Dr. Thomas Okarma Resumes Direct Leadership of Geron's Oncology Drug Development Activities
Jan 25, 2008 07:30:01 (ET)
MENLO PARK, Calif., Jan 25, 2008 (BUSINESS WIRE) -- Geron Corporation (GERN, Trade ) today announced that President and Chief Executive Officer Thomas B. Okarma, Ph.D., M.D., has resumed his operational leadership of the company's oncology drug development activities. In this role he replaces Alan Colowick, M.D., M.P.H., who is leaving the company to pursue other interests. Geron also announced the appointment of Dr. Fabio Benedetti as Chief Medical Officer, Oncology.
In 2007, Geron expanded the development program for its telomerase inhibitor drug, GRN163L, to four clinical trials in patients with chronic lymphocytic leukemia (CLL), solid tumor malignancies, non-small cell lung cancer and multiple myeloma at 15 medical centers in the United States. In addition, Geron built on positive data obtained in previous studies to initiate a Phase II clinical trial of its telomerase cancer vaccine, GRNVAC1, in patients with acute myelogenous leukemia. Over the year, Geron also established a strong, multidisciplinary product development organization that includes clinical development, clinical operations, biostatistics, PKDM, and program management functions to successfully execute its oncology program plans.
"We've made significant progress in increasing the breadth of our clinical program and in expanding the capabilities of the oncology team, now headed by Dr. Fabio Benedetti, Geron's chief medical officer for oncology," said Dr. Okarma. "We're currently in the fifth dosing cohort for the GRN163L CLL and solid tumor trials and we expect to conclude these studies knowing the dosing regimen appropriate for future Phase II trials. We also plan to initiate combination studies of GRN163L with standard of care chemotherapy in breast cancer and multiple myeloma. If the data are positive in the ongoing GRN163L single agent study in multiple myeloma, we plan to pursue a pivotal registration trial in that indication. With GRNVAC1, we're now dosing patients and are excited about the potential of the prime-boost regimen that extends the duration of telomerase immunity. We appreciate Alan's contributions in helping build our oncology team and programs during this eventful year."
Dr. Colowick added, "Geron is well-positioned with its in-house oncology team to move GRN163L and GRNVAC1 forward through the development process. In my view, both therapeutic products have blockbuster potential. I am happy to have played a role in the expansion of what are very promising programs. I made the difficult decision to leave Geron because I have been presented with the opportunity to be CEO of a late-stage private company."
About GRN163L
GRN163L is a short chain oligonucleotide that is unique in its resistance to nuclease digestion in blood and tissues and in its very high affinity and specificity for telomerase. The molecule has superior cellular and tissue penetration properties due to its proprietary manufacturing chemistry and its 5' lipid chain. GRN163L has been demonstrated to have anti-tumor effects in a wide range of hematological and solid tumor pre-clinical models and appears to be unique in its observed effects on cancer stem cells: the rare chemotherapy-resistant cancer cells that may cause cancer recurrence.
About GRNVAC1
GRNVAC1 is an immunotherapeutic product made from autologous dendritic cells transfected with mRNA encoding telomerase protein and the lysosomal targeting signal, lysosome-associated membrane protein (LAMP). This autologous product is designed to induce cellular immune responses to telomerase, an antigen highly expressed in the nucleus of cancer cells and found on their surface but not expressed in most normal cells. Unlike other tumor targets, hTERT, the protein component of telomerase, is essential for maintaining the proliferative capacity and survival of the majority of tumor cell types.
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