Key Developments For Onyx Pharmaceuticals Inc
Onyx Pharmaceuticals Inc (ONXX.O) (Consolidated Issue listed on NASDAQ Global Market)
Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals Initiate Phase 3 Trial Of Nexavar In Patients With Non-Responsive Thyroid Cancer
Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals announced that the companies have begun enrolling patients in an international Phase 3 trial to evaluate Nexavar (sorafenib) tablets for the treatment of patients with radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer. This Phase 3 trial was started based on the results from Phase 2 clinical trials evaluating Nexavar in patients with advanced thyroid cancer. The DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial is an international, multicenter, randomized, placebo-controlled study that will enroll approximately 400 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer (papillary, follicular and Hurthle cell) who have received no prior systemic therapy. Patients will be randomized to receive 400 mg of oral Nexavar twice daily or matching placebo. Patients will continue on treatment until disease progression, toxicity, non-compliance or withdrawal of consent. At the time of progression, patients receiving placebo will have an option to cross over to Nexavar at the discretion of the investigator, based on the patient's clinical status. The primary endpoint of the study is progression-free survival as defined by Response Evaluation Criteria in Solid Tumors (RECIST). The safety and tolerability of the two treatment groups will also be compared.
Onyx Pharmaceuticals To Acquire Proteolix, Inc.
Onyx Pharmaceuticals announced that it has signed a definitive agreement to acquire Proteolix, Inc., a privately held biopharmaceutical company focused on discovering and developing novel therapies that target the proteasome for the treatment of hematological malignancies and solid tumors. Under the terms of the transaction, Onyx will make a $276 million cash payment upon closing of the transaction. Additional payments include $40 million payable in 2010 based on the achievement of a development and up to $535 million contingent upon the achievement of certain regulatory approvals for carfilzomib in the U.S. and Europe. Of the potential $535 million, a payment of $170 million is based upon the achievement of accelerated U.S. Food and Drug Administration approval. The transaction is expected to close in the fourth quarter of 2009.
Onyx Pharmaceuticals And Bayer AG's Bayer HealthCare Pharmaceuticals Announce Results From Randomized, Placebo-Controlled Phase 2 Trial Sponsored By Northwestern University
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced results from a randomized, placebo-controlled Phase 2 trial sponsored by Northwestern University. The study, which evaluated Nexavar (sorafenib) tablets in combination with the chemotherapeutic agent, paclitaxel, in patients with locally advanced or metastatic HER-2 negative breast cancer, demonstrated a positive trend towards improvement of progression-free survival in the treatment group (p-value=0.09). The safety and tolerability profile of the combination was consistent with the previous experience with each agent and no new toxicities were observed. The preliminary results in this study demonstrate a clinical signal in favor of this treatment combination. Bayer and Onyx Pharmaceuticals recently reported statistically significant results in a randomized Phase 2 trial demonstrating that Nexavar in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression free survival by 74% in patients with locally advanced or metastatic HER-2 negative breast cancer. Treatment with Nexavar plus capecitabine was tolerable and resulted in no new side effects. Common grade 3 or 4 treatment-related adverse events included hand-foot skin reaction, diarrhea, dyspnea, neutropenia and mucositis. Bayer HealthCare Pharmaceuticals Inc. Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG
Onyx Pharmaceuticals Initiates Phase 1 Study Of ONX 0801 In Advanced Solid Tumors
Onyx Pharmaceuticals announced that it has begun enrolling patients in a Phase 1 study of ONX 0801, a alpha-folate receptor-mediated thymidylate synthase (TS) inhibitor, as a potential treatment for advanced solid tumors. This open-label, dose-finding study will evaluate the safety and pharmacokinetics of ONX 0801 in patients with advanced solid tumors. The open-label, dose-finding Phase 1 study is evaluating the safety and pharmacokinetics of ONX 0801 in approximately 60 cancer patients with advanced solid tumors. Cohorts of 3 to 6 patients will receive ONX 0801 at escalating doses until a maximum tolerated dose is determined. Each patient will receive a 3-hour intravenous infusion of ONX 0801 weekly (i.e., on days 1, 8, and 15) of repeated 21-day treatment cycles.
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. Announces Full Results From Collaborative Group-Sponsored Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial Involving Nexavar
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. announced the full results from their first collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trial showing that Nexavar (sorafenib) tablets in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression-free survival in patients with advanced breast cancer. The principal investigator of this study, reported that patients receiving Nexavar plus capecitabine had a 74% improvement in the time they lived without their disease progressing compared to those who received the chemotherapy alone. The difference in median progression-free survival of Nexavar plus capecitabine versus capecitabine plus placebo was statistically significant, 6.4 months vs. 4.1 months (HR=.576, p=0.0006). The study evaluated Nexavar in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. Overall, treatment with Nexavar plus capecitabine was tolerable and resulted in no new side effects. The randomized, double-blind, placebo-controlled Phase 2 study evaluated Nexavar in combination with the oral chemotherapeutic agent, capecitabine, in 229 patients. These patients had locally advanced or metastatic HER-2 negative breast cancer and had received no more than one prior chemotherapy in this setting. The primary endpoint of the study was progression-free survival.
