header logo image


Page 994«..1020..993994995996..1,0001,010..»

Abeona Therapeutics Receives Rare Pediatric Disease Designation … – GlobeNewswire (press release)

June 4th, 2017 12:48 am

May 30, 2017 08:05 ET | Source: Abeona Therapeutics Inc

NEW YORK and CLEVELAND, May 30, 2017 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, announced today that the FDA has granted Rare Pediatric Disease Designation for Abeonas EB-101 gene therapy program for patients with dystrophic epidermolysis bullosa (DEB), including recessive dystrophic epidermolysis bullosa (RDEB), which are life-threatening genetic skin disorders characterized by skin blisters and erosions that cover the body.

These designations are granted to drugs with high promise that may address areas of unmet medical need for children with rare diseases. RDEB is a debilitating and life threatening inherited disorder with no approved treatment options available for patients today," stated Timothy J. Miller, Ph.D., President & CEO of Abeona Therapeutics Inc. Building upon the already granted FDA and EMA Orphan Drug Disease Designations for the EB-101 gene therapy program, receiving the Rare Pediatric Disease Designation is another important validation of the science and clinical approach to developing a novel gene therapy for RDEB patients.

Typically, wounds on patients with RDEB, also known as "butterfly skin" syndrome, can remain unhealed for months to years due to the inability of the skin to stay attached to the underlying dermis and can cover a large percentage of the body. In the ongoing Phase 1/2 clinical trial, EB-101 was administered to non-healing chronic wounds on each subject and assessed for wound healing at predefined time points over years. The primary endpoints of the clinical trial assess safety and evaluate wound healing after EB-101 administration compared to control untreated wounds. Secondary endpoints include expression of collagen C7 and restoration of anchoring fibrils at three and six months post-administration.

About Rare Pediatric Disease Designation: The rare pediatric disease designation indicates that the FDA may give the company a pediatric priority review voucher if the drug is approved for the pediatric indication. That voucher could then be used by the company for another drugany drugto be given a priority review. A priority review mandates that the FDA will review a BLA drug submission within six months instead of the standard 10 months. Normally, a priority review designation would only be given to a drug that is for a serious condition and has demonstrated the potential to be a significant improvement in safety and effectiveness. The priority review voucher may be used by the sponsor, sold or transferred.

EB-101 Gene Therapy Program Highlights:

About EB-101: EB-101 is an autologous, ex-vivo gene therapy in which COL7A1 is transduced into autologous keratinocytes for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB). RDEB is a subtype of an inherited genetic skin disorder characterized by chronic skin blistering, open and painful wounds, joint contractures, esophageal strictures, pseudosyndactyly, corneal abrasions and a shortened life span. Patients with RDEB lack functional type VII collagen owing to mutations in the gene COL7A1 that encodes for C7 and is the main component of anchoring fibrils, which stabilize the dermal-epidermal basement membrane. Patients are being enrolled in the ongoing Phase 2 portion of the Phase 1/2 clinical trial (NCT01263379). The EB-101 program has also been granted orphan drug designation by the FDA and European Medicines Agency (EMA).

About Epidermolysis Bullosa (EB): EB is a group of devastating, life-threatening genetic skin disorders that is characterized by skin blisters and erosions all over the body. The most severe form, recessive dystrophic epidermolysis bullosa (RDEB), is characterized by chronic skin blistering, open and painful wounds, joint contractures, esophageal strictures, pseudosyndactyly, corneal abrasions and a shortened life span. Patients with RDEB lack functional type VII collagen (C7) owing to mutations in the gene COL7A1 that encodes for C7 and is the main component of anchoring fibrils that attach the dermis to the epidermis. EB patients suffer through intense pain throughout their lives, with no effective treatments available to reduce the severity of their symptoms. Along with the life-threatening infectious complications associated with this disorder, many individuals often develop an aggressive form of squamous cell carcinoma (SCC).

About Abeona: Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene therapies for life-threatening rare genetic diseases. Abeona's lead programs include ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA) and EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB). Abeona is also developing ABO-101 (AAV-NAGLU) for Sanfilippo syndrome type B (MPS IIIB), ABO-201 (AAV-CLN3) gene therapy for juvenile Batten disease (JNCL), ABO-202 (AAV-CLN1) for treatment of infantile Batten disease (INCL), EB-201 for epidermolysis bullosa (EB), ABO-301 (AAV-FANCC) for Fanconi anemia (FA) disorder and ABO-302 using a novel CRISPR/Cas9-based gene editing approach to gene therapy for rare blood diseases. In addition, Abeona has a plasma-based protein therapy pipeline, including SDF Alpha (alpha-1 protease inhibitor) for inherited COPD, using its proprietary SDF (Salt Diafiltration) ethanol-free process. For more information, visit http://www.abeonatherapeutics.com.

Investor Contact: Christine Silverstein Vice President, Investor Relations Abeona Therapeutics Inc. +1 (212)-786-6212 csilverstein@abeonatherapeutics.com

Media Contact: Andrea Lucca Vice President, Communications & Operations Abeona Therapeutics Inc. +1 (212)-786-6208 alucca@abeonatherapeutics.com

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, the expected receipt of a Priority Review Voucher and that involve risks and uncertainties. These statements include, without limitation, our plans for continued development and internationalization of our clinical programs, that patients will continue to be identified, enrolled, treated and monitored in the EB-101 clinical trial, and that studies will continue to indicate that EB-101 is well-tolerated and may offer significant improvements in wound healing. These statements are subject to numerous risks and uncertainties, including but not limited to continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the impact of competition; the ability to develop our products and technologies; the ability to achieve or obtain necessary regulatory approvals; the ability to secure licenses for any technology that may be necessary to commercialize our products; the impact of changes in the financial markets and global economic conditions; and other risks as may be detailed from time to time in the Company's Annual Reports on Form 10-K and other reports filed by the Company with the Securities and Exchange Commission. The Company undertakes no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Related Articles

Read this article:
Abeona Therapeutics Receives Rare Pediatric Disease Designation ... - GlobeNewswire (press release)

Read More...

Lonza buys Dutch cell and gene therapy CMO – FiercePharma

June 4th, 2017 12:48 am

Even as CDMO Lonza deals with FDA concerns about its cell manufacturing operationin the U.S., it has gone out and acquired a gene and cell contract manufacturer in Europe.

Lonza last week said it had acquired Netherlands-based PharmaCell for an undisclosed sum. It said the company had revenues of about 11 million last year. The company has a 15,500 cell manufacturing facility in Maastricht, The Netherlands, which can produce clinical through commercial-scale product.

Lonza said PharmaCell was primarily selected because of its expertise in autologous cell and gene therapy manufacturing, which includes experience with two licensedproducts in Europe.

"PharmaCells position in the market complements Lonzas leadership position in the allogeneic cell manufacturing market," Andreas Weiler, head of emerging technologies at Lonza said in a statement.

Autologous therapies use a patients own cells to create custom products as opposed to allogeneic therapies which can be manufactured in large batches from unrelated donor tissues such as bone marrow which can be used in off-the-shelf therapies. .

Loza said with this deal its gene therapy manufacturing network will span Europe, Asia and the U.S. It is Lonzas U.S. operation in the U.S. that recently ran into FDA concerns. Lonza had its cell therapy facility in Walkersville, Maryland,slapped with a warning letter in April after earlier halting some production of liquid media products being produced for a client.

The plant is overseen by the FDAs devices unit because its products are used for diagnostics. The letter said that retained samples were found to have Pantoea organisms that Lonza discovered after receiving two confirmed complaints for sterility failures of a of product.

A spokesperson said when the warning letter was issued that the company expects to have the problems resolved and FFM media manufacturing back online by mid-2017. The company had already begun a $7.6 million manufacturing upgrade at the facility, which is slated to be finished in 2018.

Originally posted here:
Lonza buys Dutch cell and gene therapy CMO - FiercePharma

Read More...

Sioux Falls Man Received Treatment Using His Own Fat Stem Cells – KDLT News (blog)

June 4th, 2017 12:47 am

SIOUX FALLS, S.D. Doctors say a breakthrough in stem cell research from over a decade ago could someday replace traditional medicine. A procedure using a patients own fat stem cells has already helped many people across the world, but these types of procedures havent been approved in the U.S. Thats why one Sioux Falls man and some Sanford doctors traveled to Munich, Germany last year.

Imagine a more natural way of treating pain or even a more advanced treatment for cancer. What if I told you common ailments like chronic back pain or arthritis could be healed? Thats what doctors say treatments using a patients own stem cells could do. One of those doctors is German Doctor Eckhard Alt.

The next generation of medicine would be to learn how we can heal ourselves, without artificial implants, without drugs, that we use the regenerative power of our own body, said Dr. Alt.

This might sound like something out of a Sci-Fi movie, but Dr. Alt says this type of practice is already being brought to clinical practice.

In nature, tells you there is a regenerative potential in all of us. If you look at the lizard, you cut off the tail, it even has the ability to re-grow, said Dr. Alt

Doctors say many patients have chronic pain and have exhausted all of their options. Thats what happened to one Sioux Falls man, Bill Marlette. He lost one of his arms in an accident when he was a teenager, resulting in more stress on his other wrist. Marlette said the excessive stress on his wrist caused a lot of pain, even when doing everyday activities. When his doctor heard about Dr. Alts practices, he suggested the procedure using his own fat stem cells. Last year, Marlette traveled to Munich, Germany with some Sanford Doctors to repair his wrist.

Its made my life more active and pain free again, said Sanford Health Treasurer, Bill Marlette.

Marlette said he hopes the national exposure from his story can help Sanfords goal of bringing treatments like this to the region. He said the procedure has been life changing for him and could benefit many other patients.

Without this I, I would be probably really scaling back in what I could do, said Marlette.

Marlette said 2 weeks after the procedure pain had already started to go away. Now, 7 months later he said hes pain free.

See original here:
Sioux Falls Man Received Treatment Using His Own Fat Stem Cells - KDLT News (blog)

Read More...

Stem Cells Fast Facts – KABC

June 4th, 2017 12:47 am

(CNN) Here is some background information about stem cells.

Scientists believe that stem cell research can be used to treat medical conditions including Parkinsons disease, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis and rheumatoid arthritis.

About Stem Cells:Stem cell research focuses on embryonic stem cells and adult stem cells.

Stem cells have two characteristics that differentiate them from other types of cells:- Stem cells are unspecialized cells that replicate themselves for long periods through cell division.- Under certain physiologic or experimental conditions, stem cells can be induced to become mature cells with special functions such as the beating cells of the heart muscle or insulin-producing cells of the pancreas.

There are four classes of stem cells: totipotent, multipotent, pluripotent, and unipotent.- Totipotent stem cells that develop into cells that make up all the cells in an embryo and fetus. (Ex: The zygote/fertilized egg and the cells at the very early stages following fertilization are considered totipotent)- Multipotent stem cells can give rise to multiple types of cells, but all within a particular tissue, organ, or physiological system. (Ex: blood-forming stem cells/bone marrow cells, most often referred to as adult stem cells)- Pluripotent stem cells (ex: embryonic stem cells) can give rise to any type of cell in the body. These cells are like blank slates, and they have the potential to turn into any type of cell.- Unipotent stem cells can self-renew as well as give rise to a single mature cell type. (Ex: sperm producing cells)

Embryonic stem cells are harvested from four to six-day-old embryos. These embryos are either leftover embryos in fertility clinics or embryos created specifically for harvesting stem cells by therapeutic cloning. Only South Korean scientists claim to have successfully created human embryos via therapeutic cloning and have harvested stem cells from them.

Adult stem cells are already designated for a certain organ or tissue. Some adult stem cells can be coaxed into or be reprogrammed into turning into a different type of specialized cell within the tissue type for example, a heart stem cell can give rise to a functional heart muscle cell, but it is still unclear whether they can give rise to all different cell types of the body.

The primary role of adult stem cells is to maintain and repair the tissue in which they are found.

Uses of Stem Cell Research:Regenerative (reparative) medicine uses cell-based therapies to treat disease.

Scientists who research stem cells are trying to identify how undifferentiated stem cells become differentiated as serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation.

Scientists believe stem cells can be used to generate cells and tissues that could be used for cell-based therapies as the need for donated organs and tissues outweighs the supply.

Stem cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases, including Parkinsons and Alzheimers diseases, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.

Policy Debate:Cloning human embryos for stem cells is very controversial.

The goal of therapeutic cloning research is not to make babies, but to make embryonic stem cells, which can be harvested and used for cell-based therapies.

Using fertilized eggs left over at fertility clinics is also controversial because removing the stem cells destroys them.

Questions of ethics arise because embryos are destroyed as the cells are extracted, such as: When does human life begin? What is the moral status of the human embryo?

Timeline:1998 President Bill Clinton requests a National Bioethics Advisory Commission to study the question of stem cell research.

1999 The National Bioethics Advisory Commission recommends that the government allow federal funds to be used to support research on human embryonic stem cells.

2000 During his campaign, George W. Bush says he opposes any research that involves the destruction of embryos.

2000 The National Institutes of Health (NIH) issues guidelines for the use of embryonic stem cells in research, specifying that scientists receiving federal funds can use only extra embryos that would otherwise be discarded. President Clinton approves federal funding for stem cell research but Congress does not fund it.

August 9, 2001 President Bush announces he will allow federal funding for about 60 existing stem cell lines created before this date.

January 18, 2002 A panel of experts at the National Academy of Sciences (NAS) recommends a complete ban on human reproductive cloning, but supports so-called therapeutic cloning for medical purposes.

February 27, 2002 For the second time in two years, the House passes a ban on all cloning of human embryos.

July 11, 2002 The Presidents Council on Bioethics recommends a four-year ban on cloning for medical research to allow time for debate.

February 2005 South Korean scientist Hwang Woo Suk publishes a study in Science announcing he has successfully created stem cell lines using therapeutic cloning.

December 2005 Experts from Seoul National University Hwang of faking some of his research. Hwang asks to have his paper withdrawn while his work is being investigated and resigns his post.

January 10, 2006 An investigative panel from Seoul National University accuses Hwang of faking his research.

July 18, 2006 The Senate votes 63-37 to loosen President Bushs limits on federal funding for embryonic stem-cell research.

July 19, 2006 President Bush vetoes the embryonic stem-cell research bill passed by the Senate (the Stem Cell Research Enhancement Act of 2005), his first veto since taking office.

June 20, 2007 President Bush vetoes the Stem Cell Research Enhancement Act of 2007, his third veto of his presidency.

January 23, 2009 The FDA approves a request from Geron Corp. to test embryonic stem cells on eight to 10 patients with severe spinal cord injuries. This will be the worlds first test in humans of a therapy derived from human embryonic stem cells. The tests will use stem cells cultured from embryos left over in fertility clinics.

March 9, 2009 President Barack Obama signs an executive order overturning an order signed by President Bush in August 2001 that barred the NIH from funding research on embryonic stem cells beyond using 60 cell lines that existed at that time.

August 23, 2010 US District Judge Royce C. Lamberth issues a preliminary injunction that prohibits the federal funding of embryonic stem cell research.

September 9, 2010 A three-judge panel of the US Court of Appeals for the D.C. Circuit grants a request from the Justice Department to lift a temporary injunction that blocked federal funding of stem cell research.

September 28, 2010 The US Court of Appeals for the District of Columbia Circuit lifts an injunction imposed by a federal judge, thereby allowing federally funded embryonic stem-cell research to continue while the Obama Administration appeals the judges original ruling against use of public funds in such research.

October 8, 2010 The first human is injected with cells from human embryonic stem cells in a clinical trial sponsored by Geron Corp.

November 22, 2010 William Caldwell, CEO of Advanced Cell Technology, tells CNN that the FDA has granted approval for his company to start a clinical trial using cells grown from human embryonic stem cells. The treatment will be for an inherited degenerative eye disease.

April 29, 2011 The US Court of Appeals for the District of Columbia lifts an injunction, imposed last year by a federal judge, banning the Obama administration from funding embryonic stem-cell research.

May 11, 2011 Stem cell therapy in sports medicine is spotlighted after New York Yankee pitcher Bartolo Colon is revealed to have had fat and bone marrow stem cells injected into his injured elbow and shoulder while in the Dominican Republic.

July 27, 2011 Judge Lamberth dismisses a lawsuit that tried to block funding of stem cell research on human embryos.

February 13, 2012 Early research published by scientists at Cedars-Sinai Medical Center and Johns Hopkins University show that a patients own stem cells can be used to regenerate heart tissue and help undo damage caused by a heart attack. It is the first instance of therapeutic regeneration.

May 2013 Scientists make the first embryonic stem cell from human skin cells by reprogramming human skin cells back to their embryonic state, according to a study published in the journal, Cell.

April 2014 For the first time scientists are able to use cloning technologies to generate stem cells that are genetically matched to adult patients,according to a study published in the journal, Cell Stem Cell.

October 2014 Researchers say that human embryonic stem cells have restored the sight of several nearly blind patients and that their latest study shows the cells are safe to use long-term. According to a report published in The Lancet, the researchers transplanted stem cells into 18 patients with severe vision loss as a result of two types of macular degeneration.

Click here to read full story

Read more here:
Stem Cells Fast Facts - KABC

Read More...

Hundreds walk at N. Raleigh park to fight blindness – News & Observer (blog)

June 4th, 2017 12:47 am

News & Observer (blog)
Hundreds walk at N. Raleigh park to fight blindness
News & Observer (blog)
At age 8, Tyler Kirk started losing his eyesight to Stargardt disease, and he battled through Raleigh public schools learning Braille, guided by a white cane and tenacity. A quarter-century later, he works as a securities lawyer in Washington, D.C ...

Read more:
Hundreds walk at N. Raleigh park to fight blindness - News & Observer (blog)

Read More...

Opening Eyes and heavy hearts – Central Michigan Life

June 4th, 2017 12:47 am

Tears began glistening in Meredith Tonigish's eyes as she pointed out"Dr. Phil 2017" written on more than 100volunteers' shirts among eye screening stations in the end zone of the Indoor Athletic Complex.

Over the last 17 years,more than 13,000 eye exams have been performed and 7,000 pairs of glasses have been given to Special Olympics Michigan athletes all because of Dr. Philip Irion's vision.

Dr. Philip Irion

The optometrist from Lansingwas instrumental in bringing the first-ever Opening Eyes program to the 2000 SOMI Summer Games, where he and a group of volunteers performed 663 vision tests and gave out 172 pairs of glasses in just three days. Following a brief illness, Irion passed away in March.This year's SOMI Summer Games were dedicated to his memory.

"It's been rough," Tongish said. "The reason we all come out and do this for these athletes is because (Irion) made it happen. He was like thefather to this big Opening Eyes family we have."

Opening Eyes is one of the services provided in SOMI's athlete village during the summer games. At the village,SOMI athletes canreceive services provided by volunteer health professionals at no cost to the athletes and their families. More than 900 athletes received free eye exams thisweekend during the 2017 SOMI Summer Games.

Athletes go through 13 stations where they can receivenear and far sight exams, color exams and fitting for glasses if they need them. Medical volunteers conduct the exams and make the glasses on sight with donated lenses and frames.

Irion was inspired to bring Opening Eyes to Michigan after seeing it at the World Games in 1999. What started out in a small classroom at CMU now covers an entire end zone in the Indoor Athletic Complex's Turf Bay.

Many athletesreceive their first pairs of glasses through Opening Eyes program, said SOMI Chief Program Officer Ann Guzdzial. Free vision care, designer sunglasses and prescription swim goggles are also available to the athletes.

"Many of our athletes can't afford these types of services," Guzdzial said. "I remember one year a little girl ran up and said, 'I can see the bottom of the pool for the first time.'"

In addition to free eye exams, the healthy athlete village also provided dental care and other preliminary examinations to SOMI athletes.

Read the original here:
Opening Eyes and heavy hearts - Central Michigan Life

Read More...

Community members turn out in droves to Walk for Sight, raise awareness for visually impaired – Concord Monitor

June 4th, 2017 12:47 am

Kelly Spain-Kelly and her daughter Delaney walked out onto Walker Street from Future in Sight headquarters Saturday morning.

The mother and daughter were among 500 walkers, clad blue T-shirts, taking part in the nonprofits 14th annual 3k Walk for Sight, an event which raises money and awareness for the visually impaired.

For Spain-Kelly, who works for Future in Sight, and Delaney, who is visually impaired, the walk was especially meaningful.

(Delaney) has a brain tumor, it is inoperable she has a good prognosis for longevity but she is going to more than likely lose all of her vision because of the tumor, Spain-Kelly said.

Spain-Kelly works at the nonprofit as an orientation mobility specialist, helping the blind and visually impaired learn how to navigate in their environments safely and independently. It was Delaneys diagnosis and her experience receiving help from Future in Sight that motivated her to look into the field and go back to school for it.

I called them to find out about programs for my daughter and the person I talked to actually told me about the field and so I did research and went back and got my masters degree, Spain-Kelly said. Based on that, and because of my daughter, I ended up getting hired here when I graduated.

Spain-Kelly came to Future in Sight at a time of change for the organization, formerly known as the New Hampshire Association for the Blind, president and CEO David Morgan said.

Not only has the organizations name changed its also expanded the number of people it serves, with 2,200 covered across the state, Morgan said.

The money raised at the walk is crucial for supporting its expanded services, he said.

The funds raised today will really be to support those programs and the more walkers we have, the more folks that engage, the more likely we are to expand, he said. Because even after serving 2,200 folks this year there are still 28,000 plus over the state and two thirds of them are seniors and many of them will be living alone without access to services.

Among the participants in the race was Glen Booth of Loudon.

Booth, 78, was a fifth year participant in the event, but was walking with his great granddaughter for the first time this year.

Its going to be great, shes carrying one sign, Im carrying the other, he said. I have lazy eye blindness and I know what visually impaired people are going through because of it.

Randy Pierce, the chairman of Future in Sight, told Saturdays crowd that people that were visually impaired should be empowered to live whatever lives they wanted.

I dont have sight I hope the lesson you have, that all of us have learned, is that if your sight is impaired, your vision doesnt have to be impaired, he said, addressing the walkers. Your future can have a beautiful vision if you just look at the world differently.

Spain-Kelly echoed Pierce, saying Delaney was living as normal a life as possible.

She is a spunky little girl and is always happy and positive and really never complains about the treatments, she said.

Read this article:
Community members turn out in droves to Walk for Sight, raise awareness for visually impaired - Concord Monitor

Read More...

Ask a Doc: At risk for diabetes? Simple lifestyle changes could save your life – AZCentral.com

June 4th, 2017 12:47 am

Dr. Tiffany Pankow, Special for The Republic | azcentral.com 7:00 a.m. MT June 2, 2017

Dr. Tiffany Pankow(Photo: HonorHealth)

Question: What can I do to prevent becoming diabetic?

Answer: More than one in three Americans has prediabetes, and 90 percent of them dont know it.

With prediabetes, your blood sugar levels are impaired but arent high enough to be diagnosed as diabetes. Because most people dont have symptoms, it can go undetected without screening.

Unfortunately, many with this condition will develop diabetes within a short time if the condition isnt addressed.

If you have prediabetes, youre at increased risk for heart disease and stroke. If diabetes develops, add blindness, kidney failure, and loss of limb from amputation to the risk list.

The good news is that you often can prevent diabetes with healthy lifestyle modifications, education, and sometimes, medication.

Identifying the early stages of glucose impairment before diabetes develops is an important way to reverse and prevent chronic disease.

If you have one or more of the following risk factors, talk to your doctor about screening for prediabetes with a blood test:

If you have prediabetes or are at risk for developing diabetes, several lifestyle changes can greatly decrease your risk. Although making lifestyle changes can be challenging, even small adjustments can have lasting results:

Losing 5-7 percent of your body weight can prevent or delay the progression to diabetes.

Replacing processed and packaged food with vegetables, fruits and lean protein such as chicken, fish, and turkey improves nutrition and decreases calories.

Avoiding white flour in pasta, pastries and bagels and instead choosing whole-grain options for carbohydrates can improve blood sugar levels.

Increasing exercise to a goal of 150 minutes per week and getting enough restful sleep can also help lower glucose levels and prevent diabetes.

Managing stress is another important component of a healthy lifestyle.

Limiting added sugar in foods to 25 grams (6 teaspoons) a day for women and 37.5 grams (9 teaspoons) for men is an American Heart Association recommendation.

For more information or to find a doctor to help you with screening or treatment for prediabetes, visit honorhealth.com/medical-services/primary-care.

Tiffany Pankow, MD, specializes in family medicine with HonorHealth Medical Group. She can be reached at 480-882-7360 or visit https://www.honorhealth.com/physicians/tiffany-pankow

More Ask a Doc:

Can a hacker tinker with my ticker?

First psychotic episode? Seek early treatment

When large brain vessels shrink

This could be why your heel is hurting

Read or Share this story: http://azc.cc/2rN2Ui4

See the original post:
Ask a Doc: At risk for diabetes? Simple lifestyle changes could save your life - AZCentral.com

Read More...

Gastric Bypass Surgery May Be Best Bet for Diabetes – NBC 5 Dallas-Fort Worth

June 4th, 2017 12:47 am

Diabetes can be deadly. Each year, more than 70,000 Americans die from complications of the disease. About half of all people with Type 2 diabetes don't have their condition under control.

New research now confirms a well-known procedure for weight loss may be the best bet for patients with uncontrolled diabetes.

Lisa Shaffer, at her heaviest, weighed nearly 300 pounds.

"When I was obese, my life was so limited," Shaffer said.

Her health suffered, too. Lisa had Type 2 diabetes, and she tried everything to control it.

"Nothing worked, nope," Shaffer explained.

But today she is 120 pounds lighter and her diabetes is gone. The reason: gastric bypass surgery.

"It's been incredible. Yeah, it really did give me my life back," Shaffer said.

Dr. Phillip Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute, led a study that compared bariatric surgery, either gastric bypass or gastric sleeve, to intense medical therapy in people with diabetes. After five years, the gastric bypass patients did the best. Many were in complete remission without drugs or insulin.

"Which is pretty remarkable. That's about as close to a cure that you can get," Schauer said.

Twenty-nine percent of gastric bypass and 23 percent of gastric sleeve patients achieved and maintained normal blood sugar levels, compared to just 5 percent of medication-only patients. The surgery groups also lost more weight and reported a better quality of life.

"All in all, the patients who had surgery did better and were happier at the five- year mark," Schauer said.

Three days after her surgery, Shaffer was off all of her meds. Her A1c, a measure of blood sugar control, was 10.5 before the surgery and today, it's 5.3. Now she's able to live the life she's always wanted.

"Ever since I lost the weight, I've run three 5Ks. I've done zip-lining with the family, which is fantastic. Just no limits anymore, there's no limitations on my life anymore," Shaffer said.

Schauer says weight loss is one reason diabetes patients benefit from bariatric surgery. The other is something that happens in the body as a result of the surgery. When the intestines are bypassed, special hormones increase, which helps the pancreas produce insulin more effectively.

Published at 4:48 PM CDT on Jun 2, 2017 | Updated at 4:55 PM CDT on Jun 2, 2017

Read more from the original source:
Gastric Bypass Surgery May Be Best Bet for Diabetes - NBC 5 Dallas-Fort Worth

Read More...

DC’s Real Estate Community Raises $525K For Diabetes Research At 28th Games – Bisnow

June 4th, 2017 12:47 am

More than2,000 D.C.-area real estate professionals packed into American University Thursday for a day of athletic competitionfor a good cause.

Bisnow: Jon Banister

Award winners and organizers of the 28th JDRF Real Estate Games

The 28th JDRF Real Estate Games raised a record $525K for Type 1 diabetes research, beating last year's total of $520K.

Awards were handed out to those who helped put the games together. Grosvenor Americas' Zac Linsky won the Steve Lauble award for his work as logistics chair. Cushman & Wakefield's Summer Newman won the Pete Wysocki Award for her work as volunteer chair. Bozzuto's Manny Egoegonwa won the Sherry Cushman award for co-chairing the games for the second year in a row, alongside Savills Studley'sSarah Dreyer.

Bisnow: Jon Banister

Brookfield's Dave Bevirt, JBG's Jill Goubeaux and Savills Studley's Adam Singer

JBG's Jill Goubeaux served as the honorary chair for the second straight year. Goubeaux,Egoegonwa and Dreyer became the first two-year leadership team in the games' history to raise over $1M for Type 1 diabetes. As she handed the torch to Brookfield's Dave Bevirt, who will serve as next year's honorary chair, Goubeauxoffered a challenge to her successor.

"Can you beat it?" she asked him.

Bisnow: Jon Banister

Clark Construction defeating HITT in the final round of the tug-of-war tournament.

From 8 a.m. to 4 p.m., teams of real estate companies competed in aseries of athletic competitions that required strength, speed, precision and a sense of humor.

The points were tallied and Clark Construction won first place for the 10th consecutiveyear. Savills Studleycame in second and Turner Construction placed third. In the final event, a tug-of-war tournament, Clark defeated last year's tug-of-war winner, HITT Contracting.

Bisnow: Jon Banister

Members of Donohoe and COPT competing in the Allsteel chair relay.

Teams competed in some unconventional contests, like racing backward in a chair around the school's outdoor track. Teams of four competed in a relay with each person pushing themselves around a quarter of the track before handing off the chair.

Bisnow: Jon Banister

A member of the Willco team running the obstacle course.

Speaking of unconventional, competitors inthe outdoor relay race wore a viking helmet and poncho. They had to run through uphill tires before tiptoeingacross a balance beam while dodging water balloons, crossing a few moreobstacles before ultimately coming back down the hill by way of aslip and slide.

Bisnow: Jon Banister

Cohn Reznick (white) defeated Harvey Cleary (black) 9-8 in this basketball game.

Players also competed in some traditional sporting events like basketball, volleyball, wrestling, tennis, golf and swimming. A tournament of half-court, 3-on-3 basketball games occupied one of the courts in Bender Arena for half of the day, before the court was changed to volleyball.

Bisnow: Jon Banister

Clark Construction's Jim Calvo winning the heads of office relay.

While younger professionalsmade up mostof the teams, company executives competed in the head of office relay before a crowd of their employees.

The office heads had to put on a tutu and construction gear before drilling a screw into a piece of wood and finished by sliding across the gym headfirst on afour-wheeled cart. Clark Construction's Jim Calvo won the race.

Bisnow: Jon Banister

Signs at the Real Estate Games showed local children diagnosed with Type 1 diabetes.

The real estate teamsspent the day trying to beat their competition, but thegames' founder, Savills Studley's Adam Singer, emphasized that everyone is coming together to help people battling diabetes. He added a new installation at this year's event: a series of signs showing local children who have been diagnosed with Type 1 diabetes.

"We wanted to remind everyone why we're here," Singer said.

Read more:
DC's Real Estate Community Raises $525K For Diabetes Research At 28th Games - Bisnow

Read More...

Diabetes specialists seek to push WIC program away from juice – Harvard Gazette

June 4th, 2017 12:47 am

Harvard Gazette
Diabetes specialists seek to push WIC program away from juice
Harvard Gazette
The article was written by Harvard Medical School Assistant Professor Florence Brown, director of the Joslin-Beth Israel Deaconess Diabetes and Pregnancy Program; HMS instructor in pediatrics Elvira Isganaitis, a research associate and staff ...

Here is the original post:
Diabetes specialists seek to push WIC program away from juice - Harvard Gazette

Read More...

BioEden – Autistic Children’s Early Success Stories From Tooth Stem Cells – PR Newswire (press release)

June 4th, 2017 12:46 am

- More and more people retrieve their banked cells and benefit from clinical treatments

Twenty individuals, ranging from the ages of 2 to 43, have become the first to use stem cells from their teeth in the treatment of various conditions including cerebral palsy, diabetes, cleft lip, and autism. The cells in use are dental pulp stem cells (DPSCs) - the richest source of MSCs in the body - extracted from the likes of exfoliated incisors, deciduous or baby, and wisdom teeth.

All patients report no adverse reactions, with several experiencing huge improvements in their conditions. To date, all treatments worked as well if not better than traditional treatments, but by far the most promising results are being seen in children with autism.

A complex behavioural disorder that affects 1 in every 100 people in the UK, autism is one of the biggest challenges that faces modern medicine today. Not only do symptoms manifest differently in each patient, but there is no one definitive cause. To treat an individual requires a tailored combination of therapies and medications - often meaning years of harsh drugs and hours of intensive behavioural therapy.

Many experts believe stem cell therapy can change that, or at least help children along the way, and several recent studies are proving their intentions are more than good-hearted. Their case is based on the rationale that autism is caused, in part, by inflammation in the body. And a particular type of stem cells, known as mesenchymal stem cells (MSCs), is able to reduce that inflammation.

Our teeth are not only richer in MSCs than bone marrow or cord blood, but the process of extraction also costs less and can be done so non-invasively, using naturally fallen teeth. This makes it an easy and completely pain-free process. You don't even have to see the inside of a hospital or clinic - just send the tooth to the bank, and they will do the rest.

And that's exactly what the parents of five children with autism did. Having originally sent teeth of all shapes and sizes to BioEden, the world's first tooth stem cell bank, they've now retrieved their cells and the children are involved in various stages of cell-based therapies.

Reports from one 11-year-old show how developmental markers across the board improved after just 10 weeks of treatment. Progress has been made in language, driving motility, communication with the environment, and memory and retention, and they're getting ready for their second round of treatment this year.

In another case of an 11-year-old, the child didn't speak before the treatment but now has a vocabulary of 15 words. Other improvements among the five children include better memory, mobility, and bodily control, more energy, a new sensitivity to pain, and physical growth. It's clear autism responds well to tooth cells.

Tooth stem cell banking offers patients a convenient and risk-free alternative to cord blood banking for example and bone marrow aspiration. By not throwing away those shedded baby teeth and instead sending them to a specialist tooth bank, you can arm yourself with a powerful resource and help safeguard a children's future health.

BioEden is a specialist banking facility that does not directly participate in or encourage its customers to seek therapies. The determination as to whether stem cell therapy may be useful to treat a particular condition is a decision that must be made between the patient and their treating physician.

Contact: Leon Staff Tel.: +44-208-4770-336 Email: info@bioeden.co.uk

Website: http://www.bioeden.com

SOURCE BioEden

Read the original:
BioEden - Autistic Children's Early Success Stories From Tooth Stem Cells - PR Newswire (press release)

Read More...

Journal Highlight: Proteomics applications in dental derived stem cells – separationsNOW.com

June 4th, 2017 12:46 am

Skip to Navigation

Proteomics applications in dental derived stem cells

Journal of Cellular Physiology, 2017, 232, 1602-1610 Jie Li, Weidong Tian and Jinlin Song

Abstract: At present, the existence of a variety of dental derived stem cells has been documented. These cells displayed promising clinical application potential not only for teeth and its surrounding tissue regeneration, but also for other tissues, such as nerve and bone regeneration. Proteomics is an unbiased, global informatics tool that provides information on all protein expression levels as well as post-translational modification in cells or tissues and is applicable to dental derived stem cells research. Over the last decade, considerable progress has been made to study the global proteome, secrotome, and membrane proteome of dental derived stem cells. Here, we present an overview of the proteomics studies in the context of stem cell research. Particular attention is given to dental derived stem cell types as well as current challenges and opportunities.

Follow us on Twitter!

Follow this link:
Journal Highlight: Proteomics applications in dental derived stem cells - separationsNOW.com

Read More...

Stem Cell Therapies Market Assessment And … – | MENAFN.COM – MENAFN.COM

June 4th, 2017 12:46 am

(MENAFN Editorial) Stem cells are characterized by their potential to develop into fully functional cells of a specific organ or tissue in the body. Theoretically stem cells can be artificially coaxed into becoming a muscular cell, nerve cell or any other based on the medical requirement. This capability called Totipotency is sometimes lost along the development stages and cells then become pluripotent, multi-potent and oligopotent at each level. The stem cells of the body include embryonic stem cells, which are present in a blastocyst, fetal stem cells, cord blood stem cells (isolated from umbilical cord), adipose tissue, hematopoietic stem cells and dental stem cells. Stem cells and progenitor cells help act as a treatment and can perform as a damage repair mechanism of the body. Umbilical stem cells and embryonic stem cells can be stored in cryogenic-refrigeration as a stem cell storage bank for later use.

Stem cells have been applied in several therapies of late, particularly in oncology and brain disorders. The potential areas of stem cell therapy are limitless since the stem cells adapt to various body stimulus to convert into cells of unique function and type. This report covers the market for stem cell therapies, products and anti-bodies among other products in research pipelines of many key industrial players. The most common type of cells therapies commercialized today includes mesenchymal stem cells or MSCs. SCs used in osteo-grafting is one of the fastest growing market segments today. Research & development is carried out by government and private institutions on a very large scale since the success of even one application would mean the quickest means of treating severe and debilitating diseases and conditions. The most common proven treatments are targeted for bone, corneal and skin diseases. AMD in particular is a key target area within corneal treatments. BMT?s have been performed for over a decade successfully in most cases for autoimmune disorders, cancer and blood disorders among others. A rising application area is cosmetics wherein conditions such as alopecia are considered as strong growth factors.

Request Free Report Sample@ http://www.sa-brc.com/Global-Stem-Cell-Therapies-Market-Assessment--Forecast-2017-2021/up36

Ongoing research by SA-BRC estates suggest the market to be valued at US 6.5 billion in 2014 and growing at a CAGR of 16.8%. The major drivers of this therapy are the increase in the stem cell banking and cord blood banking market, which has increased the number of stem cell procedures. The stem cell banking market is thus complementing the stem cell therapy market. Another factor driving the growth is the list of potential applications. Several challenges are currently preventing the use of stem cells particularly in western countries, where intense regulatory hurdles have resulted in the slow progress in treatment approvals unlike countries such as China, where stem cell therapies have received a greater acceptance by the government and are practiced on a larger scope of therapies. Reimbursement and cost of treatment is expected to be one of the most significant challenges to this market since ethical issues as well cost incurred to hospital for technology used to complete all stages of stem cell therapies. Since several therapies are not covered for by insurance, out-of-pocket expenses are enormous in most experimental cases.

Stem cell therapy is relatively an old research area in biopharmaceutical and biotechnology. There are an estimated 2 million research projects covering all aspects of stem cell research over the world. There are over 400 clinical trials being conducted across the world for SC therapy products. Thus, there are numerous players involved in stem cell products of which the most notable key players are companies such as Cytori, Cardio3 Bioscience, Bioheart, Aastrom Biosciences, Invitrogen (part of Life Technologies), Osiris Therapeutics, TiGenix and Gamida Cell. The competitive landscape is highly fragmented and is expected to remain so due to high number of emerging players in the market leading to a high level of threat from new entrants.

Request For TOC@ http://www.sa-brc.com/Global-Stem-Cell-Therapies-Market-Assessment--Forecast-2016---2020/upcomingdetail36

NOTE: This report is currently under research and will be made available to clients on request. For more information, visit: http://www.sa-brc.com/Global-Stem-Cell-Therapies-Market-Assessment--Forecast-2016---2020/upcomingdetail36

MENAFN0306201700703262ID1095531520

Excerpt from:
Stem Cell Therapies Market Assessment And ... - | MENAFN.COM - MENAFN.COM

Read More...

Mice headed for space to test bone-building drug – Medical Xpress

June 4th, 2017 12:46 am

June 2, 2017 by Mirabai Vogt-James A bone densitometer will accompany the mice to the space station. It measures the bone density of the animals. Credit: University of California, Los Angeles

What do space travel, rodents and a bone-building protein all have in common? A team of UCLA scientists is bringing these three elements together to test an experimental drug that could one day result in a treatment for osteoporosis, which affects more than 200 million people worldwide.

The drug could also potentially help those with bone damage or loss, a condition that afflicts people with traumatic bone injury, such as injured military service members, as well as astronauts who lose bone density while in space.

Led by Dr. Chia Soo and Dr. Kang Ting, who met and married while working on this project, as well as Dr. Ben Wu, the UCLA research team is scheduled to send 40 rodents to the International Space Station this week. Once there, the rodents will receive injections of the experimental drug, which is based on a bone-building protein called NELL-1. The project is being done in collaboration with NASA and the Center for the Advancement of Science in Space, which manages the U.S. National Laboratory on the space station.

"This is really a pivotal point in the study of NELL-1's effect on bone density," said Soo, principal investigator on the study, the vice chair for research in the UCLA Division of Plastic and Reconstructive Surgery, and a member of the UCLA Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research. "We would not be at this point without many years of funding and support from the National Institutes of Health, the California Institute for Regenerative Medicine and several UCLA departments and centers. We are honored to conduct the next phase of our research in the U.S. National Laboratory."

The video will load shortly

The UCLA researchers have been conducting studies on NELL-1 for more than 18 years and were excited when Julie Robinson, NASA's chief scientist for the International Space Station Program, visited UCLA in early 2014 and encouraged them to submit a grant that would fund their NELL-1 research in space. The team received the necessary funding from the Center for the Advancement of Science in Space in September 2014 to move forward with the project.

"The preparations have been very exciting; we've had conference calls with NASA's Ames Research Center every two weeks to go over all the fine details," said Dr. Jin Hee Kwak, an assistant professor of orthodontics in the UCLA School of Dentistry and project manager on the study. "Everything is choreographed down to the tiniest details, such as whether you're going to fill a syringe half way or all the waythat small amount affects the total weight of the rocket."

SpaceX's Dragon spacecraft is currently targeted to blast off from Kennedy Space Center in Florida today. It will be the first time that UCLA scientists send rodents to the International Space Station. After living in microgravity and receiving NELL-1 injections for about four weeks, half of the rodents will return from space and land in the Pacific Ocean off the coast of Baja, California.

This marks the first time that American researchers will bring back live rodents from the International Space Station. After retrieval, the rodents will be returned to UCLA where they will continue to receive the NELL-1 drug for an additional four weeks. The remaining half of the rodents that stay in the space station will also receive an additional four-week dosage of the drug and will return to UCLA later.

"To prepare for the space project and eventual clinical use, we chemically modified NELL-1 to stay active longer," said Wu, who is chair of the division of advanced prosthodontics in the UCLA School of Dentistry and professor in the schools of engineering and medicine. "We also engineered the NELL-1 protein with a special molecule that binds to bone, so the molecule directs NELL-1 to its correct target, similar to how a homing device directs a missile."

Discovered in 1996 by Ting, NELL-1 has a powerful effect on tissue-specific stem cells that create bone-building cells called osteoblasts. When exposed to NELL-1, the stem cells create osteoblasts that are much more effective at building bone. Furthermore, NELL-1 reduces the function of osteoclasts, which are the cells that break down bone.

"Our preclinical studies show that NELL-1's dual effect on both osteoblasts and osteoclasts significantly increases bone density," said Ting, chair of the section of orthodontics and the division of growth and development in the UCLA School of Dentistry.

After the age of 50, humans typically lose about 0.5 percent of their bone mass each year. But in space, bone loss significantly increases due to the lack of gravity. It is commonly known that bone density is improved by physical activity that puts pressure on bone, which helps it stay strong. Without gravity's pressure, astronauts can lose around 1.5 percent of their bone mass each month. Therefore, space is an ideal testing environment for NELL-1's effect on bone density.

Research on NELL-1 is supported by past or current grants from the National Institute of Dental and Craniofacial Research, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the California Institute for Regenerative Medicine, the UCLA Broad Stem Cell Research Center, the UCLA School of Dentistry, the UCLA Department of Orthopaedic Surgery and the UCLA Orthopaedic Hospital Research Center.

The experimental NELL-1 drug described above is used in preclinical tests only and has not been tested in humans or approved by the Food and Drug Administration as safe and effective for use in humans.

Explore further: Study reveals bone-building protein's impact on bone stem cells

A new study by UCLA researchers shows that administering the protein NELL-1 intravenously stimulates significant bone formation through the regenerative ability of stem cells.

Growing bone on demand sounds like a space-age concepta potentially life changing one. Such a capability could benefit those needing bone for reconstructive surgery due to trauma like combat injuries or those waging a ...

A UCLA research team has found a combination of proteins that could significantly improve clinical bone restoration. The findings may be a big step toward developing effective therapeutic treatments for bone skeletal defects, ...

UCLA stem cell scientists purified a subset of stem cells found in fat tissue and made from them bone that was formed faster and was of higher quality than bone grown using traditional methods, a finding that may one day ...

Bone morphogenetic protein-2 (BMP2) is used clinically to promote bone repair. However, the high BMP2 concentrations required to stimulate bone growth in humans may produce life-threatening adverse effects such as cervical ...

Researchers from the UCLA Department of Medicine, Division of Hematology Oncology and the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have published two studies that define how key ...

When it gets cold around you, your body turns up the heat to maintain its normal temperature. The heat is produced by brown adipose tissue, or brown fat, which also plays a role in how the body uses glucose and fat. However, ...

A University of California, Berkeley, study of mice reveals, for the first time, how puberty hormones might impede some aspects of flexible youthful learning.

A detour on the road to regenerative medicine for people with muscular disorders is figuring out how to coax muscle stem cells to fuse together and form functioning skeletal muscle tissues. A study published June 1 by Nature ...

The bacteria in a child's gut appears to be influenced as early as its first year by ethnicity and breastfeeding, according to a new study from McMaster University.

Cholesterol, a naturally occurring compound at the lung surface, has been shown to have a clear effect on the properties of this nanoscale film that covers the inside of our lungs. Cholesterol levels in this system may affect ...

Researchers from Monash University have developed a new drug delivery strategy able to block pain within the nerve cells, in what could be a major development of an immediate and long lasting treatment for pain.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Originally posted here:
Mice headed for space to test bone-building drug - Medical Xpress

Read More...

‘Glaucoma is symptomless, leads to blindness in few yrs’ | Indore … – Times of India

June 4th, 2017 12:45 am

INDORE: Glaucoma is major cause of eye related problem but due to lack of awareness, around 90 per cent patients fail to get timely treatment, says an expert during a two-day conference- Ophthalmology Tomorrow- that started on Saturday.

"Glaucoma, also known as eye pressure, is a symptomless disease and therefore, people are unable to approach the doctors at early stage. This lead to permanent blindness within a few years" said the oration award winner Dr G Chandrasekhar of Hyderabad.

People with over 40 years of age suffering from diabetes and have family history of glaucoma are at high risk to catch the disease. Thus, they should go for eye check-up at regular intervals of 1-2 years. "We have technology to operate cataract by placing lenses in eyes without administrating drops of anaesthesia. There is only a need to create awareness among people about comprehensive check-up from eye-specialist for glaucoma," said Dr Chandrasekhar.

Excerpt from:
'Glaucoma is symptomless, leads to blindness in few yrs' | Indore ... - Times of India

Read More...

Puma Biotechnology Announces Positive PB272 Phase II Data from TBCRC 022 Trial in Patients with HER2-Positive … – Business Wire (press release)

June 4th, 2017 12:45 am

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced the presentation of positive results from an ongoing Phase II clinical trial (Translational Breast Cancer Research Consortium TBCRC 022) of Puma's investigational drug PB272 (neratinib) for the treatment of HER2-positive metastatic breast cancer that has metastasized to the brain. The data were presented today in an oral presentation at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting in Chicago, Illinois.

The multicenter Phase II clinical trial enrolled patients with HER2-positive metastatic breast cancer who have brain metastases. The trial is being performed by the TBCRC and enrolled three cohorts of patients. Patients in the first cohort (n=40) included those with progressive brain metastases who were administered neratinib monotherapy. Data from this cohort were previously reported at the 2014 ASCO Annual Meeting and published in the Journal of Clinical Oncology in 2016. Patients in the second cohort (n=5) represent patients who had brain metastases which were amenable to surgery and who were administered neratinib monotherapy prior to and after surgical resection. The third cohort (target enrollment=60) enrolled two sub-groups of patients (prior lapatinib-treated and no prior lapatinib) with progressive brain metastases who were administered neratinib in combination with the chemotherapy drug capecitabine. The oral presentation reflects only the patients in the third cohort of patients without prior lapatinib exposure (cohort 3A, n=37), who all had progressive brain metastases at the time of enrollment and who received the combination of capecitabine plus neratinib. A full copy of the oral presentation that was presented at the ASCO Annual Meeting is available on the Puma Biotechnology website. Results from the second cohort and cohort 3B (prior lapatinib-treated) will be presented at a forthcoming medical meeting.

In cohort 3A, 30% of the patients had received prior craniotomy, 65% of the patients had received prior whole brain radiotherapy (WBRT), and 35% had received prior stereotactic radiosurgery (SRS) to the brain. No patients had received prior treatment with lapatinib.

The primary endpoint of the trial was central nervous system (CNS) Objective Response Rate according to a composite criteria that included volumetric brain MRI measurements, steroid use, neurological signs and symptoms, and RECIST evaluation for non-CNS sites. The secondary endpoint of the trial was CNS response by Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) Criteria. The efficacy results from the trial showed that 49% of patients experienced a CNS Objective Response by the composite criteria. The results also showed that the CNS response rate using the RANO-BM criteria was 24%. The median time to CNS progression was 5.5 months and the median overall survival was 13.5 months, though 49% of patients remain alive and survival data are immature.

The results for cohort 3A showed that the most frequently observed severe adverse event for the 37 patients evaluable for safety was diarrhea. Patients received antidiarrheal prophylaxis consisting of high dose loperamide, given together with the combination of capecitabine plus neratinib for the first cycle of treatment in order to try to reduce the neratinib-related diarrhea. Among the 37 patients evaluable for safety, 32% of the patients had grade 3 diarrhea and 41% had grade 2 diarrhea.

Neratinib given in combination with capecitabine showed promising activity in patients with heavily pre-treated HER2-positive disease metastatic to the CNS, said Rachel A. Freedman, MD, MPH, Breast Oncology Center, Susan F. Smith Center for Women's Cancers, Dana-Farber Cancer Institute. Despite the introduction of several new treatments for patients with HER2-positive metastatic breast cancer, CNS progression events remain a major source of patient morbidity and mortality. Based on the results from TBCRC-022, we look forward to additional trials with neratinib-based regimens for HER2-positive CNS disease.

We are very pleased with the activity seen in this trial with the combination of neratinib plus capecitabine, said Alan H. Auerbach, CEO and President of Puma Biotechnology. As a small molecule that can cross the blood brain barrier, neratinib potentially offers patients with HER2-positive metastatic breast cancer that has metastasized to the CNS a novel HER2 targeted treatment option. We look forward to working with TBCRC on future trials of neratinib in patients with HER2-positive disease metastatic to the CNS.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidatesPB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the development and potential benefits of the Companys drug candidates, the Companys clinical trials and the announcement of data relative to these trials. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company's dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company's drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company's products, the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, risks pertaining to securities class action, derivative and defamation lawsuits, the Company's dependence on licensed intellectual property, and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

Follow this link:
Puma Biotechnology Announces Positive PB272 Phase II Data from TBCRC 022 Trial in Patients with HER2-Positive ... - Business Wire (press release)

Read More...

Bsc Biotechnology What Does The Course Cover? – Good Herald

June 4th, 2017 12:45 am

If you are interested in a career in one of the most interesting areas of science then you should consider joining the field of biotechnology. Armed with a BSc Biotechnology degree, you will be able to apply for many interesting and high paying jobs across a number of industries. As a matter of fact, there are quite a few colleges in Dehradun that offer three year graduate programs in biotechnology because there is a great deal of demand for a degree in this field on account of its robust job prospects. Keep in mind that youll generally need to have a background in science (10 + 2) in order to be able to apply for this course because math, biology and chemistry are very important to students in this field.

The field of biotechnology is growing at a very rapid pace and it is also essential to many industries. The importance of this field comes from its ability to use technological methodologies to improve a number of biological systems in order to create new processes and products that have the ability to improve our life overall. The field of biotechnology consists of many different areas of study. Some of the most important ones are Immunology, Molecular Biology, Genetic Engineering, Microbiology and Environmental Biotechnology, just to name a few. Plant and animal biotechnology are also important areas of study.

Since the field of biotechnology is a very vast one that covers many different areas of study, it is best for you to understand which area appeals to you the best before you select a particular program. It is also important to keep in mind that the employment opportunities offered by each area of study differ considerably. Even so, you will find that employment opportunities for a BSc biotechnology graduate are fairly robust.

If you have a BSc Biotechnology degree then you will be able to get employment right away although a Masters degree will brighten your job prospects further. As a graduate, you will be able to get jobs in various fields including chemicals, pharmaceuticals, food processing and agriculture. The government is a very good source of jobs for biotechnologists and so are many large corporate houses. Waste management is a very important area these days and there is great need for biotechnologists who specialize in this area. As you can see, biotechnology is a very large and important field that is worth entering.

For more information on B.Sc Biotechnology. Visit Today http://bfitdoon.com/bsc-biotechnology.php

Photo By OpenClipart-Vectors from Pixabay

See the original post:
Bsc Biotechnology What Does The Course Cover? - Good Herald

Read More...

Evolving Biotechnology – Good Herald

June 4th, 2017 12:45 am

There are plenty of explanations of what biotechnology is, but the simplest one is that it is a field of study where biology is the foundation on which different kinds of technology are developed. Biotechnology is the basis of many different kinds of research in the fields of environment, food science, robotics, agriculture and medicine.

The human involvement in manipulating their environment is now at remarkable levels. From the most basic direct organism manipulations such as fermenting beer and culturing bacteria to advanced nucleotide-based organ regeneration and animal cloning, our knowledge and technology has advanced far beyond what anyone wouldve expected just a decade ago.

But even before there was a name to call it by, biotechnology was in existence. Even something that people have been doing for centuries, like preservatives to keep food edible during winter, is a form of biotechnology. When around 6000 BC, fruit juice was first fermented to form alcohol, it was another instance of biotechnology. Of course, it has emerged as a science only recently.

About twenty years ago, the role of genetics in artificially creating proteins in a living being was discovered. DNA was discovered and molecular biology became a part of mainstream science. This was what gave rise to the study of biotechnology under that name.

The mid 80s brought a revelation in biotechnology genetic structures could be modified by careful combinations between animals and plants. This introduction to transgenic organisms also developed an area for further research into disease resistance and productivity rate increases. Modern biotechnology is used in a variety of ways and the medical and biological research fields have managed to get the most benefit out of it. The methods used have gone beyond ordinary genetic transfers, to include actual plant-generated pharmaceuticals and substance production for antibiotics and insulin.

Modern biotechnology is practiced in three different categories red, white and green. Red Biotechnology is when the genetically altered microorganisms are used to produce medical and pharmaceutical substances, such as proteins, vitamins, antibiotics and vaccines etc. Its also used in genome manipulation.

White Biotechnology is also known as bio-manufacturing and Grey Biotechnology. This is not yet a completely established field and involves manipulating live organisms to create important industrial chemicals. Some of the organisms used in these techniques include bacteria, enzymes, moulds and yeast.

Agricultural Biotechnology, also known as Green Biotechnology, is whats applied into creating better, fresher, more nutritious and longer-lasting agricultural produce. A traditional agricultural biotechnology example is how wheat varieties are cross-bred to produce a disease-resistant crop.

If you are looking for the latest biotech news then take a look at this great new website. Full of details about innovations for the biotech industry , you cant afford to miss it. New inventions, ideas and theories make great reading.

Photo By 3dman_eu from Pixabay

See the original post here:
Evolving Biotechnology - Good Herald

Read More...

Scientists Hope to Use Stem Cells to Reverse Death in Controversial Study – Futurism

June 3rd, 2017 9:44 am

In BriefBioquark is about to begin a trial that will attempt to bringbrain-dead patients back to life using stem cells. However, thetrial is raising numerous scientific and ethical questions forother experts in the field. Back From The Dead

Researchers seem to be setting their sights on increasinglylofty goals when it comes to the human body from the worlds first human head transplant, to fighting aging, and now reversing death altogether. Yes, you read that right. A company called Bioquarkhopes to bring people who have been declared clinically brain-dead back to life. The Philadelphia-based biotech company is expected to start on the project later this year.

This trial was originally intended to go forward in 2016 in India, but regulators shut it down. Assuming this plan will be substantially similar, it will enroll 20 patients who will undergo various treatments. The stem cell injection will come first, with the stem cells isolated from that patients own blood or fat. Next, the protein blend gets injected directly into the spinal cord, which is intended to foster growth of new neurons. The laser therapy and nerve stimulation follow for 15 days, with the aim of prompting the neurons to make connections. Meanwhile, the researchers will monitor both behavior and EEGs for any signs of the treatment causing any changes.

While there is some basis in science for each step in the process, the entire regimen is under major scrutiny. The electrical stimulation of the median nerve has been tested, but most evidence exists in the form of case studies. Dr. Ed Cooper has described dozens of these cases, and indicates that the technique can have some limited success in some patients in comas. However, comas and brain death are very different, and Bioquarks process raises more questions for most researchers than it answers.

One issue researchers are raising about this study is informed consent. How can participants in the trial consent, and how should researchers complete their trial paperwork given that the participants are legally dead and how can brain death be conclusively confirmed, anyway? What would happen if any brain activity did return, and what would the patients mental state be? Could anything beyond extreme brain damage even be possible?

As reported by Stat News, In 2016, neurologist Dr. Ariane Lewis and bioethicist Arthur Caplan wrote in Critical Care that the trial is dubious, has no scientific foundation, and suffers from an at best, ethically questionable, and at worst, outright unethical nature. According to Stat News, despite his earlier work with electrical stimulation of the median nerve, Dr. Cooper also doubts Bioquarks method, and feels there is no way this technique could work on someone who is brain-dead. The technique, he said, relies on there being a functional brain stem one of the structures that most motor neurons go through before connecting with the cortex proper. If theres no functional brain stem, then it cant work.

Pediatric surgeon Charles Cox, who is not involved in Bioquarks work, agrees with Cooper, commenting to Stat News on Bioquarks full protocol, its not the absolute craziest thing Ive ever heard, but I think the probability of that working is next to zero. I think [someone reviving] would technically be a miracle.

Pastor remains optimistic about Bioquarks protocol. I give us a pretty good chance, he said. I just think its a matter of putting it all together and getting the right people and the right minds on it.

See the original post here:
Scientists Hope to Use Stem Cells to Reverse Death in Controversial Study - Futurism

Read More...

Page 994«..1020..993994995996..1,0001,010..»


2025 © StemCell Therapy is proudly powered by WordPress
Entries (RSS) Comments (RSS) | Violinesth by Patrick