Saturday, January 26, 2013 9:35:55 AM
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1-25-13: MLV's George Zavoico recaps 2L/NSCLC data errors & current status of PPHM’s review…
......GZ: ”This means that patients randomized into the high dose arm were administered Bavi correctly, whereas some of the patients in the placebo arm were administered low dose Bavi and some in the low dose Bavi arm were administered placebo. More importantly, the findings suggested that the MOS of 13.1 mos. in the high dose arm was likely to be valid. Even by historical measures, this is a remarkable result, since docetaxel's product insert lists the MOS of NSCLC patients receiving this widely used drug as 2nd-Line therapy in 2 trials as 5.7 & 7.5 mos. In effect, adding Bavi doubled the MOS. In our view, this was an extraordinary stroke of luck. If the high dose arm had been affected by the coding discrepancy, Peregrine would have been in a completely different & unfortunate position…
Moreover, Peregrine must determine how best to present its case to the FDA. Will the historical controls be sufficient to justify moving Bavi into a Phase III pivotal trial, or will Peregrine have to pool the results of the placebo & low-dose arms and use that as a comparator to argue for moving ahead? A simple average of the placebo & low-dose arms results in a new control MOS of about 8.4 mos., still several months less than that of the high dose arm. This quick analysis results in about a 5-mo. survival advantage, a substantial prolongation for patients with second-line NSCLC and likely to justify moving Bavi into a pivotal Phase III trial in 2013, in our view.”
http://www.benzinga.com/analyst-ratings/analyst-color/13/01/3275311/peregrine-pharmaceuticals-finds-its-stride-again-exclusi
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Also, in the 1-25-13 Benzinga interview, MLV's George Zavoico begins with the simple, layman’s overview of Bavi’s MOA:
GZ 1-25-13: “Bavituximab is an unusual therapeutic antibody in that it does not target a protein or peptide, but a structural cell membrane phospholipid called phosphatidylserine, or PS. For decades, PS was thought to have only a structural role; helping to maintain the integrity of the cell membrane. However, it is now understood that PS is a marker of stressed, injured or dying cells undergoing apoptosis. Included in this category are tumor cells and vascular endothelial cells lining blood vessels of tumors stressed by hypoxia or acidity. Healthy cells expend a considerable amount of energy sequestering PS to the inner leaflet of their cell membrane bilayer, keeping it largely invisible to the extra-cellular environment. When PS flips over to the outer leaflet in injured or dying cells, it is now exposed and serves to mark the cell for disposal without initiating an inflammatory or immune response. The anti-inflammatory & immunosuppressive effects of PS flipping and exposure enables efficient removal of injured and dying cells by phagocytes without affecting healthy bystander cells. Notably, tumors hijacked this immunosuppressive function to avoid detection and their own removal. By binding to PS exposed on tumors & tumor vasculature, bavituximab serves to identify cells for disposal by antibody-dependent cell-mediated cytoxicity (ADCC) by effector cells of the immune system and by reversing the tumor's immunosuppressive effects. Thus, PS is a selective, non-protein therapeutic target, which differentiates bavituximab from other antibody therapeutics.”
http://www.benzinga.com/analyst-ratings/analyst-color/13/01/3275311/peregrine-pharmaceuticals-finds-its-stride-again-exclusi
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1-7-13 PPHM PR: Review Update: "discrepancies are isolated to the placebo and 1 mg/kg arms; no evidence of discrepancies in the 3 mg/kg arm… Peregrine is taking a very conservative approach toward analyzing the results by combining the placebo & 1mg/kg arms into one treatment arm (control arm), and comparing to the 3mg/kg arm. This analysis indicates that the 3 mg/kg arm continues to show favorable TRR's, PFS, and OS over the new combined control arm. Peregrine expects to announce more detailed results from the analysis in the near term when it is completed… ‘The results from this comprehensive review have provided a better understanding of the outcome of this trial. We believe that these results of our internal review & subsequent data analysis support advancing bavituximab into Phase III development for the treatment of 2nd-Line NSCLC,’ said Joseph Shan, VP/Clinical & Regulatory Affairs of Peregrine. ‘We are now preparing for discussions with the FDA and worldwide regulatory agencies.’" http://tinyurl.com/asup54d
9-24-12: Major Discrepancies found in 2nd-Line NSCLC Ph.2B Treatment Group Coding by Indep. Third-Party Vendor (CSM, Fargo ND) http://tinyurl.com/8r9zcqy
1-17-13: Peregrine's lawsuit against CSM for "breach of contract & negligence" SERVED http://tinyurl.com/bgnzzwl
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