.  That sounds
about right.

I thought it might be interesting to do our own look at what the Rule might say about the pipeline of late-stage cell-based oncology trials.  Following
is a list of cell therapy companies currently in ph III or II/III for oncology:

2010 Onco CT Immunotherapies (late-stage)
* Trial not expected to complete until Q1
2014 so a lot could happen to the market cap in 2012/13.  It also could be
argued that this is not an oncology treatment as per original data set but a
treatment of the side  effects of the primary cancer treatment.
** Trial not expected to complete until Q1
2014 so a lot could happen to the market cap in 2012/13.
*** It could be argued that this is not an
oncology treatment as per original data set but 
a treatment of the side effects of the primary cancer treatment.
+ It could be argued this is not a cell
therapy though we would argue it is.  Others might argue that as a phase II/III
trial with only 60 patients this may not be powered to be a pivotal oncology trial.
^ Trial currently in “suspension” so this
date may be pushed out or trial terminated. It also could be argued that this
is not an oncology treatment as per original data set but a treatment of
the effects of the primary cancer treatment.  Others might argue that as a phase II/III trial with
only 70 patients this may not be powered to be a pivotal oncology trial.
Conclusion:  At the moment it looks like both NovaRx and ERYtech will go to their phase III data completion (June and October 2012 respectively) as private companies.  To qualify under the rule, Cell Medica would have to go public within the year and/or Kiadis would have to go public within the next 25 months. 

The only
companies with cell-based oncology products currently in late-stage trials to
which the Rule would apply are Molmed’s HSV-TK and Newlink Genetics’ HyperAcute
Pancreas.  

Assuming both MolMed and NewLink's trials progress as planned, we won’t know what
they look like under the rule until around Sept 2013 at which time we can assess their
market cap against the Rule.  At the moment, it’s looking pretty bleak for
both of them according to the Rule though at least the NLNK price has been
going in the right direction of late.  

Certainly one would expect trading
volume to dramatically increase on both these as their trial completion dates
near.  It remains to be seen how this will impact price but they would
have to  dramatically increase in market cap (double or triple) to succeed
as the Rule predicts. 

Naturally, this is just one way of looking at the world and, of course, this rule - as with all rules - is meant to be broken.
  

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

Source:
http://feeds.feedburner.com/CellTherapyBlog

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Predicting the Success of the Late-Stage Cell-Based Cancer Immunotherapy Pipeline?

Sunday, March 11th, 2012

Tweet 


Adam
Feuerstein
(phama and biotech writer with TheStreet.com) has designed his own rule. 

For those who know or follow Adam, this will come as no surprise.  He is
neither short of rules nor opinion and is never shy in his vivid expression of
either.  But this rule is more than a simple expression of informed
opinion. It was born of hard data analysis and has yet to be broken.  In
Adam’s own words, this is how he and his colleague (Mark J. Ratain) came to the
rule they coined the Feuerstein-Ratain Rule:
[We] analyzed the outcomes of
59 phase III clinical trials of cancer drugs going back 10 years, stratified by
the market value of the companies four months prior to trial results being
announced. What we found was a remarkable difference between the market values of companies that had positive and negative
announcements
.  (the list of companies/products used can be found here
)
Specifically, the median market capitalization was approximately
80-fold greater for the companies with positive trials vs. companies with
negative trials. There were no positive trials among the 21 micro-cap companies
(companies with less than $300 million market capitalization) whereas 21 of 27
studies reported by the larger companies analyzed (greater than $1 billion
capitalization) were positive.
Here’s the rule in a nutshell: 
There is a 100% failure rate for phase III cancer
drug trials conducted by micro-cap cancer drug developers
.
The
editorial, entitled “Oncology Micro-Cap Stocks: Caveat Emptor!”, can be
found in Journal of the National Cancer
Institute
 
(JNCI) at http://jnci.oxfordjournals.org/content/early/2011/09/26/jnci.djr375.full.
They identified
drugs that were undergoing evaluation in phase III trials or for regulatory approval
by the US FDA between January 2000 and January 2009. 
They calculated the
company value based on the market value of primary drug sponsor roughly
three months prior to the release of the data.  They concluded that
whether or not a company had pharma in place was not determinative of a drug’s
success but rather that partnerships or acquisitions by Big Pharma can play a
role in determining a drug’s success only in that these deals may increase the
market value of the primary drug sponsor.  That value was the
determinative factor.
This
is Adam’s summary of the analysis they did that led to the “Feuerstein-Ratain Rule”.  
Below
are the important snippets from the analysis behind the rule:
The "Feuerstein-Ratain
rule" is derived from an analysis of 59 phase III clinical trials of
cancer drugs conducted over the past 10 years. We actually had no say
whatsoever in the selection of cancer drugs used in the analysis. The list was
put together by health economist Allan Detsky of Toronto's Mount Sinai Hospital
and his co-authors as part of their paper published in the Journal of the National Cancer
Institute
 suggesting that
doctors entrusted with conducting late-stage cancer drug clinical trials are
using advanced knowledge of the results of these pivotal studies to engage in
illegal insider trading.
Ratain and I used the same list of 59 cancer drug clinical trials,
re-analyzed by market value of the drug sponsors, to debunk Detsky's
insider-trading theory. That's how the "Feuerstein-Ratain rule" came
about, and we published our conclusions in the JNCI alongside Detsky's paper.
To restate our findings:  No positive trials among the
21 micro-cap companies
(companies with less than $300 million market
capitalization) whereas 21 of 27 studies reported by the larger companies analyzed
(greater than $1 billion capitalization) were positive
There were 21 companies on the
list with market values of $300 million or less, with a 0% success rate in
phase III cancer drug clinical trials.
The list also contained 11 companies with market caps between
$300 million and $1 billion. The clinical trial success rate for this mid-tier
or second strata group was 18%. (Two positive clinical trials out of 11.)
Lastly, there were 21 of 27 studies reported by the larger
companies analyzed (greater than $1 billion capitalization) that were positive,
or a 78% success rate.
So
what interesting for us in cell therapy?
It
is interesting to note that the Feuerstein-Ratain Rule is
limited to oncology drugs and all the companies behind them were public. 
Adam has not – nor has anyone else to the best of my knowledge – looked at how
the rule may or may not translate outside of oncology.

Of
the cell therapy companies to have received market approval in US or EU in the
past 10 years, one was public (DNDN) and one was still private (TIG) and went
public shortly therafter in the same year. TiGenix was a private company and is
not in oncology so the analysis arguably does not apply.  However,
Dendreon’s Provenge is an oncology ‘drug’.  Dendreon had a market cap of
about $430M in the 4 months before its ph III data was announced and as such
would have fallen in the 18% likelihood of success category.  That sounds
about right.

I thought it might be interesting to do our own look at what the Rule might say about the pipeline of late-stage cell-based oncology trials.  Following
is a list of cell therapy companies currently in ph III or II/III for oncology:

2010 Onco CT Immunotherapies (late-stage)
* Trial not expected to complete until Q1
2014 so a lot could happen to the market cap in 2012/13.  It also could be
argued that this is not an oncology treatment as per original data set but a
treatment of the side  effects of the primary cancer treatment.
** Trial not expected to complete until Q1
2014 so a lot could happen to the market cap in 2012/13.
*** It could be argued that this is not an
oncology treatment as per original data set but 
a treatment of the side effects of the primary cancer treatment.
+ It could be argued this is not a cell
therapy though we would argue it is.  Others might argue that as a phase II/III
trial with only 60 patients this may not be powered to be a pivotal oncology trial.
^ Trial currently in “suspension” so this
date may be pushed out or trial terminated. It also could be argued that this
is not an oncology treatment as per original data set but a treatment of
the effects of the primary cancer treatment.  Others might argue that as a phase II/III trial with
only 70 patients this may not be powered to be a pivotal oncology trial.
Conclusion:  At the moment it looks like both NovaRx and ERYtech will go to their phase III data completion (June and October 2012 respectively) as private companies.  To qualify under the rule, Cell Medica would have to go public within the year and/or Kiadis would have to go public within the next 25 months. 

The only
companies with cell-based oncology products currently in late-stage trials to
which the Rule would apply are Molmed’s HSV-TK and Newlink Genetics’ HyperAcute
Pancreas.  

Assuming both MolMed and NewLink's trials progress as planned, we won’t know what
they look like under the rule until around Sept 2013 at which time we can assess their
market cap against the Rule.  At the moment, it’s looking pretty bleak for
both of them according to the Rule though at least the NLNK price has been
going in the right direction of late.  

Certainly one would expect trading
volume to dramatically increase on both these as their trial completion dates
near.  It remains to be seen how this will impact price but they would
have to  dramatically increase in market cap (double or triple) to succeed
as the Rule predicts. 

Naturally, this is just one way of looking at the world and, of course, this rule - as with all rules - is meant to be broken.
  

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New Industry Partnership to Strengthen Regenerative Medicine Industry in Canada

Friday, March 9th, 2012

TORONTO, ONTARIO--(Marketwire -03/09/12)- The newest player in the regenerative medicine (RM) field in Canada is taking a collaborative approach to commercializing stem cell and biomaterials products. The Centre for Commercialization of Regenerative Medicine (CCRM) has created an industry consortium that is working together to address real-life bottlenecks in their RM product pipelines.

CCRM's scientific leadership is recognized by the global RM community as being world-leading. According to Michael May, CEO of CCRM, partnering with industry completes the puzzle. "By working with industry, CCRM captures business expertise that informs product development and commercialization. We already had access to some of the best scientific minds in the field and now we have access to seasoned industry experts. This is key to our success and will accelerate product development."

The members of the industry consortium represent the key sectors of the RM industry: therapeutics, devices, reagents, and cells as tools. CCRM has built three core development platforms: reprogramming, cell manufacturing, and biomaterials and tissue mimetics. The intellectual property and infrastructure of CCRM's six research institution partners and support from 20 leading RM companies will enhance Canada's already strong leadership role in the RM field.

"CCRM is uniquely positioned to meet the needs of industry and academia," explains Greg Bonfiglio, Chair of CCRM's Board of Directors. "CCRM boasts scientific expertise and state-of-the-art resources in its development lab and this combination will benefit the regenerative medicine community that can capitalize on our ability to complete projects quickly and cost competitively."

The industry consortium members are as follows:

About the Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada's Networks of Centres of Excellence program and six academic partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM aims to translate scientific discoveries into marketable products for patients. CCRM launched in Toronto's Discovery District on June 14, 2011.

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BioTime to Present at ROTH 24th Annual Growth Stock Conference

Friday, March 9th, 2012

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Financial Officer, Peter S. Garcia, will present a corporate overview of BioTime and its subsidiaries at the ROTH 24th Annual Growth Stock Conference. The presentation will take place on Tuesday, March 13, 2012, at 9:30 a.m. PDT at The Ritz-Carlton Hotel in Dana Point, California. The presentation will be webcast and available online at the Investors section of the website at http://www.biotimeinc.com and at http://wsw.com/webcast/roth26/btx/.

ROTH Capital Partners will host more than 400 growth companies at its annual investment conference, March 11-14, 2012, including more than 130 healthcare companies in the biotechnology, healthcare services, medical device, and pharmaceutical sectors.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media, and differentiation kits. BioTime's wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure's OpRegen retinal cell product for use in the treatment of age-related macular degeneration. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-DxTM currently being developed for the detection of cancer in blood samples, therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime's research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low-temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list:

http://phx.corporate-ir.net/phoenix.zhtml?c=83805&p=irol-alerts

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Harvard Bioscience Comments on the Passing of Christopher Lyles

Wednesday, March 7th, 2012

HOLLISTON, Mass., March 6, 2012 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc. (Nasdaq:HBIO - News), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine is deeply saddened to learn of the passing of Mr. Christopher Lyles. Mr. Lyles was a recent recipient of a tracheal transplant regenerated in a Harvard Bioscience InBreath Bioreactor. Currently, we do not know the cause of Mr. Lyle's death. Our thoughts are with his family at this time. His family has released the following statement:

"We, the family of Christopher Lyles, sorrowfully inform you that Christopher passed away this morning, March 5, 2012. Christopher was a recipient and strong advocate of stem cell therapy. We do not want his journey to be in vain. We hope his bravery will pave the way for further research and development and acceptance of stem cell based therapies in the United States. We would like to thank everyone for their thoughts and prayers throughout Christopher's trailblazing journey."

About Harvard Bioscience

Harvard Bioscience ("HBIO") is a global developer, manufacturer and marketer of a broad range of specialized products, primarily apparatus and scientific instruments, used to advance life science research and regenerative medicine. We sell our products to thousands of researchers in over 100 countries primarily through our 850 page catalog (and various other specialty catalogs), our website, through distributors, including GE Healthcare, Thermo Fisher Scientific and VWR, and via our field sales organization. HBIO has sales and manufacturing operations in the United States, the United Kingdom, Sweden, Germany and Spain with additional facilities in France and Canada. For more information, please visit http://www.harvardbioscience.com.

The Harvard Bioscience, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6426

Forward-looking Statements

The statements made in this press release that are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by our use of such words as "will," "guidance," "objectives," "optimistic," "potential," "future," "expect," "plans," "estimates," "continue," "drive," "strategy," "crucial," "potential," "potentially," "growth," "long-term," "projects," "projected," "produce," "intends," "believes," "goals," "sees," "seek," "develop," "possible," "new," "enabling," "emerging," "opportunity," "pursue" and similar expressions that do not relate to historical matters. Forward-looking statements in this press release may include, but are not limited to, statements or inferences about the HBIO's or management's beliefs or expectations, the field of regenerative medicine, opportunities or potential opportunities in the field of regenerative medicine, HBIO's business strategy, the positioning of HBIO for growth, the market demand and opportunity for HBIO's current products or products it is developing or intends to develop, and HBIO's plans, objectives and intentions that are not historical facts.

These statements involve known and unknown risks, uncertainties and other factors that may cause HBIO's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Factors that may cause HBIO's actual results, performance or achievements to differ materially from those in the forward-looking statements include, but are not limited to, HBIO's failure to successfully expand its product offerings, introduce new products or commercialize new technologies, including in the field of regenerative medicine, decreased demand for the HBIO's products, including products in the field of regenerative medicine, due to changes in our customers' needs, our ability to obtain regulatory approvals, including FDA approval, for our products, including any products in the field of regenerative medicine, the current size or anticipated size of the regenerative medicine market, the existence and size of opportunities in the regenerative medicine market, our financial position, plus risk factors set forth under the heading "Item 1A. Risk Factors" in HBIO's Annual Report on Form 10-K for the fiscal year ended December 31, 2010 or described in HBIO's other public filings. HBIO's results may also be affected by factors of which HBIO is not currently aware. HBIO may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.

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Histogen Signs License Agreement with Suneva Medical for Cell Conditioned Media-based Aesthetic Products

Tuesday, March 6th, 2012

SAN DIEGO, March 5, 2012 /PRNewswire/ --Histogen Inc., a regenerative medicine company, and Suneva Medical, a privately-held aesthetics company, today announced that they have entered into a license agreement for physician-dispensed aesthetic products containing Histogen's proprietary multipotent cell conditioned media (CCM).

Under the terms of this license agreement, Suneva Medical has acquired exclusive U.S. licensing rights to Histogen's multipotent CCM and the ReGenica branded line of products for topical applications in the licensed market. Suneva Medical will manufacture the ReGenica product line and market it to aesthetic practitioners throughout the U.S. Histogen will receive a transfer price on the CCM, as well as royalties on future sales of ReGenica and product line extensions.

"First, let me say that, as the first step in expanding our business, we are very excited about this particular opportunity as the advent of regenerative medicine is upon us. One of our key business objectives is to find novel products that complement our rapidly growing dermal filler business. We believe Histogen's innovative technology coupled with our proven experience of developing and marketing aesthetic products is a winning combination as it enables us to offer our customers a differentiated product line," stated Nicholas Teti, Chairman and Chief Executive Officer of Suneva Medical.

Through Histogen's technology process, which mimics the embryonic environment including conditions of low oxygen and suspension, cells are triggered to become multipotent, and naturally produce proteins associated with skin renewal and scarless healing. The result is a soluble cell conditioned media containing cell-signaling proteins such as KGF, follistatin, stem cell factor, collagens and laminins, which support the epidermal stem cells that renew skin throughout life. In addition, factors associated with scarring, such as TGF-beta, are decreased or nonexistent.

"The applications for this proprietary multipotent CCM within the field of medical aesthetics are numerous and, based upon the way the proteins within the complex signal the body's own stem cells to rejuvenate and regenerate skin, potentially groundbreaking," said Dr. Gail K. Naughton, CEO and Chairman of the Board at Histogen. "This recognition from Suneva's expert team, with a rich background in developing and marketing aesthetics, validates Histogen's technology and supports the fact that it is different from anything currently in the market."

About Histogen Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, including low oxygen and suspension, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families a proprietary cell conditioned media, and a human Extracellular Matrix (ECM) material. For more information, please visit http://www.histogen.com.

About Suneva Medical Suneva Medical, Inc. is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the dermatology, plastic and cosmetic surgery markets. The Company's long-lasting injectable product is marketed as Artefill in the U.S. and Bellafill in Canada to correct facial wrinkles. For more information visit http://www.sunevamedical.com.

Contacts:

For Histogen Inc.:

Eileen Brandt Phone: (858) 200-9520 ebrandt@histogeninc.com

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The Alliance for Regenerative Medicine Statement on Use of Cell Therapies Not Approved by the Federal Drug …

Tuesday, March 6th, 2012

WASHINGTON, DC--(Marketwire -03/05/12)- The Alliance for Regenerative Medicine issued the following statement today: "An article about stem cell treatments taking place in Texas published by Nature last week is extremely troubling. The article suggests that patients are being administered stem cell treatments that have not been systematically demonstrated to be safe and effective therapies through the established FDA regulatory process.

"Cell therapy treatments, including those using adult stem cells, hold the promise of providing patients with treatments and cures for numerous diseases and disabilities. However, FDA regulation is key to ensuring that the treatments available to patients are safe and effective.

"The Alliance for Regenerative Medicine (ARM), a non-profit organization whose mission is to promote increased funding and development of regenerative medicine products, believes cell therapy and regenerative medicine products, including autologous cell therapy products, must go through the rigorous safety testing that is part of the FDA regulatory process before they can be marketed to the public. These regulations are designed to promote safe collection, manufacture, storage, and use of human cells, and cellular and tissue based products. ARM members comply with these rules because they know that FDA oversight helps to prevent patients from exposure to potentially unsafe products.

"We urge all companies developing stem cell treatments to follow FDA rules governing research and product development. ARM remains committed to working with all stakeholders to ensure that safe and effective products reach patients as soon as possible."

About The Alliance for Regenerative Medicine (ARM) The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based non-profit organization that promotes legislative, regulatory, reimbursement, and financing initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

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Cell find boosts liver disease hope

Monday, March 5th, 2012

Boosting the production of certain cells could help treat liver disease, new research has suggested.

Researchers at the Medical Research Council (MRC) Centre for Regenerative Medicine at the University of Edinburgh said they have discovered how to enhance the production of key cells needed to repair damaged liver tissue. The research could help develop treatments for diseases such as cirrhosis or chronic hepatitis.

Scientists hope their work could eventually ease the pressure on waiting lists for liver transplants. Researchers said that when the liver is damaged it produces too many bile duct cells and not enough cells called hepatocytes, which the liver needs to repair damaged tissue.

They found they could increase the number of hepatocyte cells - which detoxify the liver - by encouraging these cells to be produced instead of bile duct cells. Understanding how liver cells are formed could help to develop drugs to encourage the production of hepatocytes to repair liver tissue.

Professor Stuart Forbes, associate director at the MRC, who is a consultant hepatologist and was the academic leader of the study, said: "Liver disease is on the increase in the UK and is one of the top five killers. Increasing numbers of patients are in need of liver transplants, but the supply of donated organs is not keeping pace with the demand.

"If we can find ways to encourage the liver to heal itself then we could ease the pressure on waiting lists for liver transplants."

The production of hepatocyte cells was increased by altering the expression of certain genes in early stage liver cells. The university said that liver disease is the fifth biggest killer in the UK with almost 500 people waiting for a liver transplant, compared with just over 300 five years ago.

Dr Rob Buckle, head of regenerative medicine at the MRC, said: "Liver transplants have saved countless lives over the years, but demand will inevitably outstrip supply and in the long term we need to look beyond replacing damaged tissues to exploiting the regenerative potential of the human body.

"The MRC continues to invest heavily across the breadth of approaches that might deliver the promise of regenerative medicine, and this study opens up the possibility of applying our increasing knowledge of stem cell biology to stimulate the body's own dormant repair processes as a basis for future therapy."

The study is published in the journal Nature Medicine. It was carried out in collaboration with the University's MRC Centre for Inflammation Research, the Beatson Institute for Cancer Research in Glasgow and the KU Leuven in Belgium.

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Advanced Cell Technology Announces 2011 Financial Results

Thursday, March 1st, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT, OTCBB: ACTC), a leader in the field of regenerative medicine, today announced year-end results for the year ended December 31, 2011. The Company utilized $13.6 million in cash for operations during the year, compared to $8.8 million in the year-earlier period. The increase in cash utilization resulted primarily from ACTs ongoing clinical activities in the US and Europe. ACT ended the year with cash and cash equivalents of $13.1 million, compared to $15.9 million in cash and cash equivalents in the year-earlier period.

Some of the 2011 highlights included:

2011 was a very important and successful year for ACT as we began our Phase 1/2 trials for the treatment of macular degeneration, said Gary Rabin, chairman and CEO of ACT. We are very excited about the preliminary Phase 1/2 clinical data from our dry-AMD and Stargardts disease trials, which were published in The Lancet earlier this year. The data demonstrated the safety of ACTs human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells for the treatment of both diseases. The vision of both patients appears to have improved after transplantation, and no adverse safety issues have been observed. We look forward to validating these early findings as we expand these clinical activities throughout this year. Additionally, we made significant progress in advancing our scientific platform, expanding our board of directors and management team and strengthening our balance sheet.

The Company also announced today that it expects to shortly file a preliminary proxy statement with the Securities and Exchange Commission in which it will seek shareholder approval for a reverse split of between 1-for 20 and 1-for 80 shares. The Company is pursuing the reverse split for the sole purpose of meeting the requirements necessary for a listing on the Nasdaq Global Market. The Company believes that a listing on a national change will allow it to expand its shareholder base and improve the marketability of its common stock by attracting a broader range of investors.

Conference Call

The Company will hold a conference call at 9:00 a.m. EST tomorrow, during which it will discuss 2011 results and provide an update on clinical activities. Interested parties should dial (888)264-3177 followed by the reference conference ID number: 57426004. The call will be available live and for replay by webcast at: http://us.meeting-stream.com/advancedcelltechnology030212

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visitwww.advancedcell.com.

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International Cellular Medicine Society Grants First Worldwide Accreditation to Tijuana Clinical Trial

Wednesday, February 29th, 2012

Regenerative Medicine Institute, Mexico has been granted full accreditation for its clinical stem cell trials

Portland, Oregon (PRWEB) February 29, 2012

We are pleased that RMI undertook this process, says David Audley, executive director of the ICMS. The clinic understood that patient safety can only be assured through strict evaluation and rigorous oversight. From day one they have embraced the transparency that this program requires.

RMI is the first clinic to achieve this status under the ICMS Accreditation Program. The clinic has undergone two separate site audits as well as an institutional review board review evaluation. Most importantly, the clinic has placed in excess of 50 patients into the Treatment Registry for long-term outcome tracking. The safety profile has been excellent, continued Audley. We have tracked patients over at least two follow-ups and a minimum of six months and not seen a single cell-related adverse event.

The ICMS is currently evaluating nearly a dozen clinics worldwide. Accreditation is based upon the Guidelines for the Practice of Cell-Based Medicine developed and published by the ICMS. Key components of these guidelines are the ethical recruitment of patients, proper consent of patients and compliance with local laws and regulations in the treatment of patients.

###

Mr. David Audley International Cellular Medicine Society 503-884-6590 Email Information

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Stem Cell Pioneers Converge in Portland to Discuss and Celebrate a Revolutionary New Stem Cell Entering Human Clinical …

Wednesday, February 29th, 2012

SAN DIEGO, CA and PORTLAND, OR--(Marketwire -02/28/12)- Medistem Inc. (Pinksheets: MEDS.PK - News) announced today its Annual "Evening with Medistem" Event will take place in Portland, Oregon on March 7th, 2012. The event is being hosted by Vladimir Zaharchook, Vice Chairman at Medistem, Inc., and will feature stem cell luminaries and pioneers working with Medistem including Dr. Amit Patel, Director of Regenerative Medicine at University of Utah and the first person to administer stem cells into patients with heart failure, Dr. Michael Murphy, Vascular Surgeon at Indiana University and Principal Investigator for Medistem's FDA clinical trial in patients with risk of amputation, and Dr. Alan Lewis, former CEO of the Juvenile Diabetes Research Foundation, advisory board member of Medistem.

In 2007 Medistem discovered an entirely new type of stem cell, the Endometrial Regenerative Cell (ERC). This cell has proven it is a "universal donor" and can be used to treat many more conditions compared to other types of stem cells. The company received FDA clearance to begin clinical trials in September of 2011 for critical limb ischemia, a condition that is associated with amputation. Medistem is also running a Phase II clinical trial for heart failure using the new stem cell. The ERC stem cell does not involve the highly controversial use of fetal tissue, can be produced very economically and administered to the patient in a very simple manner. Medistem is exploring ways to expand clinical trials of its stem cell into other diseases.

"Stem cells and regenerative medicine offer hope in clinical conditions in which hope previously did not exist," said Dr. Stanley Cohan, Head of Neurology at the St Vincent's Hospital, the largest center for treatment of multiple sclerosis in the Pacific Northwest, who will be attending the event. "We are honored in the Portland community to have this distinguished team of accomplished researchers and medical doctors convene here and discuss with us possible collaborations."

"As a long-time member of the Portland academic community, it is exciting to have companies such as Medistem to visit us and share their experiences 'from the trenches' of what it takes to push a cellular drug through the FDA," said Dr. Shoukrat Milipotiv, Associate Scientist in the Division of Reproductive & Developmental Sciences of ONPRC, Oregon Stem Cell Center and Departments of Obstetrics & Gynecology and Molecular & Medical Genetics, and co-director of the ART/ESC core at the Center. He is an internationally recognized researcher in the area of stem cells.

"The Event is an annual celebration to honor our team and collaborators for the successes of the previous year, while at the same time educate the local business and medical community on the latest research on stem cells not just at Medistem but internationally," said Thomas Ichim, Ph.D Chief Executive Officer of Medistem Inc. "2012 is particularly exciting for us due to approvals for two clinical trials, and the initiation of patient treatments within this context."

About Medistem Inc.

Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure.

Cautionary Statement

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

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ISSCR Honors Stem Cell Research Pioneer with Prestigious McEwen Award for Innovation

Friday, February 24th, 2012

Newswise — The International Society for Stem Cell Research (ISSCR) is pleased to announce the winner of the 2012 McEwen Award for Innovation, a coveted prize in the field of stem cell research and regenerative medicine. The 2012 recipient is Rudolf Jaenisch, MD, Founding Member of the Whitehead Institute for Biomedical Research and Professor of Biology at the Massachusetts Institute of Technology in recognition of his pioneering discoveries in the areas of genetic and epigenetic control of development in mice that directly impact the future potential of embryonic stem cells and induced pluripotent stem cells for therapeutic utility.

The McEwen Award for Innovation is supported by the McEwen Centre for Regenerative Medicine in Toronto, Ontario, Canada. The $100,000 award honors original thinking and groundbreaking research pertaining to stem cells or regenerative medicine that opens new avenues of exploration towards the understanding or treatment of human disease or affliction.

“Rudolf Jaenisch has consistently contributed new and groundbreaking discoveries to stem cell biology and regenerative medicines that have changed the way stem cell research is conducted, said Fred H. Gage, PhD, ISSCR President. “Importantly, Rudolf not only has an uncanny sense of the next big question, but also conducts his experiments with such thoughtful and critical experimental design that his results have an immediate impact. This critical attention to detail and experimental design has greatly benefited the many gifted students that have passed through his lab and now populate many of the major stem cell centers throughout the world. Rudolf is very deserving of this award.”

Winner of the inaugural McEwen Award for Innovation in 2011, Shinya Yamanaka, MD, PhD, ISSCR President-Elect agrees. “Dr. Rudolf Jaenisch has always been on the cutting-edge of our field and his research has been a source of inspiration not only for myself, but has influenced the careers of some of our most esteemed colleagues.”

Dr. Jaenisch will be presented with the award at the ISSCR 10th Annual Meeting, in Yokohama, Japan, on Wednesday, June 13, 2012.
***
The International Society for Stem Cell Research is an independent, nonprofit membership organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application.

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Makucell™ Announces Key Scientific Presentations and Launch of a Large, Multicenter Use Study of Asymmtate™

Wednesday, February 22nd, 2012

 

 

SCOTTSDALE, Ariz., Feb. 21, 2012 /PRNewswire-USNewswire/ -- Makucell, Inc., a new life science company that utilizes an innovative proprietary regenerative medicine technology to address aging skin, hair and nail conditions, has presented important pre-clinical and clinical information on its proprietary molecule, Asymmtate, at the 36th Annual Hawaii Dermatology Seminar, Waikoloa, Hawaii.  Asymmtate™ is the active key ingredient in Makucell's new topical skin care line Renewnt™ (pronounced "Re-new-int").

Asymmtate™ is a selective modulator of the Wnt (pronounced "wint") signaling pathway that encourages optimal signaling to stimulate skin stem cells to replenish themselves, keratinocytes, fibroblasts and other dermal cells, which produce collagen, elastic tissue, matrix and other substances to foster a more healthy, rejuvenated appearing skin.  Renewnt™ will be available through aesthetic dermatology professionals in April 2012.

Mark Dahl, M.D. Makucell's, Vice President and Chief Medical Officer, presented the two scientific poster presentations.   The presentation titles and conclusions are summarized below.

The Safety and Efficacy of Asymmtate – Asymmtate™ penetrates into human epidermis and dermis and remains active.  Asymmtate in its cream vehicles is non-mutagenic, non-irritating, and non-sensitizing.  Asymmtate™ Analog Mitigates Photoaging Effects of UVB in Mice – An analog of Asymmtate applied topically can mitigate the subsequent visible appearance of photoaging changes in mice after exposures of their skin to UVB.

In addition to the pre-clinical/clinical information presented this week, Makucell has initiated a 100 subject Use Study to evaluate the safety and efficacy of Renewnt™ for Hydration Day and Night Moisturizer in a real world setting.  This four-week study will include 12 investigator sites across the U.S.  "This large multicenter study is very important to validate aspects of clinical product performance of Asymmtate™ under real world conditions.  The diverse geographical study sites will allow us to evaluate effects on unique skin types in different climates," said Lawrence A. Rheins, President and CEO of Makucell.

The innovative technology that resulted in the formulation of Renewnt was developed by distinguished research scientist Michael Kahn, Ph.D. and colleagues at the Eli & Edythe Broad Center for Stem Cell and Regenerative Medicine at the University of Southern California, Keck School of Medicine. "This is an exciting time for Makucell," said Makucell co-founder and inventor Michael Kahn, Ph.D.  "This technology will be utilized for commercial topical applications to address the challenges of photoaging skin and other hair and nail conditions."

For media and investment inquiries please contact please contact Lawrence Rheins, lrheins@makucellinc.com or 1-855-MAKUCELL.

About Makucell
Makucell (www.makucell.com) is a new life science technology transfer company that utilizes an innovative proprietary regenerative medicine technology to address aging skin, hair and nail conditions in an entirely new way. Using a patent-pending new molecule, Asymmtate, Makucell has developed the Renewnt brand of non-prescription products that work with the skin's own stem cells to produce healthier, and more youthful appearing skin. This innovative technology was developed by researchers at the Eli & Edythe Broad Center for Stem Cell and Regenerative Medicine at the University of Southern California Keck School of Medicine.  Makucell is financed through private investors and is not in receipt of government funding.

About the USC Stevens Institute for Innovation
The USC Stevens Institute for Innovation (http://stevens.usc.edu) is a university-wide resource in the Office of the Provost at the University of Southern California that helps identify, nurture, protect, and transfer to the market the most exciting innovations from USC.  It also provides a central connection for industry seeking cutting-edge innovations in which to invest. As part of this role, the USC Stevens Institute manages the university's intellectual property portfolio stemming from its $560M annual research program. Furthermore, the USC Stevens Institute develops the innovator as well as innovations, through educational programs, community-building events, and showcase opportunities.

Media Contact:
Lawrence Rheins
lrheins@makucellinc.com
1-480-305-2061

SOURCE USC Stevens Institute for Innovation

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http://www.stevens.usc.edu
http://www.makucell.com/

Original post:
Makucell™ Announces Key Scientific Presentations and Launch of a Large, Multicenter Use Study of Asymmtate™

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Makucell(TM) Announces Key Scientific Presentations and Launch of a Large, Multicenter Use Study of Asymmtate(TM)

Wednesday, February 22nd, 2012

To: HEALTH, MEDICAL AND NATIONAL EDITORS

SCOTTSDALE, Ariz., Feb. 21, 2012 /PRNewswire-USNewswire/ -- Makucell, Inc., a new life science company that utilizes an innovative proprietary regenerative medicine technology to address aging skin, hair and nail conditions, has presented important pre-clinical and clinical information on its proprietary molecule, Asymmtate, at the 36th Annual Hawaii Dermatology Seminar, Waikoloa, Hawaii. Asymmtate(TM) is the active key ingredient in Makucell's new topical skin care line Renewnt(TM) (pronounced "Re-new-int").

Asymmtate(TM) is a selective modulator of the Wnt (pronounced "wint") signaling pathway that encourages optimal signaling to stimulate skin stem cells to replenish themselves, keratinocytes, fibroblasts and other dermal cells, which produce collagen, elastic tissue, matrix and other substances to foster a more healthy, rejuvenated appearing skin. Renewnt(TM) will be available through aesthetic dermatology professionals in April 2012.

Mark Dahl, M.D. Makucell's, Vice President and Chief Medical Officer, presented the two scientific poster presentations. The presentation titles and conclusions are summarized below.

-- The Safety and Efficacy of Asymmtate - Asymmtate(TM) penetrates into human epidermis and dermis and remains active. Asymmtate in its cream vehicles is non-mutagenic, non-irritating, and non-sensitizing. -- Asymmtate(TM) Analog Mitigates Photoaging Effects of UVB in Mice - An analog of Asymmtate applied topically can mitigate the subsequent visible appearance of photoaging changes in mice after exposures of their skin to UVB.

In addition to the pre-clinical/clinical information presented this week, Makucell has initiated a 100 subject Use Study to evaluate the safety and efficacy of Renewnt(TM) for Hydration Day and Night Moisturizer in a real world setting. This four-week study will include 12 investigator sites across the U.S. "This large multicenter study is very important to validate aspects of clinical product performance of Asymmtate(TM) under real world conditions. The diverse geographical study sites will allow us to evaluate effects on unique skin types in different climates," said Lawrence A. Rheins, President and CEO of Makucell.

The innovative technology that resulted in the formulation of Renewnt was developed by distinguished research scientist Michael Kahn, Ph.D. and colleagues at the Eli & Edythe Broad Center for Stem Cell and Regenerative Medicine at the University of Southern California, Keck School of Medicine. "This is an exciting time for Makucell," said Makucell co-founder and inventor Michael Kahn, Ph.D. "This technology will be utilized for commercial topical applications to address the challenges of photoaging skin and other hair and nail conditions."

For media and investment inquiries please contact please contact Lawrence Rheins, lrheins@makucellinc.com or 1-855-MAKUCELL.

About Makucell

Makucell (www.makucell.com) is a new life science technology transfer company that utilizes an innovative proprietary regenerative medicine technology to address aging skin, hair and nail conditions in an entirely new way. Using a patent-pending new molecule, Asymmtate, Makucell has developed the Renewnt brand of non-prescription products that work with the skin's own stem cells to produce healthier, and more youthful appearing skin. This innovative technology was developed by researchers at the Eli & Edythe Broad Center for Stem Cell and Regenerative Medicine at the University of Southern California Keck School of Medicine. Makucell is financed through private investors and is not in receipt of government funding.

About the USC Stevens Institute for Innovation

The USC Stevens Institute for Innovation (http://stevens.usc.edu) is a university-wide resource in the Office of the Provost at the University of Southern California that helps identify, nurture, protect, and transfer to the market the most exciting innovations from USC. It also provides a central connection for industry seeking cutting-edge innovations in which to invest. As part of this role, the USC Stevens Institute manages the university's intellectual property portfolio stemming from its $560M annual research program. Furthermore, the USC Stevens Institute develops the innovator as well as innovations, through educational programs, community-building events, and showcase opportunities.

Media Contact:

Lawrence Rheinslrheins@makucellinc.com1-480-305-2061

SOURCE USC Stevens Institute for Innovation

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Makucell(TM) Announces Key Scientific Presentations and Launch of a Large, Multicenter Use Study of Asymmtate(TM)

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