Key Developments For Exelixis, Inc.
Exelixis, Inc. (EXEL.O) (Nasdaq)
Exelixis, Inc. Announces Encouraging Phase 1 Data for PI3K Inhibitor Xl147 (SAR245408), in Combination with Erlotinib, Developed With Sanofi-aventis
Exelixis, Inc. announced interim data from an ongoing phase 1 dose-escalation trial of XL147 (SAR245408) in combination with the EGFR inhibitor erlotinib in patients with advanced solid tumors. XL147 is a selective, orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K). Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival, and resistance to chemotherapy and radiotherapy. The pathway also has been implicated as a mediator of resistance to epidermal growth factor receptor (EGFR) inhibitors. XL147 is being developed with sanofi-aventis. Preliminary pharmacokinetic (PK) analyses indicate that the PK profiles of XL147 and erlotinib administered in combination are similar to the PK profiles of each compound administered as a single agent. Pharmacodynamic assessments of blood, skin, and tumor samples demonstrate robust and simultaneous inhibition of signaling through the PI3K pathway and through EGFR, the target of erlotinib, after administration of the combination. Tumor biopsy samples from a patient with an ethmoid tumor showed marker reductions ranging from 39% to 44%. Sixteen patients were evaluable for safety assessments. Six patients have experienced serious adverse events (SAE), including one patient treated at the 600 mg XL147/150 mg erlotinib dose who experienced a drug rash and eosinophilia and systemic symptoms (Grade 4).
Exelixis, Inc. Announces Encouraging Phase 1 Data For PI3K Inhibitor XL147 (SAR245408) In Combination With Paclitaxel And Carboplatin
Exelixis, Inc. announced interim data from an ongoing phase 1 dose-escalation trial of XL147 (SAR245408) in combination with paclitaxel and carboplatin in patients with advanced solid tumors. XL147 is a selective, orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K). Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival, and resistance to chemotherapy and radiotherapy. Upregulation of PI3K signaling is associated with resistance to paclitaxel and carboplatin. Preclinical data suggest that XL147 potentiates the antitumor efficacy of paclitaxel and carboplatin without exacerbating the toxicity of this commonly used regimen. The study is evaluating escalating doses of XL147 administered daily for a 21-day cycle in combination with paclitaxel and carboplatin administered intravenously on Day 1 of the cycle. In Part A of the study, paclitaxel and carboplatin will be dose-escalated up to 175 mg/m2 and AUC 6, respectively, with expansion at the maximum tolerated dose (MTD) in patients with endometrial and ovarian cancer. In Part B, paclitaxel and carboplatin will be dose-escalated up to 225 mg/m2 and AUC 6, respectively, with expansion at the MTD in patients with non-small cell lung cancer (NSCLC).
Exelixis, Inc. Reiterates FY 2009 Revenue Outlook
Exelixis, Inc. reiterated its fiscal 2009 outlook and expects revenue in the range of $140-$170 million. According to Reuters Estimates, analysts were expecting the Company to report revenues of $152 million for the same period.
Exelixis, Inc. And Bristol-Myers Squibb Co. Report New Phase 2 Data For XL184 in Patients With Common And Aggressive Form Of Brain Cancer
Exelixis, Inc. and Bristol-Myers Squibb Co. announced the updated phase 2 clinical data which show that XL184 demonstrated activity in patients with glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The data from study XL184-201 were presented today during a poster session at the 2009 Joint Meeting of the Society for Neuro-Oncology and the AANS/CNS Section on Tumors. The study evaluates the safety, tolerability, and clinical activity of XL184 at continuous daily doses of 175 mg or 125 mg in patients with previously treated GBM, including some patients who had received prior antiangiogenic therapy. A total of 46 patients in first or second relapse were enrolled and dosed with 175 mg of XL184 administered daily, and enrollment at this dose level is complete. Due to frequent dose interruptions and reductions, the study was amended earlier this year to initiate a new cohort of patients receiving 125mg. As of October 12, 2009, 38 patients have been enrolled at the 125 mg dose level with 18 patients with at least one IRF read post baseline scan. Tumor response was determined by an independent and blinded radiology facility (IRF) per modified MacDonald criteria. Follow up for the patients receiving 125 mg is relatively short, with the first patient enrolled in late June 2009. Of the 38 patients enrolled at the 125 mg dose level as of October 12, 2009, 18 patients had at least one post-baseline scan available that had undergone IRF evaluation.
Exelixis, Inc. On Track To Meet Prior FY 2009 Financial Guidance
Exelixis, Inc. announced that it is on track to meet its previously stated goals and financial guidance for fiscal 2009. According to Reuters Estimates, analysts were expecting the Company to report revenue of $155. 35 million for fiscal 2009.
