If Pfizer is conducing large pilot efficiency trials in variety of tumor types for CP-385 as stand alone therapy (and in combination with chemo-agents), why the heck they didn't indicate any efficiency results from two PI trials? Or, Pfizer is designing trials based on IMCL and/or Zeneca (yes right) results for similar compounds?
I guess, it is time to shake-up OSIP IR department.
Company Press Release
SOURCE: OSI Pharmaceuticals, Inc.
OSI Pharmaceuticals, Inc. Reports the Presentation of Phase I Data for CP-358,774 at ASCO Meeting
UNIONDALE, N.Y., May 17 /PRNewswire/ -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP - news) announced today that data from two Phase I trials of CP-358,774, a novel, orally active inhibitor of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase, has been reported at the annual meeting of the American Society of Clinical Oncology (ASCO). The compound was discovered as part of OSI's long standing cancer alliance with Pfizer, Inc (NYSE: PFE - news). The Pfizer-sponsored studies were designed to assess the pharmacokinetics and safety of CP-358,774. Results showed that therapeutically relevant concentrations of CP-358,774 were achieved on well tolerated, chronic-dosing schedules of the drug. A large scale Phase II clinical program testing the efficacy of CP-358,774 against a variety of tumors, both as a single agent and in combination with existing chemotherapy regimens, has been initiated.
CP-358,774 is a potent, small molecule, anti-tumor agent that directly inhibits the EGFR tyrosine kinase, a receptor that is over-expressed in many solid tumors including breast, lung, ovarian and head and neck cancers. The compound inhibits EGFR activity in tumor cells with greater than a thousand-fold selectivity against other human tyrosine kinases. Long term oral dosing studies in xenograft animal models (human tumors grown in mice) identified an effective concentration of the drug in blood at which anti-tumor activity was observed. Experts predict that anti-EGFR therapeutics will need to be administered over extended periods in order to deliver optimal benefit to the cancer patient. Both Phase I studies, which were conducted by the Von Hoff group in San Antonio, PRN Research, Inc. in Dallas, and at Beth Israel in Boston, were designed to assess the ability of various dosing regimens of CP-358,774 to attain those target concentrations in Phase I cancer patients on well tolerated chronic dosing regimens. In both trials, CP-358,774 was shown to be very well tolerated at doses that met the pharmacokinetic goals of the study.
''These Phase I studies have provided a sound basis for the further clinical development of CP-358,774,'' stated Colin Goddard, Ph.D., President and Chief Executive Officer of OSI Pharmaceuticals, Inc. ''We are very pleased with the advancement into Phase II trials of this project and with the overall progress that has been made in our cancer collaboration with Pfizer.''
Three other product candidates arising from the OSI / Pfizer alliance, including CP-564,959, an anti-angiogenesis agent, are in late stage pre-clinical development. The program is focused on the discovery and development of novel, small molecule anti-tumor agents targeting oncogenes, tumor suppressor genes, angiogenisis and apoptosis. OSI will receive royalties from Pfizer on sales of approved products.
OSI Pharmaceuticals is a leading drug discovery company with a substantial pipeline of product opportunities for commercialization with the pharmaceutical industry. OSI's research programs are focused in the areas of cancer therapeutics and diagnostics, cosmeceuticals, and anti-infectives. OSI utilizes a comprehensive drug discovery and development capability to facilitate the rapid and cost-effective discovery and development of novel, small molecule compounds in more than 30 research and development programs. OSI is involved in long-term research alliances with Pfizer, Novartis, Hoechst Marion Roussel, Sankyo, and Bayer.
For additional information on OSI Pharmaceuticals, please visit OSI's Web site at: osip.com.
This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, uncertainties related to the identification of lead compounds, the successful pre-clinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third party reimbursement, and other factors described in OSI Pharmaceuticals' filings with the Securities and Exchange Commission.
SOURCE: OSI Pharmaceuticals, Inc.
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