NCI Commences Trial of Genta's bcl-2 Antisense Compound Combined With Irinotecan for Relapsed Colo-rectal Cancer
LEXINGTON, Mass., Dec. 6 /PRNewswire/ -- Genta Incorporated (Nasdaq: GNTA) announced that the National Cancer Institute (NCI) has commenced a Phase 1-2 study of Genta's lead development compound, G3139. The study is in combination with irinotecan (Camptosar(R), Pharmacia & Upjohn) for the treatment of relapsed colo-rectal cancer. The study is being conducted under a Cooperative Research and Development Agreement (CRADA) between Genta and the NCI that was previously announced. 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.
Raymond P. Warrell, Jr., President and CEO of Genta, noted, "This is the first of a series of studies pursuant to the CRADA with NCI that represents the company's refocused strategy of using G3139 to enhance the cancer-killing actions of selected, major chemotherapeutic drugs."
The lead investigator for the colo-rectal study is Dr. Anthony Tolcher of the Institute for Drug Development (IDD) in San Antonio, Texas, a co-author of laboratory studies with G3139 published in the October, 1999 issue of Clinical Cancer Research. This study is also being conducted at Case Western University in Cleveland, Ohio.
"Colo-rectal cancer is one of the most common malignancies in the U.S. and worldwide, and while some new chemotherapies have been developed in the past years, the disease still relapses in most patients," Tolcher said. "Investigators at the Institute for Drug Development have conducted numerous clinical studies of cancer drug therapies, leading to rapid completion of clinical trials. These studies have broadly impacted the successful development of several anticancer drugs which are commonly used today. Building from the expanding clinical experience with G3139, and from the growing scientific evidence that links bcl-2 protein to tumor cell survival and resistance to cancer therapies, we are eager to evaluate G3139 in patients with relapsed colo-rectal cancer. New treatment options are certainly needed for the many patients who do not obtain durable benefit from available therapies."
"Genta is excited about the quality and commitment of IDD, Case Western and the major U.S. centers that are collaborating with us and the NCI in our development plan for G3139," said Dr. Howard Fingert, Genta Vice President for Clinical and Regulatory Affairs. Genta also continues to support studies in specific tumor types that will define the role of G3139 in cancer therapy. The FDA recently granted Fast Track designation for G3139 when used in combination with dacarbazine 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 apoptosis, or programmed cell death, and in contributing to resistance of those cancers to treatment with anticancer drugs. The rationale for using Genta's G3139 in this disease is based on several reports showing frequent expression of the bcl-2 protein in colo-rectal cancers, and preclinical studies showing enhanced anticancer effects when G3139 is combined with various types of chemotherapeutic agents.
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.
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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
ST: Massachusetts
IN: MTC
SU:
12/06/1999 11:56 EST prnewswire.com |
