�Geron Corporation (Nasdaq: GERN) announced the enrollment of the first base patient in a clinical trial of its telomerase inhibitor dose, GRN163L, in locally repeated or metastatic breast cancer.
The main objective of the Phase I/II, dosage escalation written report is to determine the safety, maximum tolerated back breaker (MTD) and objective response rate of GRN163L when administered intravenously in combination with a paclitaxel/bevacizumab regime in this patient population.
"We ar excited to have enrolled the first patient in this study," said Kathy D. Miller, M.D., Associate Director for Clinical Research at the Indiana University Melvin and Bren Simon Cancer Center and lead investigator of the test. "We let anticipated the clinical rating of this drug in breast crab based on promising preclinical studies."
"This is an important milestone in the clinical development of our lead antitumour drug," said Fabio Benedetti, M.D., Geron's chief medical officer, oncology. "Extending the clinical testing of GRN163L to breast cancer reflects the potentially broad and important function of telomerase in fighting cancer."
The current study is the fifth clinical trial of GRN163L. Studies are ongoing at 14 other U.S. medical centers in patients with chronic lymphoproliferative diseases, multiple myeloma, non-small mobile phone lung malignant neoplastic disease, and other solid tumour malignancies administering GRN163L as either a single agent or in combination with conventional treatments. More info about these trials can be institute in the Patient Information section of Geron's site at hTTP://www.geron.com or on the NIH clinical trials register at hTTP://www.clinicaltrials.gov (search "GRN163L").
About Breast Cancer
Breast cancer is the most often diagnosed cancer the Crab in women, with an estimated incidence in the United States of more than clxxx,000 new cases and over 40,000 deaths this year. In addition, about 2,000 cases of chest cancer ar expected to occur in men, account statement for 1% of all new breast cancers.
A regimen of paclitaxel and bevacizumab is a current standard handling for metastatic breast malignant neoplastic disease. Paclitaxel is an anti-mitotic agent put-upon as a standard chemotherapy drug. Bevacizumab is a monoclonal antibody against vascular endothelial emergence factor (VEGF) used in combination with standard chemotherapy for the treatment of multiple metastatic cancers.
About Telomerase and GRN163L
Telomerase is a critical and potentially broadly applicable tumor target. The enzyme is expressed in a wide range of malignant tumors, and its activity is essential for the indefinite replicative mental ability of cancer cells that enables their malignant emergence. Telomerase is absent or expressed only transiently at low levels in nearly normal grownup tissues.
GRN163L is a short strand oligonucleotide that binds with very high affinity and specificity to the catalytic site of telomerase, resulting in competitive inhibition of enzyme activity. Proprietary manufacture chemistry and 5' lipoid chain were developed to improve the molecule's ability to penetrate cells and tissues.
GRN163L has demonstrated preclinical antitumor effects in a spacious range of hematological and solid tumour models, including breast cancer.
Geron is a biopharmaceutical company that is developing first-in-class therapeutic products for the treatment of malignant neoplastic disease and chronic degenerative diseases, including spinal anesthesia cord injury, heart failure and diabetes. The products are based on our core expertness in telomerase and human embryonic stem cells. For more information, visit hypertext transfer protocol://www.geron.com.
This news handout may stop forward-looking statements made pursuant to the "safe harbour" provisions of the Private Securities Litigation Reform Act of 1995. Investors ar cautioned that statements in this press release regarding potential applications of Geron's telomerase engineering science constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the ontogeny and commercialisation of potency products, precariousness of clinical trial results or regulative approvals or clearances, motivation for future capital, dependance upon collaborators and criminal maintenance of our intellectual property rights. Actual results may differ materially from the results awaited in these forward-looking statements. Additional information on potential difference factors that could affect our results and early risks and uncertainties ar detailed from time to time in Geron's occasional reports, including the every quarter report on Form 10-Q for the quarter over June 30, 2008.
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