AI
Thursday, February 18, 2016 10:41:12 AM
Bavi+Taxol MSKCC/Collab. Triple- Breast Cancer Ph2 Trial hits ClinicalTrials.gov: n=42, Start=Mar.2016
“A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early-Stage Triple- Negative Breast Cancer – Ph.2”
http://clinicaltrials.gov/ct2/show/NCT02685306 (rec. 2-2-16, upd. 2-12-16)
PURPOSE: The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug taxane, will improve the results of the treatment for early-stage Triple Negative Breast Cancer followed by Standard-of-Care surgery
Est. Enrollment: 42
Start Date: March 2016
Est. Study Completion Date: Sept 2017
Est. Prim. Comp. Date: April 2017 (Final data collection date for primary outcome measure)
PI: David Page, MD - Providence Portland / Robert W. Franz Cancer Res. Center
Est.Init Q1/2016: Ph2, Bavi+Paclitaxel(Taxol), Early Stage Triple- Breast Cancer (TNBC), (randomized, open-label, ~27pts), "originated from Peregrine's ongoing collab. with MSKCC" http://tinyurl.com/zhdy37a
= = = = = = = = = = = = = = = = = = = = = = = = = =
1-11-16 PR, “Peregrine Provides Update on Planned Expansion of Bavi Clinical Pgm in Lung, Breast and Other Cancers”… http://tinyurl.com/zhdy37a
PLANNED TRIALS...
#4. Phase II Trial in Early Stage TNBC in Combination with Chemotherapy
Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page, M.D., at the Providence Cancer Center in Oregon. http://tinyurl.com/zhdy37a
- - - - - - - -DR. DAVID PAGE: note his prior work with Dr. Jedd Wolchok, chief of Mem.Sloan's Melanoma & Immunotherapeutics Service who “investigates novel approaches for cancer immunotherapy and mechanisms of tumor cell–immune cell interactions”… http://www.bcrfcure.org/researchers/david-page
5-29-15: Peregrine/MSKCC Collab. Announced: http://tinyurl.com/zkvebh6
“The studies at MSK will be performed under the direction of Taha Merghoub, PhD, [ http://www.mskcc.org/research-areas/labs/members/taha-merghoub-01 ] Associate Attending Biologist, Melanoma and Immunotherapeutics Service, Ludwig Collaborative and the Swim Across America Laboratory, a part of the laboratory of Jedd D. Wolchok, MD, PhD [ http://www.mskcc.org/research-areas/labs/jedd-wolchok ], a leader in the field of cancer immunotherapy. Dr. Wolchok serves as the Chief, Melanoma and Immunotherapeutics Service, Lloyd J. Old Chair for Clinical Investigation as well as an Associate Director of the Ludwig Center for Cancer Immunotherapy at MSK.”
"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said Dr. Jedd Wolchok (MSKCC).
"A key focus of the Wolchok Lab's research is studying novel immunotherapy combinations that work together to enable the immune system to recognize and destroy cancer. This collaboration will allow us to focus on the role and contribution of PS blockade therapy in determining which combination of the current and next generation of immune modulators is likely to increase the extent and amplitude of anti-tumor response. This important pre-clinical and translational work will potentially guide the design of the next generation of clinical studies with bavituximab," said Dr. Taha Merghoub (MSKCC).
“A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early-Stage Triple- Negative Breast Cancer – Ph.2”
http://clinicaltrials.gov/ct2/show/NCT02685306 (rec. 2-2-16, upd. 2-12-16)
PURPOSE: The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug taxane, will improve the results of the treatment for early-stage Triple Negative Breast Cancer followed by Standard-of-Care surgery
Est. Enrollment: 42
Start Date: March 2016
Est. Study Completion Date: Sept 2017
Est. Prim. Comp. Date: April 2017 (Final data collection date for primary outcome measure)
PI: David Page, MD - Providence Portland / Robert W. Franz Cancer Res. Center
Est.Init Q1/2016: Ph2, Bavi+Paclitaxel(Taxol), Early Stage Triple- Breast Cancer (TNBC), (randomized, open-label, ~27pts), "originated from Peregrine's ongoing collab. with MSKCC" http://tinyurl.com/zhdy37a
= = = = = = = = = = = = = = = = = = = = = = = = = =
1-11-16 PR, “Peregrine Provides Update on Planned Expansion of Bavi Clinical Pgm in Lung, Breast and Other Cancers”… http://tinyurl.com/zhdy37a
PLANNED TRIALS...
#4. Phase II Trial in Early Stage TNBC in Combination with Chemotherapy
Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page, M.D., at the Providence Cancer Center in Oregon. http://tinyurl.com/zhdy37a
- - - - - - - -DR. DAVID PAGE: note his prior work with Dr. Jedd Wolchok, chief of Mem.Sloan's Melanoma & Immunotherapeutics Service who “investigates novel approaches for cancer immunotherapy and mechanisms of tumor cell–immune cell interactions”… http://www.bcrfcure.org/researchers/david-page
5-29-15: Peregrine/MSKCC Collab. Announced: http://tinyurl.com/zkvebh6
“The studies at MSK will be performed under the direction of Taha Merghoub, PhD, [ http://www.mskcc.org/research-areas/labs/members/taha-merghoub-01 ] Associate Attending Biologist, Melanoma and Immunotherapeutics Service, Ludwig Collaborative and the Swim Across America Laboratory, a part of the laboratory of Jedd D. Wolchok, MD, PhD [ http://www.mskcc.org/research-areas/labs/jedd-wolchok ], a leader in the field of cancer immunotherapy. Dr. Wolchok serves as the Chief, Melanoma and Immunotherapeutics Service, Lloyd J. Old Chair for Clinical Investigation as well as an Associate Director of the Ludwig Center for Cancer Immunotherapy at MSK.”
"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said Dr. Jedd Wolchok (MSKCC).
"A key focus of the Wolchok Lab's research is studying novel immunotherapy combinations that work together to enable the immune system to recognize and destroy cancer. This collaboration will allow us to focus on the role and contribution of PS blockade therapy in determining which combination of the current and next generation of immune modulators is likely to increase the extent and amplitude of anti-tumor response. This important pre-clinical and translational work will potentially guide the design of the next generation of clinical studies with bavituximab," said Dr. Taha Merghoub (MSKCC).
