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Monday, October 03, 2011 3:58:25 PM
Data for 1st Line NSCLC and HCV Expected Q1’12
2nd Line NSCLC Enrollment Complete by Q4
Cotara® FDA PIII Planning Meeting in Q4
Download Full 43-Page Report with Important Disclosures: PPHM Update 09-28-11 http://lifetechcapital.com/ltc/wp-content/uploads/2011/09/PPHM-Update-09-28-11.pdf
1.) NSCLC & HCV Data Q1’12: Peregrine announced enrollment completion for the 86 patient trial of bavituximab for previously untreated NSCLC in combination with paclitaxel and carboplatin on September 8, 2011. Interim data from this trial is expected Q4 2011 with top-line tumor response data from all 86 patients to follow in Q1 2012. In addition, on September 26, 2011 Peregrine announced complete enrollment of their 66 patient, Phase II trial of bavituximb in combination with ribivirin for the treatment of previously untreated genotype-1 chronic HCV infection. The primary endpoint of the study is the proportion of patients achieving early virologic response (EVR), defined as a greater than or equal to 2 log reduction in HCV RNA after 12 weeks of treatment. Results are also expected by Q1 2012.
2.) Cotara® Phase III Planning: Peregrine reported strong interim overall median survival of 8.8 months (38 weeks) for its Phase II trial of Cotara® for the treatment of recurrent glioblastoma multiforme (brain cancer). This compares favorably to the typical patient prognosis of approximately 6 months at first relapse. Peregine plans to meet with the FDA to discuss the most appropriate Phase III trial plans in Q4 which might be conducted under a Special Protocol Assessment (SPA).
3.) 2nd-Line NSCLC Enrollment to Complete Q4: Peregrine is focusing on 2nd-line treatment of non-small cell lung cancer as their first potentially approvable indication for bavituximab. After suffering enrollment setbacks last quarter, their 120 patient Phase II study of bavituximab in combination with docetaxel in 2nd line NSCLC is now expected to complete enrollment in Q4 2011 with unblinded data in Q2 2012. The trial is currently enrolling at 50 different clinical sites in order to accomplish these targets.
4) Breast Cancer Data: On August 24, 2011 Peregrine reported the top line results from their single arm Phase II study investigating bavituximab in combination with docetaxel for the treatment of refractory advanced breast cancer. The median overall survival was 20.7 months as compared to 11.7 months for metastatic breast cancer patients treated with docetaxel alone in a study cited in the docetaxel package insert. Peregrine is still awaiting the overall survival data for another previous breast cancer single arm Phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel for the treatment of advanced breast cancer. The trial met the primary endpoint of objective tumor response rate with 74% (34 of 46) of patients responding to treatment.
5.) We are maintaining Peregrine Pharmaceuticals with a Strong Speculative Buy rating and 12-18 month price target of $5.00. We continue to believe Peregrine’s anti-phosphatidylserine monoclonal antibody Bavituximab, with dual action against both tumor and viral targets, is a unique and exciting drug candidate in an era of “me-too” drugs and that their Iodine-131 monoclonal antibody Cotara® for glioblastoma also represents a unique approach in a very difficult to treat cancer. Our 12-18 month target price of $5.00 is based on 30x estimated 2015 EPS discounted 50% for cumulative risk. (see Financial Model Assumptions)
Download Full 43-Page Report with Important Disclosures: PPHM Update 09-28-11
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