Genta Announces Results of Phase 1 Study Using Genasense Administered by Intermittent Subcutaneous InjectionStudy Shows Safety and Pharmacokinetics Similar to IV Doses in Phase 3 CLL Trial
BERKELEY HEIGHTS, N.J., June 06, 2007 /PRNewswire-FirstCall/ -- Genta Incorporated announced the publication of preliminary clinical results that show the Company's lead anti-cancer drug, Genasense(R) (oblimersen sodium) injection, can be safely administered by intermittent subcutaneous (SC) injection, as well as by brief intravenous (IV) infusion. These regimens may eventually reduce or eliminate the current requirements for administering Genasense by continuous IV (CIV) infusion. The new schedules also expand the potential for use in combination with anticancer drugs that are administered on a daily or weekly basis. The data were published in proceedings of the annual meeting of the American Society of Clinical Oncology (ASCO) that was held this week in Chicago, IL.
The SC study used a new formulation of Genasense that was concentrated 5- fold greater than that used in previous Phase 3 trials. In a dose-ranging pharmacokinetic (PK) and pharmacodynamic trial, bolus SC injections of 75, 150 and 225 mg yielded dose-proportional plasma concentrations that were associated with down-regulation of Bcl-2 in blood cells. The 225 mg dose level achieved exposure PK parameters that were similar to levels achieved at the 3 mg/kg CIV daily dose level that was tested in the recent Phase 3 trial of Genasense in chronic lymphocytic leukemia (CLL).
A second phase of the program is testing escalating doses of Genasense administered as a 2-hour IV infusion. Single 150 mg doses, as well as repeated 150 mg doses administered daily for 5 consecutive days, have been well-tolerated. To date, the principal adverse events have been reversible skin reactions at the injection site on the SC schedule and transient fever on the brief IV schedule.
"These highly encouraging data represent important next steps that may greatly improve dosing convenience for patients," commented Dr. Raymond P. Warrell, Jr., Chairman and CEO of Genta. "We are continuing dose escalation in the brief IV schedule and hope to incorporate these regimens into future studies using new agents that are administered on daily or weekly schedules."
Preclinical studies have demonstrated that high-dose intermittent treatment with Genasense was associated with increased uptake of the drug within tumors and yielded superior efficacy when combined with paclitaxel, temozolomide, (Temodar(R); Schering Plough, Inc.) and multiple kinase inhibitors (erlotinib, imatinib, sunitinib, and sorafenib) in a highly aggressive model of malignant melanoma. A summary of these preclinical data can be viewed at: http://www.genta.com/Genta/InvestorRelation/2006/press_20061109.html
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 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. Genta is partnered with IDIS (www.idispharma.com) on a program whereby both Ganite(R) and Genasense(R) are available on a "named- patient" basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
This press release may contain 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 any proposed settlement of such litigation; -- the Company's ability to regain compliance with the NASDAQ's listing qualifications, or its ability to successfully appeal the NASDAQ delisting; 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 2006 and its most recent quarterly report on Form 10-Q.
CONTACT: For Genta Incorporated Tara Spiess/Andrea Romstad TS Communications Group, LLC (908) email@example.com
CONTACT: Tara Spiess or Andrea Romstad, both of TS Communications Group,LLC, +1-908-286-3980, , for Genta Incorporated firstname.lastname@example.org
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Posted: June 2007