BERKELEY HEIGHTS, N.J., Oct. 13 /PRNewswire-FirstCall/ -- Genta Incorporated announced initiation of a Phase 1 clinical trial using a new anticancer drug derived from the Company’s DNA/RNA Medicines program. The new compound, known as G4460, uses antisense technology to target an oncogene known as c-myb that regulates key functions in cancer cells. Using an accelerated dosing schedule, this study will evaluate dosing regimens, safety, biologic activity, and down-regulation of c-myb in patients with advanced hematologic cancers. The clinical trial will be conducted using the General Clinical Research Center at the University of Pennsylvania, Philadelphia, PA. G4460 has been granted Orphan Drug Designation by the Food and Drug Administration for treatment of patients with chronic myelocytic leukemia (CML).
“The c-myb proto-oncogene regulates a number of proteins that are critical for growth of cancer cells,” commented Dr. Alan Gewirtz, Professor of Medicine and Pathology at the University of Pennsylvania School of Medicine and Leader of the Hematologic Malignancies Program in the Cancer Center. “Preclinical studies have shown that disruption of c-myb has antitumor effects, and this new trial seeks to evaluate whether these effects can be translated into an effective therapeutic strategy for patients.”
About G4460
G4460 is part of Genta’s DNA/RNA Medicines program. This program uses drugs that are based on chemical modifications of DNA or RNA to selectively knock out the function of genes that may be involved in the cause or progression of cancer. G4460 targets an oncogene product known as c-myb, which is a protein that directly binds to cellular DNA. C-myb is believed to regulate the expression of other genes that are involved in the growth and differentiation of cancer cells. Over-expression of c-myb blocks differentiation, promotes proliferation, and decreases apoptosis. Potential clinical targets for G4460 include CML, melanoma, neuroblastoma, and cancers of the breast, pancreas and colon. Genta has licensed key patents and technology related to the composition and human use of G4460.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company’s research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense(R) (oblimersen sodium) Injection is the Company’s lead compound from its oligonucleotide program. The Company has submitted a New Drug Application (NDA) to the Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has also completed a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. The leading drug in Genta’s small molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: http://www.genta.com.
Safe Harbor
This press release contains forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward-looking statements include, without limitation, statements about:
* the Company’s ability to obtain necessary regulatory approval for Genasense(R) from the U.S. Food and Drug Administration (“FDA”) or European Medicines Agency (“EMEA”); * the safety and efficacy of the Company’s products or product candidates; * the Company’s assessment of its clinical trials; * the commencement and completion of clinical trials; * the Company’s ability to develop, manufacture, license and sell its products or product candidates; * the Company’s ability to enter into and successfully execute license and collaborative agreements, if any; * the adequacy of the Company’s capital resources and cash flow projections, and the Company’s ability to obtain sufficient financing to maintain the Company’s planned operations; * the adequacy of the Company’s patents and proprietary rights; * the impact of litigation that has been brought against the Company and its officers and directors; and * the other risks described under Certain Risks and Uncertainties Related to the Company’s Business, as contained in the Company’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
The Company does not undertake to update any forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the Company’s Annual Report on Form 10-K for 2005 and its most recent quarterly report on Form 10-Q.
Genta Incorporated
CONTACT: Investor Relations, Tara Spiess or Andrea Romstad, both of TSCommunications Group, LLC, +1-908-286-3980, info@genta.com; or MediaRelations, Greg Tiberend of Richard Lewis Communications, Inc.,+1-212-827-0020, all for Genta Incorporated
Web site: http://www.genta.com/
