To: bob zagorin who wrote (1249 ) 12/9/1999 3:40:00 PM From: bob zagorin Read Replies (1) | Respond to of 1870
NCI Commences Trial of Genta's bcl-2 Antisense Compound Combined With Chemotherapy for Relapsed Acute Leukemia -- Genta Expands Scope of G3139 Research -- Potent Effects of Genta Drug in Human Leukemia/Lymphoma Cells -- Reported at American Society of Hematology Meeting -- G3139 Recently Granted Fast Track Designation in Malignant Melanoma by FDA LEXINGTON, Mass., Dec. 9 /PRNewswire/ -- Genta Incorporated (Nasdaq: GNTA) announced that the National Cancer Institute (NCI) has commenced a study of its lead development compound G3139, in combination with fludarabine (Fludara(R), Berlex) and cytosine arabinoside for treatment of relapsed acute leukemia. The study is being conducted at Ohio State University under a Cooperative Research and Development Agreement (CRADA) between Genta and the NCI that had been previously announced. In a related development, scientists from Yale University School of Medicine reported potent anticancer effects of G3139 when targeting malignant human lymphoma or leukemia cells studied in laboratory models in vivo. These results were presented at the American Society of Hematology meeting in New Orleans on December 6. The results showed specific and potent action of G3139 to reduce bcl-2 protein levels, which correlated with profound reduction of tumor cell growth and increase of "apoptosis" or programmed cell death of the neoplastic cells. In mouse models grafted with the malignant cells, the animals uniformly died from progressive cancer within 46 days; however, all mice treated with G3139 remained alive for over 75 days without clinical signs of the disease. "These developments mark important new initiatives for Genta in patients with hematologic cancers," said Genta's President and CEO, Dr. Raymond P. Warrell, Jr. "The Company's strategy is to combine G3139 with selected important drugs in leukemia and lymphoma. We are greatly pleased to be pursuing the program in acute leukemia with NCI. Genta also continues to support studies in specific tumor types that will define the role of G3139 in cancer therapy, including studies for patients with lymphoma, prostate, breast, small cell lung, and malignant melanoma." "Genta is excited about the quality and commitment of both of these investigators and the major U.S. centers that are collaborating with us and NCI in our development plan for G3139," said Dr. Howard Fingert, Genta Vice President for Clinical and Regulatory Affairs. The FDA recently granted Fast Track designation for G3139 when used in combination with dacarbazine for treatment of patients with advanced malignant melanoma. The goal of the Genta - NCI collaboration is to provide new treatment options for patients with specific cancer indications and ultimately to obtain approval of G3139 as a commercial anticancer agent if warranted by the clinical results. 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 apoptosis, or programmed cell death, and in contributing to resistance to treatment with anticancer drugs. Genta Incorporated (Nasdaq: GNTA) is a biopharmaceutical company whose strategy consists of building a product and technology portfolio concentrating on cancer therapy including its Anticode(TM) (antisense) products intended to treat cancer at its genetic source. For more detailed information about Genta, please visit our website at www.Genta.com . To 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 . The statements contained in this press release that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the expectations, beliefs, intentions or strategies regarding the future. Without limiting the foregoing, the words "anticipates," "believes," "expects," "intends," "may" and "plans" and similar expressions are intended to identify forward-looking statements. The Company intends that all forward-looking statements be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the Company's views as of the date they are made with respect to future events, but are subject to many risks and uncertainties, which could cause the actual results of the Company to differ materially from any future results expressed or implied by such forward-looking statements. For example, the results obtained in pre-clinical or clinical studies reported above may not be indicative of results that will be obtained in future clinical trials; Genta has not successfully completed human clinical trials of a product based on antisense technology; and delays in the completion of clinical trials as a result of delays in patient enrollment or other factors may occur. Examples of such risks and uncertainties also include, but are not limited to: the obtaining of sufficient financing to maintain the Company's planned operations; the timely development, receipt of necessary regulatory approvals and acceptance of new products; the successful application of the Company's technology to produce new products; the obtaining of proprietary protection for any such technology and products; the impact of competitive products and pricing and reimbursement policies; and the changing of market conditions. The Company does not undertake to update forward-looking statements. SOURCE Genta Incorporated CO: Genta Incorporated; National Cancer Institute ST: Massachusetts IN: MTC SU: 12/09/1999 14:40 EST prnewswire.com