ATLANTA, Ga., Dec. 12 /PRNewswire-FirstCall/ -- Genta Incorporated announced the presentation of preliminary clinical results regarding the use of its lead anticancer compound, Genasense(R) (oblimersen sodium) Injection, in combination with fludarabine plus rituximab (Rituxan(R); Genentech/IDEC) in patients with chronic lymphocytic leukemia (CLL). The data were presented this weekend at the 47th Annual American Society of Hematology meeting in Atlanta, GA.
Two clinical studies have explored the use of Genasense plus rituximab, with and without cytotoxic chemotherapy, in patients with non-Hodgkin’s lymphoma. The goal of this ongoing Phase 1-2 study was to evaluate safety and preliminary activity across a range of fludarabine and Genasense doses when used in combination with a “stepped dosing” schedule of rituximab. The first 24 patients were treated in cycle 1 with 1.5 mg/kg/day of Genasense (50% of the usual CLL dose) for 7 days, plus 3 days of fludarabine (25 mg/m(2)/day), and two rituximab doses (125 and 250 mg/m(2)/d on days 4 and 6, respectively). In cycles 2 through 6, the Genasense dose was escalated to 3 mg/kg/day and the rituximab dose (375 mg/m(2)) was given once on day 5. Of these patients, 19 had relapsed from previous treatment and five were previously untreated.
All five previously untreated patients achieved a major response, including one “molecular” complete response (mCR) (i.e., confirmed by two-color flow cytometry), one nodular partial response (nPR), and three partial responses (PR). Sixty-eight percent (68%) of the previously treated patients had received therapy with rituximab, and 74% had previously received fludarabine. Nonetheless, 10 of the 19 previously treated patients achieved major responses, including one mCR, one nPR, and 10 PR. Seven patients developed Grade 3 rituximab-associated infusion reactions, two of which were considered serious. However, most of these reactions occurred during the first cycle of treatment, and most patients were able to continue rituximab treatment. No other serious reactions occurred in more than 1 patient each. Having demonstrated adequate safety in the initial cohort, accrual is continuing to a second cohort wherein full doses of all three drugs including fludarabine at 25 mg/m(2)/day for five days.
A randomized Phase 3 trial of 241 patients who received fludarabine plus cyclophosphamide (Flu/Cy) with or without Genasense showed that the addition of Genasense was associated with a significant increase in the proportion of patients who achieved a CR or nPR. All CR/nPRs in the Genasense group were “durable” (i.e., > six months in duration) and lasted significantly longer than the CR/nPRs that occurred in patients treated with Flu/Cy alone. This level of response was associated with significant clinical benefit, including relief of prospectively defined symptoms of CLL. Genta expects to complete its submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Genasense in combination with fludarabine and cyclophosphamide in patients with relapsed or refractory CLL later this month.
About Genasense
Genasense is the first oncology drug to directly target the biochemical pathway known as apoptosis whereby cancer cells are ultimately killed by chemotherapy. A protein known as Bcl-2 is highly expressed in many forms of human cancer and is believed to be a fundamental cause of resistance to anticancer therapy. By inhibiting production of Bcl-2, Genasense may enhance the activity of many forms of anticancer treatment.
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, the Company’s lead compound from its oligonucleotide program, is currently undergoing late-stage, Phase 3 clinical testing. 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 patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: http://www.genta.com.
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. 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/Form 10-K for 2004.
Genta Incorporated
CONTACT: Investors: Tara Spiess of TS Communications Group, LLC,+1-908-286-3980, info@genta.com; or Media: Greg Tiberend of Richard LewisCommunications, Inc., +1-212-827-0020, both for Genta Incorporated
Web site: http://www.genta.com/
