AI
Thursday, July 18, 2013 11:41:48 AM
Pipeline Chart updated at PeregrineInc.com ~7/18/13. The Ph2 1st-Line/NSCLC & Pancreatic trials have been removed, and the others’ status lines updated.
http://www.peregrineinc.com/pipeline/overview.html
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From the 7-11-13 Financial & Devs PR: http://tinyurl.com/khpokw6
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
• Reached agreement with the U.S. FDA on a Phase III registration trial design of bavituximab in 2nd-Line NSCLC.
• Recently announced final results from its 121 patient Phase IIb randomized, double-blind, placebo-controlled trial of bavituximab in second-line NSCLC at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting [6-3-13: http://tinyurl.com/my8qxw7 ].
? Promising 60% improvement in median overall survival (OS) in the 3mg/kg bavituximab + docetaxel arm compared to the control arm and bavituximab was well-tolerated with no significant differences in adverse events between the trial arms.
? Subgroup analyses of OS by key patient characteristics including age, gender, ECOG status, ethnicity and prior treatment favored the bavituximab 3 mg/kg arm.
• Planning for the initiation of a pivotal Phase III trial by calendar year-end.
OTHER ONCOLOGY INDICATIONS:
• A Phase I IST evaluating bavituximab in combination with paclitaxel in up to 14 patients with HER2-negative metastatic breast cancer. Interim data on 13 evaluable patients were presented at the 2013 ASCO Annual Meeting showed that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response (CR) measured in accordance with RECIST criteria. All patients have been enrolled in this trial.
• A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (liver cancer). The Phase I portion of the trial has completed patient enrollment with enrollment in the Phase II portion of the trial ongoing.
• A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC. This trial continues to enroll and dose patients.
• A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma. This trial continues to enroll and dose patients.
IMAGING PROGRAM HIGHLIGHTS
PS-Targeting Molecular Imaging Program
Peregrine continues to enroll and dose patients in an open-label, single-center trial of its experimental PS-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. The primary goal of the trial is to estimate radiation dosimetry in critical and non-critical organs. Secondary objectives of the trial are tumor imaging and safety. Recently, data were presented from imaging studies demonstrating that the chemotherapeutic drug docetaxel, a commonly prescribed second-line treatment for patients with advanced NSCLC, increases the exposure of bavituximab's target molecule, PS, on tumor blood vessel cells and tumor cells. Results also showed that PS exposure in tumors is correlated with tumor burden and response to docetaxel treatment, supporting exposed PS as a promising biomarker of cancer and response to therapy. In the June 2013 issue of the journal Molecular Imaging, scientists from Peregrine published results from a study showing that PGN650 could be useful in imaging tumors and detect enhanced PS exposure in response to chemotherapy.
http://www.peregrineinc.com/pipeline/overview.html
= = = = = = = =
From the 7-11-13 Financial & Devs PR: http://tinyurl.com/khpokw6
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
• Reached agreement with the U.S. FDA on a Phase III registration trial design of bavituximab in 2nd-Line NSCLC.
• Recently announced final results from its 121 patient Phase IIb randomized, double-blind, placebo-controlled trial of bavituximab in second-line NSCLC at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting [6-3-13: http://tinyurl.com/my8qxw7 ].
? Promising 60% improvement in median overall survival (OS) in the 3mg/kg bavituximab + docetaxel arm compared to the control arm and bavituximab was well-tolerated with no significant differences in adverse events between the trial arms.
? Subgroup analyses of OS by key patient characteristics including age, gender, ECOG status, ethnicity and prior treatment favored the bavituximab 3 mg/kg arm.
• Planning for the initiation of a pivotal Phase III trial by calendar year-end.
OTHER ONCOLOGY INDICATIONS:
• A Phase I IST evaluating bavituximab in combination with paclitaxel in up to 14 patients with HER2-negative metastatic breast cancer. Interim data on 13 evaluable patients were presented at the 2013 ASCO Annual Meeting showed that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response (CR) measured in accordance with RECIST criteria. All patients have been enrolled in this trial.
• A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (liver cancer). The Phase I portion of the trial has completed patient enrollment with enrollment in the Phase II portion of the trial ongoing.
• A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC. This trial continues to enroll and dose patients.
• A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma. This trial continues to enroll and dose patients.
IMAGING PROGRAM HIGHLIGHTS
PS-Targeting Molecular Imaging Program
Peregrine continues to enroll and dose patients in an open-label, single-center trial of its experimental PS-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. The primary goal of the trial is to estimate radiation dosimetry in critical and non-critical organs. Secondary objectives of the trial are tumor imaging and safety. Recently, data were presented from imaging studies demonstrating that the chemotherapeutic drug docetaxel, a commonly prescribed second-line treatment for patients with advanced NSCLC, increases the exposure of bavituximab's target molecule, PS, on tumor blood vessel cells and tumor cells. Results also showed that PS exposure in tumors is correlated with tumor burden and response to docetaxel treatment, supporting exposed PS as a promising biomarker of cancer and response to therapy. In the June 2013 issue of the journal Molecular Imaging, scientists from Peregrine published results from a study showing that PGN650 could be useful in imaging tumors and detect enhanced PS exposure in response to chemotherapy.
