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ViroPharma Announces Initiation of Clinical Studies to Evaluate Maribavir for Treatment of Cytomegalovirus (CMV …

June 4th, 2012 4:16 pm

EXTON, Pa., June 4, 2012 /PRNewswire/ -- ViroPharma Incorporated (VPHM) today announced the initiation of a Phase 2 program to evaluate maribavir for the treatment of cytomegalovirus infections in transplant recipients. The planned program will consist of two independent Phase 2 clinical studies that will include subjects at different ends of the spectrum of CMV infection or disease, namely those who have asymptomatic CMV, and those who have failed therapy with other anti-CMV agents. Maribavir was granted U.S. Orphan Drug Designation in May of 2011 for treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.

In addition, an abstract of data collected through the use of maribavir at six French transplant centers as part of a named patient program (NPP) has been accepted for the 24th International Congress of the Transplantation Society to be held on July 15th through 19th in Berlin, Germany.

"Physicians continue to see potential value in the novel mechanism of action of maribavir when used at higher doses in critically ill patients, particularly when other options have failed," stated Marc E. Uknis, MD, medical director, ViroPharma Incorporated. "The outcomes seen in a small number of the NPP patients and the previously published experience in emergency-use IND patients suggests the possibility that maribavir may provide meaningful antiviral effects in treating active CMV infection and merits further careful evaluation because of the serious unmet need in immunocompromised transplant patients."

"Asymptomatic" CMV Study ViroPharma has initiated a randomized, dose blinded multicenter Phase 2 study intended to enroll up to 160 subjects (recipients of either hematopoietic stem cell or solid organ transplant) who have demonstrated CMV viremia but do not have CMV organ disease. Further, these subjects cannot have CMV infection that is resistant to other anti-CMV agents. Subjects will be randomized to receive oral maribavir at one of three doses (400mg, 800mg or 1200mg BID) or valganciclovir for up to 12 weeks. Blood levels of CMV DNA will be monitored throughout the study, and minimum virologic responses will be required after 3 and 6 weeks of treatment to continue study drug. The study will be conducted at multiple transplant centers in 3-4 countries in Europe.

Resistant/Refractory CMV Study ViroPharma is planning to initiate a second study, a randomized, dose blinded multicenter Phase 2 study intended to enroll up to 120 subjects (recipients of either hematopoietic stem cell or solid organ transplant) who have demonstrated CMV viremia with or without CMV organ disease. All subjects will have failed to have an adequate virologic response to prior treatment with ganciclovir, valganciclovir, or foscarnet, and may have documented viral genetic resistance to any of these anti-CMV agents. Subjects will be randomized to receive oral maribavir at one of three doses (400mg, 800mg or 1200mg BID) for up to 24 weeks. Blood levels of CMV DNA will be monitored throughout the study, and minimum virologic responses will be required after 3 and 6 weeks of treatment to continue study drug. The study is planned to be conducted at multiple transplant centers in the United States.

About Maribavir Maribavir, a member of a new class of drugs called benzimidazole ribosides, is a potent and selective, orally bioavailable antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable clinical safety profile. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, maribavir inhibits viral DNA assembly and inhibits egress of viral capsids from the nucleus of infected cells. Maribavir is active in vitro against strains of CMV that are resistant to commonly used anti-CMV drugs. The previous focus of clinical development of maribavir as an anti-CMV agent was on the prevention of CMV disease in transplant patients. Results from Phase 3 studies indicated that maribavir at a dose of 100mg BID failed to meet its efficacy endpoints; however, maribavir has demonstrated a favorable safety and tolerability profile in all clinical studies to date. While Phase 3 studies of CMV prophylaxis at the 100mg BID dose did not show sufficient activity to prevent CMV disease, the overall safety profile of maribavir and limited data from cases in which open-label maribavir was used as CMV treatment suggest that higher doses may provide clinical activity. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to maribavir in May of 2011 for treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.

About Cytomegalovirus CMV is a memberof the herpesvirus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and herpes genitalis (genital herpes). Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50 percent and 85 percent of adults in the U.S. by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals including cancer patients, HIV patients, and transplant patients, and in children born with primary CMV infection, CMV can lead to serious disease or death. Patients who are immunosuppressed following hematopoietic stem cell (bone marrow) or solid organ transplantation are at high risk of CMV infection. In these patients, CMV can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment.

About ViroPharma Incorporated ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing novel solutions for physician specialists to address unmet medical needs of patients living with diseases that have few if any clinical therapeutic options. ViroPharma is developing a portfolio of therapeutics for rare and Orphan diseases including C1 esterase inhibitor deficiency, Friedreich's Ataxia, and adrenal insufficiency, cytomegalovirus (CMV); and recurrent C. difficile infection (CDI). Our goal is to provide rewarding careers to employees, to create new standards of care in the way serious diseases are treated, and to build international partnerships with the patients, advocates, and health care professionals we serve. ViroPharma's commercial products address diseases including hereditary angioedema (HAE), seizures, adrenal insufficiency and C. difficile-associated diarrhea (CDAD); for full U.S. prescribing information on our products, please download the package inserts at http://www.viropharma.com/Products.aspx; the prescribing information for other countries can be found at http://www.viropharma.com.

ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's web site, http://www.viropharma.com. The company encourages investors to consult these sections for more information on ViroPharma and our business.

Forward Looking Statements Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events, including the therapeutic indication and use, safety, efficacy, tolerability and potential of maribavir and our focus, goals, strategy, research and development programs, and ability to develop pharmaceutical products, commercialize pharmaceutical products, and execute on our plans including clinical development activities with maribavir related to treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease. In February 2009, based upon preliminary analysis of the data, we announced that our Phase 3 trial evaluating maribavir used as prophylaxis in allogeneic stem cell, or bone marrow, transplant patients did not achieve its primary endpoints. In addition, the study failed to meet its key secondary endpoints. Additionally, we announced that our Phase 3 trial evaluating maribavir in liver transplant patients was discontinued and that all patients on study drug were moved to current standard of care. While the current studies are in different patient populations and utilize different dosing levels, there can be no assurance that our clinical program with maribavir for the treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease will yield positive results or support further development of maribavir for either indication. The preliminary results from a small number of NPP and emergency-use IND patients may not be predictive of the results of the studies described in this press release. The FDA or EMA may view the data regarding maribavir for the treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease as insufficient or inconclusive, request additional data, require additional clinical studies, delay any decision past the time frames anticipated by us, limit any approved indications, or deny the approval of maribavir for the treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease.

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Stem cells tested for heart attack repair

June 4th, 2012 4:13 pm

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Medistem Achieves Important ERC Stem Cell Clinical Trial Milestone

June 4th, 2012 12:13 pm

SAN DIEGO, CA--(Marketwire -06/04/12)- Medistem Inc. (MEDS) announced today positive safety data from the first 5 patients enrolled in the Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC) trial. The clinical trial uses the company's "Universal Donor" Endometrial Regenerative Cells (ERC) to treat Congestive Heart Failure (CHF).

According to the study design, after 5 patients enter the trial, they must be observed for a two month time period before additional patients are allowed to enter the study. Patient data was analyzed by the study's independent Data Safety Monitoring Board (DSMB), which concluded that based on lack of adverse effects, the study be allowed to continue recruitment.

"Medistem is developing a treatment for CHF that uses a 30-minute catheter-based procedure to administer the ERC stem cell into the patients' hearts. The achievement of 2 month patient follow-up with no adverse events is a strong signal for us that our new approach to this terrible condition is feasible," said Thomas Ichim, CEO of Medistem.

The RECOVER-ERC trial will treat a total of 60 patients with end-stage heart failure with three concentrations of ERC stem cells or placebo. The clinical trial is being conducted by Dr. Leo Bockeria, Chairman of the Backulev Centre for Cardiovascular Surgery, in collaboration with Dr. Amit Patel, Director of Clinical Regenerative Medicine at University of Utah.

"As a professional drug developer, I am very optimistic of a stem cell product that can be used as a drug. The ERC stem cell can be stored frozen indefinitely, does not need matching with donors, and can be injected in a simple 30-minute procedure into the heart," said Dr. Sergey Sablin, Vice President of Medistem and co-founder of the multi-billion dollar NASDAQ company Medivation.

Currently patients with end-stage heart failure, such as the ones enrolled in the RECOVER-ERC study, have no option except for heart transplantation, which is limited by side effects and lack of donors. In contrast to other stem cells, ERC can be manufactured inexpensively, do not require tissue matching, and can be administered in a minimally-invasive manner. Animal experiments suggest ERC are more potent than other stem cell sources at restoring heart function. The FDA has approved a clinical trial of ERC in treatment of critical limb ischemia in the USA.

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. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.

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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OncoMed Presents First-in-Human Phase I Data on Anti-Notch2/3 Antibody at ASCO

June 3rd, 2012 4:17 am

CHICAGO--(BUSINESS WIRE)--

OncoMed Pharmaceuticals, Inc., a privately held, clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor initiating cells, today highlighted new data presented this afternoon in a poster discussion session at the Annual Meeting of the American Society for Clinical Oncology (ASCO) in Chicago, IL. This represents the first clinical presentation of OMP-59R5, a monoclonal antibody targeting the Notch2 and Notch3 receptors. Authors of the poster, A First-in-Human Phase I Study to Evaluate the Fully Human Monoclonal Antibody OMP-59R5 (anti-Notch2/3) Administered Intravenously to Patients with Advanced Solid Tumors, concluded that OMP-59R5 was generally well tolerated and established maximum tolerated doses (MTDs) of 2.5mg/kg weekly (QW) and 5mg/kg every other week (QoW) for the drug.

The study results were presented by Dr. Anthony Tolcher of The START Center for Cancer Care, San Antonio, TX. Dr. Tolcher noted that the main treatment-related adverse event was diarrhea and there was evidence of Notch pathway modulation with this drug. Dr. David Smith and colleagues at the University of Michigan Cancer Center at Ann Arbor, MI also participated in the Phase I study. The anti-Notch2/3 program is part of OncoMeds collaboration with GlaxoSmithKline.

The Phase I dose-escalation study (3+3 design) was initiated in patients with advanced solid tumors. The investigational antibody, OMP-59R5, was administered to study safety, pharmacokinetics (PK), pharmacodynamics (PD), preliminary efficacy, and to determine the MTD. Thirty patients have been enrolled in four dose-escalation cohorts at doses of 0.5, 1, 2.5, and 5mg/kg administered weekly, as well as two dose-escalation cohorts of 5 and 10mg/kg administered every other week. The study is ongoing and will test an every-three-week dosing schedule.

The most frequently reported drug-related adverse events were: mild to moderate diarrhea, fatigue, nausea, vomiting, decreased appetite, and constipation. Diarrhea was dose related and occurred at doses 2.5mg/kg weekly and appeared less pronounced with every-other-week dosing. The PK of OMP-59R5 was characterized by rapid, dose-dependent clearance. Several patients had prolonged stable disease for 56 days (tumor types included Kaposis Sarcoma, adenoid cystic carcinoma, rectal cancer, and liposarcoma). PD modulation of Notch pathway was detectable in surrogate tissue and in tumor and occurred at doses 1mg/kg. The OMP-59R5 clinical program is advancing toward PhIb/II development in solid tumor indications.

About Anti-Notch2/3

The Notch pathway plays a central role in embryonic development, the regulation of stem and progenitor cells, and is implicated centrally in many human cancers. OMP-59R5 is a fully human IgG2 monoclonal antibody originally identified by binding to Notch2. It inhibits the signaling of both Notch2 and Notch3 receptors. Mouse xenograft studies using minimally-passaged, patient-derived xenografts have shown that OMP-59R5 impedes tumor growth and eliminates CSCs in many tumor types. OMP-59R5 modulates the expression of stromal genes and genes associated with the function of tumor vascular pericytes. Based on preclinical experiments, we believe that OMP-59R5 is a novel anti-cancer agent that inhibits tumor growth through direct actions on tumor cells, including CSCs, and effects on the stroma and vasculature.

About Cancer Stem Cells

Cancer stem cells, a small, resilient subset of cells found in tumors, have the capacity to self-renew and differentiate, leading to tumor initiation and driving tumor growth, recurrence and metastasis. Also referred to as tumor-initiating cells, these cells were first discovered by OncoMeds scientific founders in breast cancer and have subsequently been identified in many other tumor types, including brain, colon, lung, prostate, and pancreatic cancer. Cancer stem cells appear to be preferentially resistant to both standard chemotherapy and radiotherapy. OncoMeds strategy is to improve cancer treatment by specifically targeting the key biologic pathways that are thought to be critical to the activity and survival of cancer stem cells. OncoMeds antibody therapeutics target cancer stem cell proteins and have the potential to be developed against a range of tumor types.

About OncoMed Pharmaceuticals

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OncoMed Presents First-in-Human Phase I Data on Anti-Notch2/3 Antibody at ASCO

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Stem cell therapy for cornea treatment

June 2nd, 2012 3:15 pm

Hyderabad, June 2:

Picking stem cells from a patients body, sending it to a sophisticated laboratory to culture a tissue and then implanting it are pass.

A team of doctors at L.V. Prasad Eye Institute has used the tea bag or sprinkler approach to regenerate stem cells. The organisation has developed a lab-free technique that could be available off-the-shelf. This allows eye surgeons with usual facilities to perform the procedure.

The team, led by Dr Virender Singh Sangwan, used this technique to treat those who suffered chemical injuries, resulting in bleeding in the cornea.

Instead of sending stem cells to the lab for culture, the doctor picked the required number of stem cells around the cornea and sprinkled on the damaged area and then put a contact lens. In 15 days, he sees development of a good layer in the place of injured area, Prof. Balasubramanian, Head of Research at LVPEI, said.

A winner of the prestigious Shanti Swarup Bhatnagar prize, Dr Sangwan said he had conducted the procedure on about 25 patients with good results. This had been published in international scientific magazines.

He is now in the process of developing tools to help doctors.

Leber Congenital Amaurosis

Children down with the rare ocular disorders that result in gradual loss of sight can hope for a cure. Doctors are working on a gene therapy to correct this problem caused by consanguineous marriages.

Though this therapy is in vogue abroad, LVPEI says it is the first centre to carry out research on this procedure. Technically called LCA or Leber Congenital Amaurosis, doctors would refer patients to a gene analysis after studying them for indications.

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Stem cell therapy for cornea treatment

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Stem cell therapy for cornea treatment

June 2nd, 2012 2:14 pm

Hyderabad, June 2:

Picking stem cells from a patients body, sending it to a sophisticated laboratory to culture a tissue and then implanting it are pass.

A team of doctors at L.V. Prasad Eye Institute has used the tea bag or sprinkler approach to regenerate stem cells. The organisation has developed a lab-free technique that could be available off-the-shelf. This allows eye surgeons with usual facilities to perform the procedure.

The team, led by Dr Virender Singh Sangwan, used this technique to treat those who suffered chemical injuries, resulting in bleeding in the cornea.

Instead of sending stem cells to the lab for culture, the doctor picked the required number of stem cells around the cornea and sprinkled on the damaged area and then put a contact lens. In 15 days, he sees development of a good layer in the place of injured area, Prof. Balasubramanian, Head of Research at LVPEI, said.

A winner of the prestigious Shanti Swarup Bhatnagar prize, Dr Sangwan said he had conducted the procedure on about 25 patients with good results. This had been published in international scientific magazines.

He is now in the process of developing tools to help doctors.

Leber Congenital Amaurosis

Children down with the rare ocular disorders that result in gradual loss of sight can hope for a cure. Doctors are working on a gene therapy to correct this problem caused by consanguineous marriages.

Though this therapy is in vogue abroad, LVPEI says it is the first centre to carry out research on this procedure. Technically called LCA or Leber Congenital Amaurosis, doctors would refer patients to a gene analysis after studying them for indications.

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Biostem U.S., Corporation Presents Scientific and Medical Board of Advisors Publications

June 2nd, 2012 1:14 am

CLEARWATER, FL--(Marketwire -06/01/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine science sector, has made its Scientific and Medical Board of Advisors publications available on the company website, http://www.biostemus.com.

Chief Executive Officer Dwight Brunoehler stated, "The company is very proud of the many contributions its SAMBA members have made, and continue to make, to the medical community. As their publications and credentials show, this is a very prestigious and influential group. Having worked with them in past projects and now at Biostem, I know them all to be active participants in the development and guidance of the company's objectives. Their diversified areas of expertise and backgrounds are already playing a major role in assisting the company as it moves forward into the expanding field of regenerative medicine."

About Biostem U.S., Corporation Biostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on 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., Corporation 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 Fox Communications Group 310-974-6821.

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Malta opposing EU financing for stem cell research on embryos

June 2nd, 2012 1:14 am

Stem cell therapy may one day be used to cure disorders such as Fragile-X syndrome, or Cystic fibrosis and other genetic maladies.

Matthew Vella

The Maltese government wants the European Commission to abandon plans to provide funds for research activities on stem cells that involve "the destruction of human embryos".

In a declaration on the ethical principles for the Horizon 2020 programme, which is an 80 billion fund for the EU's programme for research and innovation to create new jobs, the Maltese government said it wanted more detailed guidelines on the bioethical principles that will guide research programmes.

Horizon 2020 will allow the financing of research on human stem cells - both adult and embryonic - as long as it is permitted by the national laws of member states.

The fund however will not finance human cloning, genetic modification, or the creation of human embryos intended for the purpose of research or stem cell procurement.

The European Commission does not explicitly solicit the use of human embryonic stem cells, but Horizon 2020 allows the use of human stem cells according to the objectives of the research, and only if it has the necessary approvals from the member states.

The Maltese declaration echoes previous statements by the Commission of Catholic Bishops of the EC (Comece), which said Horizon 2020 did not include greater protection of human embryos from stem cell research.

Malta says it does not want any such embryos to be used for stem cell research. The statement by the Maltese government said the Horizon 2020 programme "does not take sufficiently into account the therapeutic potential of human adult stem cells."

Malta wants Europe to commit to a reinforcement of research on human adult stem cells, and that Europe should abstain from financing matters of fundamental ethical principles, which differ among member states.

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Stemedica Takes Part in Mexican Clinical Trial

June 2nd, 2012 12:16 am

Stem cells provided by San Diego-based Stemedica Cell Technologies Inc. are expected to be used soon in a phase I/II clinical trial for chronic heart failure in Mexico.

Stemedica announced May 29 that its strategic Mexico partner, Grupo Angeles Health Services, has received approval for a single-blind randomized clinical trial from Mexicos FDA equivalent regulatory agency, COFEPRIS.

The trial being conducted at multiple hospital sites throughout Mexico will involve Stemedicas adult allogeneic ischemia tolerant mesenchymal stem cells delivered via intravenous infusion. The trial will involve three safety cohorts at different dosages, followed by a larger group being treated with the maximum safe dosage.

The trial, set to begin on or before July 1 with 60 to 80 patients, is one of only two studies using allogeneic stem cells approved by COFEPRIS. The other study approved in 2010 was a clinical trial for ischemic stroke.

We are pleased that we will be working with the largest and most prestigious private medical institution in Mexico to study Stemedicas product for this indication, said Stemedica CEO Maynard Howe in a statement. If successful, our stem cells may provide a treatment option for the millions of patients, both in Mexico and internationally, who suffer from this condition.

Grupo Angeles, comprised of 24 state-of-the-art hospitals, conducts some 100 clinical trials annually, primarily with major global pharmaceutical and medical device companies.

Stemedica stem cells are also currently being used in a phase I/IIa trial for stroke patients at UC San Diego. The 36-patient clinical trial has been progressing about a year and is moving into its third and final cohort, said Dave McGuigan, vice president of marketing and business development for the company. When patient treatments are completed by the end of September, data will be evaluated to determine whether it moves to a full phase IIb trial to primarily determine efficacy in a larger population of 60 to 80 patients, McGuigan said.

Our next step would be to initiate a phase II clinical trial in multiple sites across the U.S. in 2013, he said.

Founded seven years ago, the privately held Stemedica specialty biopharmaceutical company has about 46 locally based employees in the U.S. and an additional eight staff in Switzerland, South Korea and Singapore.

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Stemedica Takes Part in Mexican Clinical Trial

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Biostem U.S., Corporation Presents Scientific and Medical Board of Advisors Publications

June 2nd, 2012 12:15 am

CLEARWATER, FL--(Marketwire -06/01/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine science sector, has made its Scientific and Medical Board of Advisors publications available on the company website, http://www.biostemus.com.

Chief Executive Officer Dwight Brunoehler stated, "The company is very proud of the many contributions its SAMBA members have made, and continue to make, to the medical community. As their publications and credentials show, this is a very prestigious and influential group. Having worked with them in past projects and now at Biostem, I know them all to be active participants in the development and guidance of the company's objectives. Their diversified areas of expertise and backgrounds are already playing a major role in assisting the company as it moves forward into the expanding field of regenerative medicine."

About Biostem U.S., Corporation Biostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on 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., Corporation 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 Fox Communications Group 310-974-6821.

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Biostem U.S., Corporation Presents Scientific and Medical Board of Advisors Publications

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Malta opposing EU financing for stem cell research on embryos

June 2nd, 2012 12:12 am

Stem cell therapy may one day be used to cure disorders such as Fragile-X syndrome, or Cystic fibrosis and other genetic maladies.

Matthew Vella

The Maltese government wants the European Commission to abandon plans to provide funds for research activities on stem cells that involve "the destruction of human embryos".

In a declaration on the ethical principles for the Horizon 2020 programme, which is an 80 billion fund for the EU's programme for research and innovation to create new jobs, the Maltese government said it wanted more detailed guidelines on the bioethical principles that will guide research programmes.

Horizon 2020 will allow the financing of research on human stem cells - both adult and embryonic - as long as it is permitted by the national laws of member states.

The fund however will not finance human cloning, genetic modification, or the creation of human embryos intended for the purpose of research or stem cell procurement.

The European Commission does not explicitly solicit the use of human embryonic stem cells, but Horizon 2020 allows the use of human stem cells according to the objectives of the research, and only if it has the necessary approvals from the member states.

The Maltese declaration echoes previous statements by the Commission of Catholic Bishops of the EC (Comece), which said Horizon 2020 did not include greater protection of human embryos from stem cell research.

Malta says it does not want any such embryos to be used for stem cell research. The statement by the Maltese government said the Horizon 2020 programme "does not take sufficiently into account the therapeutic potential of human adult stem cells."

Malta wants Europe to commit to a reinforcement of research on human adult stem cells, and that Europe should abstain from financing matters of fundamental ethical principles, which differ among member states.

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Malta opposing EU financing for stem cell research on embryos

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NCAA baseball: Mike Kent of Clemson’s biggest save came away from the diamond

June 1st, 2012 5:15 am

CLEMSON, S.C. The cells Mike Kents own cells, the donated stem cells now coursing through his stricken brothers body are working just fine. Thats what they tell him. His family and the doctors are careful to shield Mike, just 21 years old, from most of the bad news regarding Matts battle with Hodgkins lymphoma and lately there has been plenty of it. But they always make sure to tell him: Your cells are doing great.

It can mess with your head, being a stem-cell donor to your own brother. If something goes wrong, it is only natural to wonder if it was your fault. Were your cells bad? And Mike Kent, a 2009 Washington Post All-Met selection at West Springfield High, has enough on his plate right now not just Matts three-year fight with cancer, but also his own baseball career at Clemson to be saddled with all that guilt. Clemson opens play in the NCAA regionals at Columbia, S.C., on Friday.

(Family photo) - Mike Kent, right, poses with his brother, Matt, when Mike was a high school senior and a pitcher for the West Springfield, Va, baseball team.

Because now, Matts liver is failing, the veins breaking down from the high doses of chemotherapy and radiation. He floats in and out of consciousness in the intensive-care unit at the University of Maryland Medical Center in Baltimore, unaware of his surroundings.

Ill be honest: Ive asked them, Is he going to survive this? said Susan Kent, Matt and Mikes mother, a look of sheer resolve on her face. Of course, the doctors wont answer.

Such an awkward spot for a mother who had raised two boys on her own. One of them, a college sophomore, is playing out his dream, preparing to pitch in college baseballs national championship tournament, his life spread out before him. The other son, 26 years old and a late-bloomer who was just starting to get his life in order before the diagnosis, is fighting for his life.

How do you handle such a fate? You play up the positives, thats how. You visit Matt in the hospital Matt being the one who taught Mike the game of baseball, in the absence of a father and you tell him, in great detail, about all of Mikes solid outings at Clemson: the scoreless relief appearances, the saves. And you spare him the gory details about the ugly ones the three-run homers, the bases-loaded walks, the losses.

And you give Mike the barest of details about Matts setbacks: There are some complications. Some side effects. But while Mike knows most of the more pertinent information the liver failure, the ICU you emphasize what is important, the thing Mike needs to know: Your cells are doing great.

Throwing extra innings

The injections, the doctors told Mike, would make him feel like he had the flu. The drug, Neupogen, was being given in eight doses, spread over four days to produce and stimulate white blood cells in his body in preparation for the stem cell transplant. One thing he shouldnt try to do, they told him, was play baseball.

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NCAA baseball: Mike Kent of Clemson’s biggest save came away from the diamond

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Mechanism that maintains stem cells readiness identified

June 1st, 2012 5:15 am

ScienceDaily (May 31, 2012) An immune-system receptor plays an unexpected but crucially important role in keeping stem cells from differentiating and in helping blood cancer cells grow, researchers at UT Southwestern Medical Center report today in the journal Nature.

"Cancer cells grow rapidly in part because they fail to differentiate into mature cells. Drugs that induce differentiation can be used to treat cancers," said Dr. Chengcheng "Alec" Zhang, assistant professor in UT Southwestern's departments of physiology and developmental biology. "Our research identified a protein receptor on cancer cells that inhibits differentiation, and knowing the identity of this protein should facilitate the development of new drugs to treat cancers."

The family of proteins investigated in the study could help open a new field of biology integrating immunology with stem cell and cancer research, he added.

"The receptor we identified turned out to be a protein called a classical immune inhibitory receptor, which is known to maintain stemness of normal adult stem cells and to be important in the development of leukemia," he said.

Stemness refers to the blood stem cells' potential to develop into a range of different kinds of cells as needed, for instance to replenish red blood cells lost to bleeding or to produce more white blood cells to fight off infection. Once stem cells differentiate into adult cells, they cannot go back to being stem cells. Current thinking is that the body has a finite number of stem cells and it is best to avoid depleting them, Dr. Zhang explained.

Prior to this study, no high-affinity receptors had been identified for the family of seven proteins called the human angiopoetic-like proteins. These seven proteins are known to be involved in inflammation, supporting the activity of stem cells, breaking down fats in the blood, and growing new blood vessels to nourish tumors. Because the receptor to which these proteins bind had not been identified, the angiopoetic-like proteins were referred to as "orphans," he said.

The researchers found that the human immune-inhibitory receptor LILRB2 and a corresponding receptor on the surface of mouse cells bind to several of the angiopoetic-like proteins. Further studies, Dr. Zhang said, showed that two of the seven family members bind particularly well to the LILRB2 receptor and that binding exerts an inhibitory effect on the cell, similar to a car's brakes.

In the case of stem cells, inhibition keeps them in their stem state. They retain their potential to mature into all kinds of blood cells as needed but they don't use up their energy differentiating into mature cells. That inhibition helps stem cells maintain their potential to create new stem cells because in addition to differentiation, self-renewal is the cells' other major activity, Dr. Zhang said. He stressed that the inhibition doesn't cause them to create new stem cells but does preserve their potential to do so.

In future research, the scientists hope to find subtle differences between stem cells and leukemia cells that will identify treatments to block the receptors' action only in leukemia.

Other UT Southwestern researchers involved in the study from the departments of physiology and developmental biology include postdoctoral researchers Dr. ChangHao Cui, Dr. Xiaoli Chen, Dr. Chaozheng Zhang, Dr. HoangDinh Huynh, and Dr. Xunlei Kang; senior research associates Robert Silvany and Jiyuan Li; and graduate student Xuan Wan. Researchers from the department of immunology include former technician Alberto Puig Cant and Dr. E. Sally Ward, professor of immunology.

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This Week in Pathology

June 1st, 2012 5:15 am

Researchers led by Helenice Gobbi from the Federal University of Minas Gerais in Brazil report in Pathology that ALDH1 is frequently expressed in triple-negative breast cancer, and that its expression is linked to better outcome. The researchers examined the expression in ALDH1 as well as EZH2 both of which are cancer stem cell-related markers in 140 cases of triple negative breast cancer, and correlated it to clinicopathological features and disease outcome. "Our results showed that tumour cell expression of ALDH1 did not correlate with nodal status, outcome, or expression of basal markers," the researchers write. "Nonetheless, stromal expression of ALDH1 was significantly associated with better overall survival in our triple negative cohort."

Also in Pathology, the University of Western Australia's Benhur Amanuel and his colleagues examine the prevalence of BRAF p.Val600Glu and p.Val600Lys mutations in metastatic melanoma patients from an area with a high incidence of the disease. They performed dideoxy sequencing and fluorescent single-strand conformation analysis and found that the overall incidence of BRAF mutation in their cohort was similar to other studies, but that the frequency of p.Val600Lys mutations was higher. "The broad range of reported frequencies of BRAF p.Val600Glu and p.Val600Lys mutations and the observation that patients with the p.Val600Lys mutation were significantly older than those with p.Val600Glu mutation is intriguing," the researchers add. "These genetic aberrations may be linked to different tumour phenotypes, including possible association of the primary tumours with distinct precursor lesions."

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This Week in Pathology

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Stem Cell Therapy for Parkinson’s Patient.flv – Video

May 31st, 2012 7:21 pm

30-05-2012 07:23 write to:

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Stem Cell Therapy for Parkinson's Patient.flv - Video

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NeoStem to Present at Six Conferences in June

May 31st, 2012 7:21 pm

NEW YORK, May 31, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or the "Company"), an international biopharmaceutical company focused on cell based therapies, announced today that Company management will present at six conferences in June.

International Society for Cellular Therapy Annual Meeting

National Investment Banking Association Conference

International Society for Stem Cell Research 10th Annual Meeting

The Biotechnology Industry Organization (BIO) International Conference

Alliance for Regenerative Medicine -- Clinical Outlooks for Regenerative Medicine 2012

Marcum's Inaugural MicroCap Conference

About NeoStem, Inc.

NeoStem, Inc. ("NeoStem") is a leader in the development and manufacture of cell therapies. NeoStem has a strategic combination of revenues, including that which is derived from the contract manufacturing services performed by Progenitor Cell Therapy, LLC, a NeoStem company. That manufacturing base is one of the few cGMP facilities available for contracting in the burgeoning cell therapy industry, and it is the combination of PCT's core expertise in manufacturing and NeoStem's extensive research capabilities that positions the company as a leader in cell therapy development. Amorcyte, LLC, also a NeoStem company, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and is enrolling patients in a Phase 2 trial for the preservation of heart function after a heart attack. Amorcyte expects to begin a Phase 1 clinical trial in 2012/2013 for AMR-001 for the treatment of patients with congestive heart failure. Athelos Corporation, also a NeoStem company, is developing a T-cell therapy for a range of autoimmune conditions with its partner Becton-Dickinson. NeoStem's pre-clinical assets include its VSEL(TM) Technology platform for regenerative medicine, which NeoStem believes to be an endogenous, pluripotent, non-embryonic stem cell that has the potential to change the paradigm of cell therapy as we know it today.

For more information on NeoStem, please visit http://www.neostem.com.

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NeoStem to Present at Six Conferences in June

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Why Some Cancers Come Back

May 31st, 2012 4:16 pm

Researchers trace the source of recurring blood cancers to a few slowly dividing cancer stem cells.

By Cristina Luiggi | May 31, 2012

Brain cancer stem cellsWellcome Images

Why cancer comes back in some patients after chemotherapy has beaten it into remission has been a matter of debate for oncologists. In a new study published in Blood this week, researchers at The Weizmann Institute of Science in Rehovot, Israel, found that in certain blood cancers, slowly-dividing cancer stem cells that are impervious to the actions of chemotherapywhich commonly target fast-dividing cellsare the source for future recurring cancers.

Led by computational biologist Ehud Shapiro, the researchers reconstructed lineage trees of cells sampled from patients with newly diagnosed leukemia and from patients in which leukemia had returned. They found that in some cases, the source of the recurring cancer cells were not rapidly dividing cancer cells that had dodged chemotherapy, but the slowly-dividing stem cells at the root of the tree.

We know that in many cases, chemotherapy alone is not able to cure leukemia, Shapiro said in a press release. Our results suggest that to completely eliminate it, we must look for a treatment that will not only eliminate the rapidly dividing cells, but also target the cancer stem cells that are resistant to conventional treatment.

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Why Some Cancers Come Back

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Researchers identify mechanism that maintains stem cells readiness

May 31st, 2012 4:16 pm

An immune-system receptor plays an unexpected but crucially important role in keeping stem cells from differentiating and in helping blood cancer cells grow, researchers at UT Southwestern Medical Center report today in the journal Nature.

"Cancer cells grow rapidly in part because they fail to differentiate into mature cells. Drugs that induce differentiation can be used to treat cancers," said Dr. Chengcheng "Alec" Zhang, assistant professor in UT Southwestern's departments of physiology and developmental biology. "Our research identified a protein receptor on cancer cells that induces differentiation, and knowing the identity of this protein should facilitate the development of new drugs to treat cancers."

The family of proteins investigated in the study could help open a new field of biology integrating immunology with stem cell and cancer research, he added.

"The receptor we identified turned out to be a protein called a classical immune inhibitory receptor, which is known to maintain stemness of normal adult stem cells and to be important in the development of leukemia," he said.

Stemness refers to the blood stem cells' potential to develop into a range of different kinds of cells as needed, for instance to replenish red blood cells lost to bleeding or to produce more white blood cells to fight off infection. Once stem cells differentiate into adult cells, they cannot go back to being stem cells. Current thinking is that the body has a finite number of stem cells and it is best to avoid depleting them, Dr. Zhang explained.

Prior to this study, no high-affinity receptors had been identified for the family of seven proteins called the human angiopoetic-like proteins. These seven proteins are known to be involved in inflammation, supporting the activity of stem cells, breaking down fats in the blood, and growing new blood vessels to nourish tumors. Because the receptor to which these proteins bind had not been identified, the angiopoetic-like proteins were referred to as "orphans," he said.

The researchers found that the human immune-inhibitory receptor LILRB2 and a corresponding receptor on the surface of mouse cells bind to several of the angiopoetic-like proteins. Further studies, Dr. Zhang said, showed that two of the seven family members bind particularly well to the LILRB2 receptor and that binding exerts an inhibitory effect on the cell, similar to a car's brakes.

In the case of stem cells, inhibition keeps them in their stem state. They retain their potential to mature into all kinds of blood cells as needed but they don't use up their energy differentiating into mature cells. That inhibition helps stem cells maintain their potential to create new stem cells because in addition to differentiation, self-renewal is the cells' other major activity, Dr. Zhang said. He stressed that the inhibition doesn't cause them to create new stem cells but does preserve their potential to do so.

In future research, the scientists hope to find subtle differences between stem cells and leukemia cells that will identify treatments to block the receptors' action only in leukemia.

Journal reference: Nature

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Researchers identify mechanism that maintains stem cells readiness

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Researchers Identify Mechanism That Maintains Stem Cells Readiness, Helps Leukemia Cells Growth

May 31st, 2012 4:16 pm

Newswise DALLAS May 31, 2012 An immune-system receptor plays an unexpected but crucially important role in keeping stem cells from differentiating and in helping blood cancer cells grow, researchers at UT Southwestern Medical Center report today in the journal Nature.

Cancer cells grow rapidly in part because they fail to differentiate into mature cells. Drugs that induce differentiation can be used to treat cancers, said Dr. Chengcheng Alec Zhang, assistant professor in UT Southwesterns departments of physiology and developmental biology. Our research identified a protein receptor on cancer cells that induces differentiation, and knowing the identity of this protein should facilitate the development of new drugs to treat cancers.

The family of proteins investigated in the study could help open a new field of biology integrating immunology with stem cell and cancer research, he added.

The receptor we identified turned out to be a protein called a classical immune inhibitory receptor, which is known to maintain stemness of normal adult stem cells and to be important in the development of leukemia, he said.

Stemness refers to the blood stem cells potential to develop into a range of different kinds of cells as needed, for instance to replenish red blood cells lost to bleeding or to produce more white blood cells to fight off infection. Once stem cells differentiate into adult cells, they cannot go back to being stem cells. Current thinking is that the body has a finite number of stem cells and it is best to avoid depleting them, Dr. Zhang explained.

Prior to this study, no high-affinity receptors had been identified for the family of seven proteins called the human angiopoetic-like proteins. These seven proteins are known to be involved in inflammation, supporting the activity of stem cells, breaking down fats in the blood, and growing new blood vessels to nourish tumors. Because the receptor to which these proteins bind had not been identified, the angiopoetic-like proteins were referred to as orphans, he said.

The researchers found that the human immune-inhibitory receptor LILRB2 and a corresponding receptor on the surface of mouse cells bind to several of the angiopoetic-like proteins. Further studies, Dr. Zhang said, showed that two of the seven family members bind particularly well to the LILRB2 receptor and that binding exerts an inhibitory effect on the cell, similar to a cars brakes.

In the case of stem cells, inhibition keeps them in their stem state. They retain their potential to mature into all kinds of blood cells as needed but they dont use up their energy differentiating into mature cells. That inhibition helps stem cells maintain their potential to create new stem cells because in addition to differentiation, self-renewal is the cells other major activity, Dr. Zhang said. He stressed that the inhibition doesnt cause them to create new stem cells but does preserve their potential to do so.

In future research, the scientists hope to find subtle differences between stem cells and leukemia cells that will identify treatments to block the receptors action only in leukemia.

Other UT Southwestern researchers involved in the study from the departments of physiology and developmental biology include postdoctoral researchers Dr. ChangHao Cui, Dr. Xiaoli Chen, Dr. Chaozheng Zhang, Dr. HoangDinh Huynh, and Dr. Xunlei Kang; senior research associates Robert Silvany and Jiyuan Li; and graduate student Xuan Wan. Researchers from the department of immunology include former technician Alberto Puig Cant and Dr. E. Sally Ward, professor of immunology.

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Researchers Identify Mechanism That Maintains Stem Cells Readiness, Helps Leukemia Cells Growth

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Over 70,000 Orphans In China Receive Free Insurance For Severe Illnesses

May 31st, 2012 4:15 pm

Anda Berada di Sini : Dunia Berita

31 Mei, 2012 12:03 PM

Over 70,000 Orphans In China Receive Free Insurance For Severe Illnesses

BEIJING, May 31 (Bernama) -- More than 70,000 orphans in China have been given free insurance contracts that cover the costs of treating 12 critical illnesses as a joint insurance programme supported by the government and a charity organisation continues to expand.

The 12 major illnesses covered include malignant tumors, illnesses requiring organ or stem cell transplants, acute kidney failure, aplastic anemia, acute hepatitis and infantile paralysis, among others.

The most recent beneficiaries are from Beijing, Qinghai, Tianjin, Henan, Shanxi and the Guangxi Zhuang autonomous region, Xinhua news agency reported.

An insurance fund created through public donations will be accessible for one year from June 1 or Children's Day, Dr.Heidi Hu, managing director of China Children Insurance Foundation (CCIF) said Thursday.

The foundation launched the programme in collaboration with the Ministry of Civil Affairs in 2009 to provide free insurance for children of poor families and 712,000 orphans under 18.

"So far, we have distributed about 500,000 insurance contracts to children in 20 provincial regions, including the quake-hit province of Sichuan and the plateau areas of Qinghai and Tibet," said Hu.

Each insured child is covered for 100,000 yuan (about US$15,750) at a premium of 50 yuan a year.

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Over 70,000 Orphans In China Receive Free Insurance For Severe Illnesses

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