|BioTime Submits Protocol for Initiation of Renevia™; Eli Lilly settles Pregnancy Drug-Cancer Case|
|By Staff and Wire Reports|
|Thursday, 10 January 2013 20:02|
BioTime, Inc. (NYSE: BTX), a biotechnology company which develops and markets products in the field of regenerative medicine, announced it has submitted a Clinical Investigation Protocol (CIP) to European regulatory authorities for approval to initiate studies for its Renevia" stem cell delivery platform. The Principal Investigator for the studies will be Ramon Llull, MD, and the planned trials will be conducted at the Stem Center, Palma de Mallorca, Spain (www.stem-center.com). The Stem Center is operated by the GID Group, Inc., of Louisville, Colorado. BioTime (BTIM-RETIRED) is currently completing the production of clinical materials according to current Good Manufacturing Practice regulations. The initiation of human clinical studies is expected in Q2 of this year upon approval of the CIP.
Renevia™, a member of the Companys HyStem® family of hydrogels, is a proprietary formulation that mimics the human extracellular matrix, a web of molecules surrounding cells that is essential to cellular function. Renevia" is designed to be a liquid injectable matrix capable of safely polymerizing in the body into a three-dimensional tissue-like scaffold in combination with transplanted cells. Anchoring the transplanted cells in such a biocompatible matrix generally increases the percentage of viable cell engraftment. HyStem® hydrogels are currently being used by researchers at a number of leading medical schools in laboratory studies to investigate a broad array of stem cell therapies, including wound healing, treatment of ischemic stroke, brain cancer, vocal fold scarring, and cardiac infarct.
This is an important step forward in our commercialization efforts and brings us closer to delivering this much-needed matrix technology for the emerging field of regenerative medicine, stated William P. Tew, PhD, Chief Commercialization Officer of BioTime, Inc. The technology forms a foundation for the delivery of cell-based therapeutic products in both the adult and embryonic stem cell marketplace. Current preclinical studies at leading medical institutions have shown that HyStem® hydrogels are compatible with a wide variety of tissue types including brain, bone, skin, nerve, cartilage, and heart.
In the clinical application described in this CIP, Renevia" will be used as a delivery matrix for autologous adipose cells in order to restore subcutaneous tissue lost as a result of injury, oncologic resection, or congenital defects. Restoration of the normal skin contour is an important quality-of-life issue, not only in elective cosmetic procedures, but also in reconstructive surgeries needed to repair deformities and traumatic injuries to the face and upper extremities. BioTimes plan is to bring Renevia" to the medical market first in the European Union, where the regulatory pathway will allow for faster approval. Once the use of Renevia" is established in Europe, BioTime plans to address an even larger potential market in the United States.
Eli Lilly and Co. (NYSE:LLY) has settled a lawsuit brought by four sisters who contended their breast cancer was caused by a drug their mother took during pregnancy in the 1950s, a move some believe could trigger financial settlements in scores of other claims brought by women around the country.
A total of 51 women, including the Melnick sisters, filed lawsuits in Boston against more than a dozen companies that made or marketed a synthetic estrogen known as DES.
The Melnick sisters' case was the first to go to trial. The settlement was announced Wednesday on the second day of testimony.
DES, or diethylstilbestrol, was prescribed to millions of pregnant women over three decades to prevent miscarriages, premature births and other problems. It was taken off the market in the early 1970s after it was linked to a rare vaginal cancer in women whose mothers used it. Studies later showed the drug didn't prevent miscarriages.
Attorney Aaron Levine, representing the Melnick sisters, told the jury during opening statements that Eli Lilly failed to test the drug's effect on fetuses before promoting it as a way to prevent miscarriages.
Lawyer James Dillon, for Indianapolis-based Eli Lilly, told the jury that there was no evidence the drug causes breast cancer in the daughters of women who took it.
Dillon also said that no medical records show that the mother of the Melnick sisters took DES or that, if she did take it, it was made by Eli Lilly. Leading researchers at the time recommended that DES be used for pregnant women who had consecutive miscarriages, he said.
DES was not patented and was made by many companies.
Boston attorney Andrew Meyer, who's handled numerous medical malpractice cases, said the settlement in this case could signal settlements in other cases.
"When one settles a case, they recognize they can lose it," he said. "The reason they can lose it is because there's enough evidence for the plaintiffs to be able to win it. So it's not just optics, it isn't."
Columbus, Ohio, resident Irene Sawyer also is suing Eli Lilly, alleging that her prenatal exposure to DES caused her breast cancer. She called the settlement "a huge victory" for DES daughters.
"The bottom line is that this company put out a drug without testing, without knowing the consequences of this drug," she said.
It's wonderful, she said, that drug companies "are starting to realize this is not right, that there are consequences."
The Melnick sisters, who grew up in Tresckow, Pa., said they all developed breast cancer in their 40s.
Levine told the jury that their mother did not take DES while pregnant with a fifth sister and that sister has not developed breast cancer.
The four Melnick sisters also had miscarriages, fertility problems or other reproductive tract problems long suspected of being caused by prenatal exposure to DES. They were diagnosed with breast cancer between 1997 and 2003 and had treatments ranging from lump-removal surgery to a full mastectomy, radiation and chemotherapy.
Thousands of lawsuits have been filed alleging links between DES and vaginal cancer, cervical cancer and fertility problems. Many of those cases were settled.
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BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced it has submitted a Clinical Investigation Protocol (CIP) to European regulatory authorities for approval to initiate studies for its Renevia™ stem cell delivery platform.
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