The Gamida Cell-Teva Joint Venture Concludes Enrollment for the Phase III Study of StemEx®, a Cord Blood Stem Cell …

JERUSALEM--(BUSINESS WIRE)--

Gamida Cell announced today that the Gamida Cell-Teva Joint Venture (JV), equally held by Gamida Cell and Teva Pharmaceutical Industries, has enrolled the last of 100 patients in the international, multi-center, pivotal registration, Phase III clinical trial of StemEx, a cell therapy product in development as an alternative therapeutic treatment for adolescents and adults, with blood cancers such as leukemia and lymphoma, who cannot find a family related, matched bone marrow donor.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell, said, "The JV is planning to announce the safety and efficacy results of the Phase III StemEx trial in 2012 and to launch the product into the market in 2013. It is our hope that StemEx will provide the answer for the thousands of leukemia and lymphoma patients unable to find a matched, related bone marrow donor.”

Dr. Margolin continued, “StemEx may be the first allogeneic cell therapy to be brought to market. This is a source of pride for Gamida Cell, as it further confirms the company’s leadership as a pioneer in cell therapy. In addition to StemEx, Gamida Cell is developing a diverse pipeline of products for the treatment of cancer, hematological diseases such as sickle cell disease and thalassemia, as well as autoimmune and metabolic diseases and conditions helped by regenerative medicine.”

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The company’s pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers such as leukemia and lymphoma, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cell’s therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, which are expanded in culture. Gamida Cell was successful in translating these proprietary expansion technologies into robust and validated manufacturing processes under GMP. Gamida Cell’s current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: http://www.gamida-cell.com.

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The Gamida Cell-Teva Joint Venture Concludes Enrollment for the Phase III Study of StemEx®, a Cord Blood Stem Cell ...

Therapy targets leukemia stem cells

Public release date: 13-Feb-2012
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Contact: Lisa Lyons
elyons@cell.com
617-386-2121
Cell Press

New research takes aim at stubborn cancer stem cells that are thought to be responsible for treatment resistance and relapse. The study, published by Cell Press in the February 14 issue of the journal Cancer Cell, provides insight into mechanisms associated with the survival of leukemia stem cells and identifies a potential therapeutic target that is specific for these dangerously persistent cells.

Chronic myelogenous leukemia (CML) is a cancer of the white blood cells for which tyrosine kinase inhibitors are currently the first line of therapy. These drugs prolong survival, but disease recurrence is often seen after drug treatment is stopped. "Tyrosine kinase inhibitors do not eliminate leukemia stem cells, which remain a potential source of cancer recurrence," explains senior coauthor Dr. Ravi Bhatia from the City of Hope National Medical Center in Duarte, California. "CML patients need to take tyrosine kinase inhibitor treatment indefinitely, which carries a significant risk of toxicity, lack of compliance, drug resistance, relapse, and associated expense."

Strategies targeting leukemia stem cells are necessary to achieve a cure. Previous work has implicated the enzyme sirtuin 1 (SIRT1) in protecting stem cells from stress and in playing a role in leukemia, as well as other types of cancer. In the current study, Dr. Bhatia, coauthor Dr. WenYong Chen, first author Ling Li, and their colleagues investigated whether SIRT1 was involved in the survival and growth of CML stem cells. The researchers discovered that SIRT1 was overexpressed in CML stem cells and that inhibition of SIRT1selectively reduced the survival and growth of CML stem cells. Importantly, SIRT1 inhibition was associated with activation of the p53 tumor suppressor.

Taken together, the results reveal a specific mechanism that supports the survival of leukemia stem cells. "Our findings are important because they show that SIRT1-mediated inactivation of p53 contributes to CML leukemia stem cell survival and resistance to treatment with tyrosine kinase inhibitors," concludes Dr. Chen. "We suggest that SIRT1 inhibition is an attractive approach to selectively target leukemia stem cells that resist elimination by current treatments."

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Therapy targets leukemia stem cells

Stem cell treatments change girl's life

PIEDMONT, Okla. -- Stem cell research is one of the newest and most exciting areas of study. Experts believe these tiny unwritten cells hold the keys to curing a number of diseases and debilitating injuries. But here in the U.S., stem cell research isn't moving fast enough for a growing number of families.

This is the story of an Oklahoma family that traveled to China for cutting-edge stem cell treatment not offered in the US.

Cora Beth Taylor walks a different road than most will ever travel.

Her journey is filled with obstacles, heartbreak and triumph.

Cora, William and Tate Taylor are triplets born premature.

The brothers have never shown any signs of prematurity.

But Cora, at about a year old, started falling behind developmentally.

By 18 months she had been diagnosed with Cerebral Palsy.

Cora has never had any cognitive delays.

She's a super-smart little gal but her muscles haven't developed properly.

It's devastating; they just won't cooperate.

Cora's parents, Kevin and Beth Taylor, have tried everything for their little girl; that is, everything available in the U.S.

Last year, Piedmont Schools raised the money to help the Taylors take Cora to China for treatment, close to $50,000.

Research hospitals in China are using stem cells from donor umbilical cord blood to treat children with Cerebral Palsy.

Beth Taylor says, "That was a difficult decision to make to take your child to a foreign country for medical treatments. Living in the US you feel like this is the best there is."

The Taylors spent 37 days in China.

Cora Beth had eight stem cell transfusions.

Through a spinal tap, doctors put the cells into her spinal column where they penetrate the blood-brain barrier and get to work.

Critics are quick to point out this area of regenerative medicine has largely unverified effectiveness. Results are often anecdotal and the FDA is a long way from approving this type of experimental treatment for America.

Though the Taylors are convinced and here's why.

Beth Taylor said, "Within the first couple of weeks we could see changes. We could see definite improvements in strength and balance."

Cora had never been able to do a sit-up in her life ever; she did her first in China.

Nine-year-old Cora remembers, "The thing that I was most happy about accomplishing was a sit up. Because I'd tried to do a sit up before going to China but I just couldn't do it."

Now, Cora Beth can do 20.

The most notable change has been Cora's walk.

This third-grader had never gone to school without her walker.

Today she walks the halls without it; she hasn't used it in months.

She recently competed in a beauty pageant in her hometown of Piedmont, without the help of her walker as well.

Cora says, "So, I'm really excited. I don't think there's anything that I couldn't accomplish."

Doctors say Cora’s stem cells will continue to mature over the next few years.

For her, there are many milestones ahead.

In the US, Duke University is studying stem cell treatments for children with Cerebral Palsy.

Right now they don't have FDA clearance to use donor stem-cells.

Experts say treatment similar to Cora Beth's Chinese therapy is years away in the U.S.

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Stem cell treatments change girl's life