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The presentations, given by Dr. Lyle J. Arnold Jr., Genta's vice president of research and development, and other Genta scientists, featured results of recent preclinical (animal) studies which included anti-tumor activity of G3139 as monotherapy against breast, colon and ovarian cancers and corroboration of a previous preclinical study which showed elimination of human melanoma tumors in mice treated with G3139 in combination with the chemotherapeutic agent dacarbazine (DTIC).
Additionally, Arnold reported on interim results of the company's Phase I/IIa clinical trial in non-Hodgkin's lymphoma.
The target of G3139 -- the BCL2 gene -- is a proto-oncogene involved in the inhibition of apoptosis (programmed cell death) of cancerous cells and is believed to be important in a number of solid tumor and hematological malignancies including non-Hodgkin's lymphoma, malignant melanoma, breast, colorectal, ovarian and prostate cancers.
The protein produced by the BCL2 gene has two known critical functions in the progression of cancer -- it makes cancer cells immortal, creating a survival advantage of malignant over normal cells and it confers resistance to radiation and chemotherapy, rendering these treatments ineffective in late-stage cancers.
High levels of the BCL2 protein are associated with a poor clinical prognosis for certain cancer patents. G3139 is designed to inactivate the RNA that produces the BCL2 protein product, thereby preventing cellular production of the protein.
G3139 is currently being evaluated in a Phase I/IIa human clinical trial against non-Hodgkin's lymphoma at the Royal Marsden Hospital in London. The dose-escalating, open label study is enrolling patients with advanced disease who have failed prior conventional treatments.
Nine patients have been treated to date. Four out of eight evaluable patients have demonstrated clinical and/or biological activity with one patient demonstrating a complete radiological response (defined by the World Health Organization as disappearance of all known disease).
This response has been confirmed by radiologists in London and San Diego. Clinical samples taken from patients showed drug plasma levels comparable to those previously found to be effective in mice. Tolerance to G3139 has been excellent so far and the trial is expected to continue until the maximum tolerated dose is reached.
"We continue to be excited by results in both preclinical and clinical studies of G3139," said Arnold. "The replication of the promising results we reported earlier in breast cancer and melanoma as well as the favorable preliminary clinical results in lymphoma underscore the importance of BCL2 as a gene target and of G3139 as a potential anti-cancer therapy."
Genta scientists also reported on a number of the company's in vitro and other preclinical findings reflecting work on improved drug delivery systems, including liposomal technologies, as well as second generation anti-BCL2 molecules.
Genta has had positive results with its cationic delivery program, showing successful delivery of its proprietary backbone chemistries into a wide variety of cell types. Antisense oligonucleotides made with these backbone chemistries have displayed biological activity including inhibition of RNA splicing and destruction of mRNA inside living cells.
Results of pharmacokinetic studies defined different drug plasma profiles following a variety of routes of administration. Liposomal delivery resulted in a 10 to 20-fold increase in solid tumor uptake of antisense oligonucleotides.
Certain matters discussed in this news release represent forward-looking statements that involve risks and uncertainties, including whether the proposed collaboration can be successfully carried out, whether preclinical studies will be successfully completed, whether clinical trials will be initiated, whether such trials will be successful, whether the company will have adequate funding to contribute to such trials, whether regulatory approvals can be obtained, the impact of competitive products, and other risks detailed from time-to-time in Genta's Securities and Exchange Commission (SEC) reports, including report on Form 10-K for the year ended Dec. 31, 1995, and Genta's quarterly reports on Form 10-Q.
These forward-looking statements represent Genta's judgment as of the date of this release. Actual results may differ materially from those projected. Genta disclaims, however, any intent or obligation to update these forward-looking statements.
Genta Inc. is an integrated biopharmaceutical company with a diversified product development pipeline. In the near term, the company is seeking funding to develop through a joint venture with Jagotec AG, oral controlled-release drugs utilizing the patented GEOMATRIX drug delivery technology.
Longer term, Genta is seeking funding to develop proprietary Anticode products to treat cancer at its genetic source.
CONTACT: Genta Inc., San Diego Thomas H. Adams, 619/455-2700
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