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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: David Bogdanoff who wrote (13309)	1/14/1998 12:22:00 PM
From: bob zagorin	Respond to of 32384

As long as the subject has turned to prostate, i would like to hear some informed comments on Genta's prostate trials as detailed below. Skip the nasty comments about MM etc. We all know GNTA is the worst performing stock of all time. But there are some very knowledgable people on this thread. Genta Announces Initiation of Phase I/IIa Prostate Cancer Trial At Memorial Sloan-Kettering Cancer Center G3139 Compound Begins First U.S. Trial SAN DIEGO--(BUSINESS WIRE)--Dec. 3, 1997-- Genta Incorporated (Nasdaq: GNTA - news) announced today that it has initiated a U.S. Phase I/IIa clinical trial at Memorial Sloan-Kettering Cancer Center (MSKCC) to evaluate G3139, a lead compound of Genta's Anticode(TM) technology, against prostate cancer. Prostate cancer is the most common form of cancer among men-the American Cancer Society estimates that more than 330,000 new cases and 41,000 deaths will occur in the U.S. in 1997. The first part of the Phase I/IIa study at MSKCC is designed to define the maximum tolerated dose (MTD) or optimal biological dose with continuous intravenous infusion; the second part is to determine the efficacy of the drug in advanced, androgen independent prostate cancer. Patient recruitment is under way at MSKCC in New York City and enrollment is expected to proceed in the near future. A European Phase I/IIa trial utilizing G3139 against non-Hodgkin's lymphoma is nearing completion. Genta's Anticode(TM) Compounds: Genetic Control of Disease Cells in the human body produce, or ''express,'' tens of thousands of proteins which are essential for life. Many human diseases arise when cells over-express certain normal proteins as a result of inherited or acquired genetic defects. Anticode (antisense) compounds are short, synthetic strands of DNA that halt this disease-causing process by binding with a specific messenger ribonucleic acid (mRNA), preventing the over-expression of its protein. The target of G3139 -- the BCL2 gene -- has been implicated in prostate cancer, non-Hodgkin's lymphoma, melanoma, breast and other cancers. BCL2 is a proto-oncogene (a gene associated with malignancy) that acts as a major inhibitor of apoptosis (programmed cell death) of cancerous cells. The protein produced by this gene has two known critical functions in the progression of cancer-it makes cancer cells immortal, creating a survival advantage for malignant over normal cells and confers resistance to radiation and chemotherapy, rendering these treatments ineffective in the late stages of many types of cancers. G3139 is designed to inactivate the RNA that produces the BCL2 protein product, thereby preventing cellular production of the protein. Howard I. Scher, M.D., the trial's principal investigator and Chief of the Genitourinary Oncology Service at the Memorial Sloan-Kettering Cancer Center, commented, ''We are very pleased to be collaborating with Genta on this exciting antisense technology. It is our hope that this trial will lead to further development of the technology and result in improved clinical outcomes for our patients.'' Kenneth G. Kasses, Ph.D., President and CEO of Genta, stated, ''The initiation of a U.S. trial for G3139 at Memorial Sloan-Kettering is a major milestone for Genta. The MSKCC study is the first in a series of trials that we plan to begin over the next year at prestigious institutions in North America to study the safety and efficacy of G3139 in different cancers.'' European Phase I/IIa Non-Hodgkin's Lymphoma Trial in Final Stage A Phase I/IIa study of G3139 in non-Hodgkin's lymphoma at the Royal Marsden Hospital in London is currently in its final stage to confirm MTD by continuous subcutaneous infusion. While this study is designed primarily as a safety study, biological activity of G3139 has been seen in seven patients of the seventeen enrolled, including one complete response. Treatment of three patients was discontinued as MTD was established. One patient experienced hypotension and thrombocytopenia which resolved by discontinuing treatment, and no adverse effects were noted when the patient was retreated at a lower dose.