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December 12, 2005
Cougar Biotechnology Announces Positive Interim Results from Phase I trial for CB3304 (Noscapine) in non-Hodgkin's Lymphoma
Los Angeles, CA, December 12, 2005 - Cougar Biotechnology, Inc, a privately held biotechnology company, today announced positive interim data from an ongoing Phase I trial of the Company’s drug CB3304 (noscapine), an orally active alkaloid that has been shown to induce conformational changes in tubulin, in patients with relapsed or refractory non-Hodgkin’s lymphoma. The data was presented as a poster presentation at the American Society of Hematology Annual Meeting in Atlanta, Georgia.
The trial is an open label dose escalating study where cohorts of subjects with relapsed/refractory non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL/SLL) were treated at one of three different dose levels involving total daily doses of 1 g, 2 g, and 3 g per day. At each dose level, noscapine was administered orally on a three times a day schedule for 49 days. In the trial, responses for NHL patients were evaluated using the International Working Group Response Criteria for NHL and responses for CLL patients were evaluated using the NCI Working Group criteria. For both NHL and CLL patients, toxicity was graded according to the NCI common toxicity criteria (CTC)
At this interim analysis, 12 patients with a median age of 65 years (range 38-71) have been accrued. Four subjects had CLL/SLL, 2 had mantle cell lymphoma, one had follicular grade III, 4 had diffuse large cell lymphoma (DLC), and one had lymphoplasmacytic low grade lymphoma. These interim results suggest:
- Of the 10 patients that are evaluable for response, one patient with follicular grade III disease has had a partial response. This patient initially demonstrated stabilization of their disease for a period of approximately four years before achieving a partial response. In addition, two patients, one with mantle cell lymphoma and one with DLC have demonstrated stable disease of duration 30 days and 77 days, respectively.
- Noscapine has been well tolerated, with no grade 3 or 4 hematological toxicities. One grade 3 neurotoxicity consisting of depressed level of consciousness was experienced at the 3 g dose level.
- A larger study of noscapine is warranted to evaluate the efficacy of the compound in patients with lymphoma.
Anil Tulpule, MD, Associate Professor of Clinical Medicine (Hematology) at the University of Southern California, Keck School of Medicine and principal investigator of the trial stated "We are encouraged by the suggestion of efficacy and relative lack of toxicity that noscapine has demonstrated in this trial. This data supports continued clinical development of noscapine in NHL."
Dr. Arie Belldegrun, MD, FACS, Vice Chairman of the Board of Directors of Cougar Biotechnology said, "We are pleased to see the initial indication of efficacy of CB3304 in NHL without any major toxicities. We look forward to continued clinical development of the drug in NHL and in other malignancies." Alan H. Auerbach, Chief Executive Officer and President of Cougar Biotechnology added "This is the first presentation of clinical data with CB3304 since Cougar completed the licensing agreement for the drug last year. The drug’s preliminary anticancer activity, good tolerability and unique mechanism of action provide strong support for noscapine’s continued clinical development."
About Cougar Biotechnology
Cougar Biotechnology, Inc. is a Los Angeles-based private biotechnology company established to in-license and develop clinical stage drugs, with a specific focus on the field of oncology. Cougar's oncology portfolio includes CB7630, which has completed Phase I clinical trials in prostate cancer, CB3304, which is currently being tested in a Phase I trial in non-Hodgkin's lymphoma and CB1089, which has been clinically tested in a number of solid tumor types.
Further information about Cougar Biotechnology can be found at www.cougarbiotechnology.com.
Contact
Alan H. Auerbach
Cougar Biotechnology, Inc.
+1 310 443 4209
ahauerbach@cougarbiotechnology.com
This press release contains forward-looking statements that involve risks and uncertainties that could cause Cougar's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Cougar's development efforts relating to its product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Cougar's product candidates, the risk that the results of clinical trials may not support Cougar's claims, Cougar's reliance on third-party researchers to develop its product candidates and its lack of experience in developing pharmaceutical products. Cougar assumes no obligation to update these forward-looking statements, except as required by law.
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
