• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Spectrum Pharmaceuticals to Present Phase 2 Data on Ortataxel in Breast Cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting

Posted on: Monday, 19 May 2008, 09:00 CDT

Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI) will present Phase 2 data on ortataxel at the 44th American Society of Clinical Oncology (ASCO) Annual Meeting being held May 30 to June 3, 2008 at the McCormick Place Convention Center in Chicago, Illinois. Ortataxel is a third-generation orally bioavailable taxane, that has activity in tumor models resistant to paclitaxel and docetaxel. A study indicating activity in taxane-resistant non-small cell lung cancer had been previously reported. Results of the Phase 2 study in resistant breast cancer patients will be presented in a poster session on Monday, June 2, 2008. The abstract, entitled "Phase 2 Study of Ortataxel in Taxane-Resistant Breast Cancer" is available now on the ASCO website, www.asco.org.

"Ortataxel has demonstrated activity in taxane-refractory tumors in Phase 2 trials, and we believe that with further clinical development, it could be an effective treatment option within the multi-billion dollar taxane market," said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "We plan to initiate a Phase 2 trial in relapsed lung cancer in the second half of 2008."

This single-arm Phase 2 study was performed in 23 centers, in patients with advanced or metastatic breast cancer with resistant disease (defined as disease progression within 6 months of the start of prior treatment with another taxane). Patients received ortataxel, 75 mg/m2 as a 1-hour i.v. infusion every 3 weeks. Primary endpoint was objective tumor response, complete (CR) or partial (PR).

Of the 85 patients accrued, 82 were treated and 76 were evaluable for response. Nearly half the patients had an impaired general condition (performance status of 1 or 2), 31% had received more than 4 distinct chemotherapy regimens and 62% had been previously irradiated.

There were 6 PRs (7% of all treated; 95% confidence interval 2.5-12%), with a median response duration of 7 months (range, 4-9 months). Only 2 of the 6 responders had a long-lasting prior response to a taxane. Additionally, 31 patients (38%) experienced disease stabilization (SD) lasting 1.5 - 11+ months. Thus the overall disease control rate (PR + SD) was 45%.

Adverse effects of any grade were seen in 80 patients, including 2 deaths from liver failure. Neutropenia was present in 74%. Peripheral neuropathy was severe in 5%. Fatigue and malaise were also significant. Hematologic side effects were graded as severe in 57% while non-hematologic severe effects were noted in 9% of patients.

Ortataxel retains encouraging activity and clinical benefit in breast cancer patients who are resistant to paclitaxel or docetaxel combinations. Its toxicity, comparable in type to these two other taxanes, was tolerable in this patient population, who had received heavy prior treatment.

About Ortataxel

Ortataxel (14-beta-hydroxydeacetylbaccatin) belongs to a new generation of taxanes with the potential to be active in tumors resistant to Bristol-Myers Squibb's Taxol(R) (paclitaxel) and Sanofi-Aventis' Taxotere(R) (docetaxel). The bioavailability of ortataxel following oral administration has been confirmed in previous studies. Phase 2 studies in taxane-refractory solid tumors have indicated a good level of activity. The safety profile of ortataxel so far has been comparable to that of paclitaxel and docetaxel.

The Company licensed worldwide rights to Ortataxel from Indena S.p.A., a privately owned Italian company that discovered ortataxel.

About Spectrum Pharmaceuticals

We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Our strategy consists of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products with a focus on oncology and urology; establishing a commercial organization for our approved drugs; continuing to build the finest possible team of people with demonstrated skills, passion, commitment and a track record of success in developing and commercializing drugs in our areas of focus; and leveraging the expertise of partners around the world to assist us in implementing this strategy. For more information, please visit our website at www.spectrumpharm.com.

Forward-looking statement - This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the safety and efficacy of ortataxel, that ortataxel could be an effective treatment option within the multi-billion dollar taxane market, that we will initiate a Phase 2 trial in relapsed lung cancer in the second half of 2008 and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, that early clinical data may not be indicative of future results, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.(TM), TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

(C) 2008 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

Source: Business Wire

More News in this Category