GNTA shorts on run
Genta Launches Pivotal Registration Study of its Lead Antisense Compound in Malignant Melanoma
LEXINGTON, Mass.--(BW HealthWire)--March 9, 2000--Genta Incorporated (Nasdaq: GNTA) announced today the launch of its first pivotal study for registration of its lead antisense compound, G3139. The study will be a randomized controlled trial of G3139 in combination with dacarbazine (DTIC) for patients with advanced malignant melanoma. The study will be conducted at multiple sites within North America and Europe. The Company has received "Fast Track" designation for this indication from the U.S. Food and Drug Administration. This designation is granted for diseases that have important clinical needs, and will enable the Company to begin preparation of its New Drug Application for U.S. marketing as a "rolling submission" over the next 18 months. The Company believes that positive results from this study, combined with other clinical safety and efficacy data, should be sufficient for FDA approval.
"With this study, Genta assumes a leadership position in antisense cancer therapy, the only such compound in a Phase 3 trial," commented Dr. Raymond P. Warrell, Jr., President and CEO. Dr. Warrell went on to note: "The melanoma trial is the first of several planned registration studies that are designed to markedly augment the effectiveness of existing state-of-the-art treatments. G3139 (which will be renamed shortly pending completion of a trademark search) is directed against Bcl-2, which is widely believed to play a more central role in the pathogenesis of most human cancers relative to any other antisense target currently in clinical investigation."
"G3139 represents a highly innovative approach to the therapy of malignant melanoma," observed Dr. Frank Haluska, MD, PhD, Director of the Melanoma Program at Massachusetts General Hospital, and Assistant Professor of Medicine at Harvard Medical School. "If successful, this trial may prove to be a major advance in the care and treatment of patients with this devastating disease."
In many human cancers, the bcl-2 protein is believed to be a major factor in inhibiting apoptosis (or programmed cell death), which is believed to contribute to both inherent and acquired resistance to anticancer treatments. G3139 was designed to reduce the bcl-2 protein level in cancer cells through an "antisense" mechanism that specifically targets the messenger-RNA produced by the bcl-2 gene.
Genta Incorporated (Nasdaq: GNTA) is a biopharmaceutical company that is building a product and technology portfolio concentrating on cancer therapy including its Anticode(tm) (antisense) products, as well as other important anticancer products. Genta aims to become a direct marketer of its drugs in the United States. For more detailed information about Genta, please visit our website at www.Genta.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. Further 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. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurances that the Company's expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement and other factors detailed in the Company's reports filed with the Securities and Exchange Commission.
CONTACT:
Genta Incorporated
Gerald Schimmoeller, 781-860-5142
Chief Financial Officer
Info@genta.com
KEYWORD: MASSACHUSETTS
BW1151 MAR 09,2000
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