Genta Announces Clinical Presentations on Lead Compounds, Tesetaxel and Genasense®, at 2010 Annual ASCO Meeting

BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)-- Genta Incorporated (OTCBB: GETA) announced today that data from clinical trials of the Company's late-stage compounds, tesetaxel and Genasense® (oblimersen sodium) Injection, will be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting will be held from June 4-9, 2010 in Chicago, IL.

Highlights of the presentations include further details on the Phase 3 trials of Genasense in advanced melanoma, including a pooled analysis of early results from the AGENDA trial combined with data from Genta’s previous Phase 3 study, both of which evaluated dacarbazine chemotherapy with or without Genasense. In addition, updated results from a trial in advanced melanoma that combined Genasense plus temozolomide and Abraxane® will be presented, including data from the cohort of patients that received Genasense as a 1-hour, twice-weekly, intravenous (IV) infusion (unlike prior trials that employed a continuous IV infusion for 5-consecutive days every 3 weeks).

Updated clinical and pharmacokinetic (PK) data on tesetaxel, the leading oral taxane in clinical development, will be presented from a dose-ranging study using a once every 3-weeks schedule. The presentation will also include initial clinical and PK data from a dose-ranging study that employs a new schedule whereby the drug is administered weekly for 3 consecutive weeks, followed by 1 week off.

Titles, dates, and times of these presentations appear below.

Results of pooled analyses from two phase III trials of 1,085 patients (pts) with advanced melanoma: Oblimersen (OBL) plus dacarbazine (DTIC) versus DTIC alone. (Abstract #8573). Sunday June 6, 2010. Poster Session: Melanoma/Skin Cancers: 8 AM – 12 PM.

Relation between baseline LDH and tumor burden in advanced melanoma in two phase III trials of oblimersen-dacarbazine (OBL-DTIC) vs. DTIC. (Abstract #8557). Sunday June 6, 2010. Poster Session: Melanoma/Skin Cancers: 8 AM – 12 PM.

Oblimersen 1-hour IV infusion in combination with temozolomide and albumin-bound paclitaxel in patients with advanced melanoma. (Abstract #8561). Sunday June 6, 2010. Poster Session: Melanoma/Skin Cancers: 8 AM – 12 PM.

An inter-subject dose-escalation study of tesetaxel administered orally once every 3 weeks and once weekly for 3 consecutive weeks in patients with advanced or metastatic solid tumors. (Abstract #TPS159). Monday June 7, 2010. Poster Session: Clinical Trials, Special Session: 8 AM – 12 PM.

Phase I dose-ranging, pharmacokinetic (PK) study of tesetaxel, a novel orally active tubulin-binding agent. (Publication only).

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. Two major programs anchor the Company’s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense® is being developed as an agent that may enhance the effectiveness of anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from the recently completed randomized Phase 3 study of Genasense® in patients with advanced melanoma (the AGENDA trial). The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta has initiated a broad clinical program to evaluate the safety and efficacy of tesetaxel in patients with solid tumors. In the U.S., Genta is exclusively marketing Ganite® (gallium nitrate injection), which is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite® that are being evaluated as potential treatments for diseases associated with accelerated bone loss. Ganite® and Genasense® 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.

Safe Harbor

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. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words “potentially”, “anticipate”, “could”, “calls for”, and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:

  • the Company’s ability to obtain necessary regulatory approval for its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency;
  • the safety and efficacy of the Company’s products or product candidates;
  • the commencement and completion of any clinical trials;
  • the Company’s assessment of its clinical trials;
  • the Company’s ability to develop, manufacture, license, or sell its products or product candidates;
  • the Company’s ability to enter into and successfully execute any license and collaborative agreements;
  • the adequacy of the Company’s capital resources and cash flow projections, or 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
  • 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.

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 2009 and its most recent quarterly report on Form 10-Q.



CONTACT:

Genta Investor Relations
908-286-3980
[email protected]

KEYWORDS:   United States  North America  Illinois  New Jersey

INDUSTRY KEYWORDS:   Health  Biotechnology  Oncology  Pharmaceutical

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