Healthcare Industry News: GPC Biotech
News Release - February 27, 2006
Spectrum Pharmaceuticals announces Presentation of New Satraplatin Clinical Data from Pharmacokinetics Study at ASCO Prostate Cancer SymposiumNew preclinical data on efficacy of satraplatin in prostate cancer cells and with Taxotere also presented
In December, a rolling submission of an NDA with the U.S. FDA was commenced, and the pivotal phase 3 trial was fully accrued
U.S. NDA filing by GPC Biotech is expected to be completed by the end of 2006
IRVINE, Calif., Feb. 27 (HSMN NewsFeed) -- Spectrum Pharmaceuticals Inc. (Nasdaq: SPPI ) today announced the presentation of new clinical and preclinical data on its lead drug candidate satraplatin at the ASCO Prostate Cancer Symposium: A Multidisciplinary Approach in San Francisco, California.
A poster entitled, "A Phase I Pharmacokinetic (PK)/Food Effect and Safety Study of Satraplatin," presented data from a study involving seventeen patients with advanced solid tumors. Most patients in the study were heavily pre-treated: the median number of prior chemotherapy treatments was three. Satraplatin appeared to be well tolerated, with no significant cardio, renal, liver or neurological toxicities observed. Other common toxicities like nausea, vomiting and diarrhea were mild to moderate and were reported to be controlled with prophylactic oral anti-emetic therapy. Seven patients in the study had hormone-refractory prostate cancer (HRPC), and all of the HRPC patients had received TaxotereŽ (docetaxel), with a median of three prior chemotherapy regimens. Satraplatin showed evidence of anti-tumor activity in this group: one patient had a partial response (RECIST criteria), and two patients had prolonged stable disease (durations of 3.5 and five months).
The study was designed to evaluate the effect of food on the bioavailability (i.e., the rate at which the drug is absorbed and the amount of drug absorbed) of satraplatin. Such data are useful in determining the best way for patients to take an oral drug. In this study, the peak plasma concentrations of satraplatin were decreased by approximately 20% following a high fat meal; however, the total amount of drug absorbed was not affected by food. The clinical implications of the reduced peak drug concentrations in the face of equivalent total amounts of drug absorbed in patients taking satraplatin following a high fat meal are not known.
A second poster entitled, "Efficacy of Satraplatin, an Oral Platinum Analogue in Prostate Cancer: Synergistic Activity with Docetaxel," reviewed the preclinical results of studies evaluating the cell-killing effect of satraplatin and its metabolite on prostate cancer cells. In vivo and in vitro data showed that satraplatin and its active metabolite, JM-118, inhibited the growth of prostate cancer cells in a dose-dependent fashion. In addition, when satraplatin or JM-118 was combined in vitro with Taxotere, a synergistic effect was demonstrated in prostate cancer cells. This synergistic effect was strongest when Taxotere was followed by JM-118.
Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. Spectrum believes that satraplatin is also the only platinum compound that has demonstrated activity in a randomized trial in HRPC.
In December 2005, patient enrollment in a Phase 3 registrational trial -- the SPARC trial -- which is assessing the safety and efficacy of satraplatin in combination with prednisone as a second-line chemotherapy in patients with HRPC was completed and the rolling submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) was initiated. Also in December 2005, GPC Biotech, the Company's co-development partner, signed a co- development and licensing agreement with Pharmion for satraplatin for Europe and certain other territories.
Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in HRPC, ovarian cancer and small cell lung cancer. Other trials evaluated the effects of adding satraplatin to radiation therapy, a clinical application in which satraplatin's oral bioavailability could be particularly advantageous. A Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. Several other Phase 1 and 2 studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned. In 2002, Spectrum licensed to GPC Biotech worldwide rights to satraplatin, and retained copromotion rights in USA under certain conditions. Additional information on satraplatin can be found in Spectrum website at www.spectrumpharm.com and the Anticancer Programs section of the GPC Biotech at www.gpc-biotech.com website.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. For more information, please visit our website at www.spectrumpharm.com.
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, the Company's operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company's strategic alliance partners, that satraplatin has shown promising safety and efficacy in the results discussed above, including a synergistic effect in prostate cancer cells when combined in vitro with Taxotere, that an oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications, that the NDA filing is expected to be completed in the second half of 2006, that satraplatin is also the only platinum compound that has demonstrated activity in a randomized trial in HRPC, that other trials evaluated the effects of adding satraplatin to radiation therapy, a clinical application in which satraplatin's oral bioavailability could be particularly advantageous, that several other Phase 1 and 2 studies evaluating satraplatin in combination with other therapies and in various cancers are underway or planned 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, 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 past results are not indicative of future results, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, 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.
Source: Spectrum Pharmaceuticals
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