Replies to post #248580 on Avid Bioservices Inc (CDMO)

[pphmtoolong]

cjgaddy, clearly Peregrine management is charging ahead at full speed on Bavituximab.

I hope and believe the BPs are more impressed by this news than the usual handful of traders in PPHM shares.

GLTA, Especially Bavi-arm Sunrise Patients,

Paul

[cjgaddy]

Dr. David Page, mentioned in today's New Bavi-Trials PR re: the upcoming Ph.2 Triple- MBC trial that “originated from Peregrine's ongoing collaboration with Memorial Sloan Kettering” - note Dr. Page's 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”….

From today's (1-11-16) PR, “Peregrine Provides Update on Planned Expansion of Bavi Clinical Pgm in Lung, Breast and Other Cancers”…
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

FROM DR. PAGE's BREAST CANCER RES. FOUNDATION (BCRF) PROFILE:
David B. Page, MD, is a medical oncologist at Providence Portland Medical Center in Portland, Oregon. Dr. Page first became fascinated with cancer biology & immunology as an undergraduate at the Univ. of Chicago and later studied under the mentorship of medical oncologist Dr. Jedd Wolchok, a pioneer in immunotherapy, at Memorial Sloan Kettering Cancer Center. Alongside Dr. Wolchok, Dr. Page treated numerous patients with metastatic melanoma, a usually fatal skin cancer, some who have been cured of cancer and are still living today as a result of immunotherapy. As a fellow, Dr. Page developed several investigator-initiated clinical trials evaluating immunotherapy in breast cancer, including a pilot study...
http://www.bcrfcure.org/researchers/david-page

5-29-15: Peregrine & Sloan Kettering Enter Collab. to “Investigate Novel PS-Targeting Immunotherapy Combos” http://tinyurl.com/qxu4w2x
”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 (Mem.Sloan’s) Dr. Jedd D. Wolchok.

= = = = = = = = = =
1-11-16/PR: Update on 4 New Bavi Clinical Trials (Lung/AZN, Breast/1Co./1MSKCC, Other Cancers/AZN). SUNRISE estimates: Interim1=Early'16, Interim2=Mid'16, FinalUnblinding=End'16… http://tinyurl.com/zhdy37a

9-9-15 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/ph22vdn
...CEO S.King: “The Memorial Sloan Kettering & AstraZeneca collaborations are an important part of our announced plans to expand our bavituximab clinical pgm.”

7-14-15 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/nw2v5u6
...CEO S.King: “We recently entered into collaboration with investigators at Memorial Sloan Kettering Cancer Ctr to continue expanding on this important work, as well as to explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”

[davidal66]

"Peregrine expects that the first interim analysis (33% of targeted number of deaths) will be conducted in early 2016 and the second interim analysis (50% of targeted number of deaths) in mid-2016. The final analysis, which will trigger the unblinding of the study data, is currently projected to occur at the end of 2016. "

I'm new to the stock but have a good understanding of the science. I have a question regarding the first and second interim analysis. On the positive side of the possibilities.... what exactly would trigger an early finish to the trial? in the first or second interim analysis would trigger early termination of the trial(if at all). If a greater amount of deaths occurred in the SOC arm, would the living SOC arm be allowed to take Bavi? Or is the first interim analysis more to ensure the Bavi arm is safe(obviously it is). At 33 % or at 50 % of deaths, if there is enough of a differentiation between the SOC and Bavi arms mortality would the study end? I know this has been discussed already, but I'm trying to wrap my head around what might lead to an early unblinding?

Thanks in advance to anyone who can explain this to me.

[cjgaddy]

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).