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

To: Lyn Benson who wrote (29885)	1/5/2000 10:30:00 AM
From: bob zagorin	Read Replies (1) \| Respond to of 32384

off-topic but Taxol related. NCI Commences Trial of Genta's Bcl-2 Antisense Compound Combined With Paclitaxel for Relapsed Small Cell Lung Cancer LEXINGTON, Mass., Jan. 5 /PRNewswire/ -- Genta Incorporated (Nasdaq: GNTA) today announced that the National Cancer Institute (NCI) commenced a Phase 1-2 study of Genta's lead anticancer compound, G3139, at the University of Chicago Medical Center and Ohio State University Hospital. The study will use G3139 in combination with paclitaxel (Taxol(R), Bristol Myers Squibb) for the treatment of relapsed small lung cell cancer. About 25% of all lung cancers are the small cell type. While chemotherapy very often produces initial responses, the disease commonly relapses in less than a year. Following relapse, the available treatment options for patients are limited. The study is being conducted under the previously announced Cooperative Research and Development Agreement (CRADA) between Genta and the NCI. The goal of the Genta-NCI collaboration is to provide new treatment options for patients with specific cancer indications and ultimately to obtain regulatory approval of G3139 as a commercial anticancer agent if warranted by the clinical results. "There is extensive laboratory evidence from our group and others that Bcl-2 can make tumors very drug resistant. Over 90% of small cell lung cancers produce high levels of Bcl-2. We are very excited about bringing a laboratory observation into a clinical study for patients with small cell lung cancer, testing the idea that suppressing Bcl-2 may make a tumor that is notoriously difficult to treat much more sensitive to therapy," said the lead investigator, Dr. Charles Rudin of the University of Chicago Medical Center. In addition to this study in patients with small cell lung cancer, the collaboration between NCI and Genta will include other studies of G3139 in combination with standard chemotherapies for treatment of patients with colo- rectal cancer and relapsed acute leukemia. "This series of studies represents Genta's focused strategy of using G3139 to enhance the cancer-killing actions of selected, major chemotherapeutic drugs," said Dr. Raymond P. Warrell, Jr., President and CEO of Genta. "The taxane chemotherapies such as paclitaxel are among the most common treatments for lung and other common malignancies. This new study in patients with small cell lung cancer will provide valuable clinical data about safety and efficacy of paclitaxel combinations with G3139." "The rationale for study of Genta's G3139 in this disease is based on several clinical reports from the U.S., Japan, and Europe, all showing frequent over-expression of the Bcl-2 protein in small cell lung cancers," said Dr. Howard Fingert, Vice President for Clinical and Regulatory Affairs of Genta. "In addition, preclinical studies have shown enhanced anticancer effects when G3139 is combined with the taxane such as paclitaxel or docetaxel." Genta is also supporting clinical studies of G3139 in other types of cancer, including non-Hodgkins' lymphoma, prostate and breast cancers, and malignant melanoma. The FDA recently granted Fast Track designation for G3139 when used in combination with decarbazine for treatment of patients with advanced malignant melanoma. G3139 was designed to reduce the Bcl-2 protein level in cancer through an "antisense" mechanism that specifically targets the messenger-RNA produced by the Bcl-2 gene. In many human cancers, the Bcl-2 protein is believed to be a major factor in inhibiting spoptosis, or programmed cell death, and in contributing to resistance of those cancers to treatment with anticancer drugs. Genta Incorporated is a bio pharmaceutical company whose strategy consists of building a product and technology portfolio concentrating on cancer therapy including its Anticoda(TM) (antisense) products intended to treat cancer at its genetic source. For more detailed information about Genta, please visit our web site at www.Genta.com . The receive Genta Incorporated's latest news release and other corporate documents via fax, at no cost, dial 1-800-PRO-INFO; use the Company's symbol GNTA. Or visit the Financial Relations Board's web site at www.frbinc.com .