Avid Bioservices Inc (CDMO)

[cjgaddy]

9-7-12: Bavituximab Doubles MOS in 2nd-Line NSCLC, interim n=121 Ph.IIB data presented by Dr. David Gerber at the 2012 Chicago Multidisciplinary Symposium in Thoracic Oncology (ASCO/ASTRO) shows.

This post contains:
• 9-7-12 Press Release recapping Dr. David Gerber’s Plenary talk in Chicago
• 9-7-12 Slides from VP/Clin.Affairs Joe Shan’s 15 min. video recapping Dr. Gerber’s talk
• Comparison data from prev. trials of currently-approved 2nd-Line NSCLC drugs

= = = = = = = = = = = = = = = = = = = = = = =
9-7-12: ”Interim Data from Peregrine's Phase II Trial in Second-Line Non-Small Cell Lung Cancer Demonstrate Doubling of Median Overall Survival in Bavitiximab-Containing Arms”
• Interim Data from Double-Blind, Placebo-Controlled Trial Presented at Late-Breaking Plenary Session at Leading Oncology Symposium
• Data Show Statistically Significant Improvement in Overall Survival for Patients Receiving Bavituximab Plus Docetaxel Versus Docetaxel Alone
• Clinical Data Strongly Support Advancing Program into Phase III Clinical Development
• Company to Host Conference Call on Monday, Sept. 10, at 11:00AM EDT
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=705521

TUSTIN, 9/7/2012: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), today announced that interim results were presented from its 121 patient randomized, double-blind, placebo-controlled Phase IIb trial in patients with refractory non-small cell lung cancer (NSCLC). The blinded study evaluated two dose levels of bavituximab (bavituximab-containing arms) given with docetaxel versus docetaxel plus placebo (control arm). The interim data showed a statistically significant improvement in overall survival (Hazard Ratio 0.524, p-value .0154) and a doubling of median overall survival (OS) in the bavituximab-containing arms compared to the control arm. The following interim data was presented as part of a late-breaking plenary presentation at the 2012 Chicago Multidisciplinary Symposium in Thoracic Oncology by David Gerber, M.D., Associate Professor of Internal Medicine at the University of Texas Southwestern Medical Center, a principal investigator in the trial.



"This study was a rigorous trial designed to minimize bias and we are encouraged that this trial yielded such positive results in the most important endpoint, overall survival. The positive overall response rates and progression free survival in both bavituximab-containing arms seen earlier in the study has now translated into a statistically significant extension in overall survival for patients, a result rarely achieved in phase II clinical trials." said Joseph Shan, VP of clinical and regulatory affairs at Peregrine. "The quality of this data gives us a solid foundation for designing a phase III trial with an increased probability of success. We are planning for an end-of-phase II meeting with the FDA as we plan to initiate this trial by mid-2013."

The trial enrolled 121 patients (117 evaluable per the study protocol) with second-line non-squamous NSCLC following one prior chemotherapy regimen at over 40 clinical centers. Patients were equally randomized to 1 of the 3 treatment arms, docetaxel (75mg/m2) plus either placebo, 1 mg/kg bavituximab, or 3 mg/kg bavituximab until disease progression. Approximately 50% of the patients were enrolled in the U.S. and 50% were enrolled internationally with equal distribution between all treatment groups.

"Robust data from this Phase II trial clearly demonstrate a significant benefit in overall survival with a good safety profile in patients receiving bavituximab plus docetaxel compared to those receiving docetaxel plus placebo," said Steven W. King, president and CEO of Peregrine. "We are currently in discussions with several potential pharmaceutical partners who have expressed great interest in our bavituximab oncology program. It is our goal to identify the optimal partner to assist with the design and logistics of a multinational Phase III pivotal trial."

The interim results from the study showed no significant safety differences between the three treatment arms as determined by the trial's independent data monitoring committee. Baseline characteristics were well balanced across all three treatment arms of the study, including performance (ECOG) status, age, gender, and race. Tumor responses were determined in accordance with Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on blinded central radiology review.

"The median overall survival [MOS] results from the Proof-of Concept study are truly outstanding and great news for patients. Statistically significant overall survival results at this stage of development are rare and have put us in an excellent position for advancing the program. Our attention is now turned to an end of phase II meeting by year end which will help us define the most efficient path forward to potential regulatory approval," said Robert Garnick, PhD, Head of Regulatory Affairs at Peregrine. "A global Phase III trial designed very similarly to the robust design of this Phase II trial greatly increases bavituximab's likelihood of success."

AUDIO WEBCAST
In conjunction with Dr. Gerber's presentation in Chicago, Peregrine has posted an audio webcast and slide deck to Peregrine's website. The webcast will be hosted by Joseph Shan, VP of clinical and regulatory affairs. This event will be pre-recorded. Access to the audio and corresponding slides can be found on Peregrine's website [ http://www.peregrineinc.com ].

CONFERENCE CALL
Peregrine will host a conference call and webcast to discuss these data and financial results for the first quarter fiscal year 2013 on Monday, Sept. 10, 2012, at 11:00 AM ET (8:00 AM PT). To listen to the conference call, please dial [phone] or [phone] and request the Peregrine Pharmaceuticals call. A replay of the call will be available starting approximately two hours after the conclusion of the call through September 24, 2012 by calling [phone], or [phone] and using passcode 27367274.

ABOUT LUNG CANCER
According to the American Cancer Society, lung cancer is the second most commonly diagnosed cancer in the U.S., with approximately 226,160 new cases and 160,340 deaths each year, representing approximately 28% of all cancer deaths. NSCLC is the most common type of lung cancer, accounting for approximately 85-90% of lung cancer cases. Unfortunately, the 5-year survival rate for NSCLC patients is only 1%.

ABOUT BAVITUXIMAB
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. Bavituximab is the lead drug candidate from the company's PS technology platform and is currently being tested in eight clinical trials including three randomized Phase II trials in front-line and second-line non-small cell lung cancer, front-line pancreatic cancer and five investigator-sponsored trials (ISTs) in additional oncology indications.

PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor.

ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Contact: Christopher Keenan or Jay Carlson - Peregrine Pharmaceuticals, Inc., [phone], [e-mail]

= = = = = = = = = = = = = = =
VP Joe Shan’s 9-7-12 15min. Audio Webcast recapping Dr. David Gerber’s 2nd-Line NSCLC Interim Data Presentation on 9-7-12 at the ASTRO-ASCO Thoracic-Oncology Symposium in Chicago ( http://clinicaltrials.gov/ct2/show/NCT01138163 ):
“In conjunction with Dr. Gerber's presentation in Chicago, Peregrine has posted an audio webcast and slide deck to Peregrine's website. The webcast will be hosted by Joseph Shan, VP of Clinical & Regulatory Affairs. This event will be pre-recorded. Access to the audio & corresponding slides can be found on Peregrine's website.”
• Access replay here: http://www.peregrineinc.com
• Or directly: http://www.peregrineinc.com/nsclc-presentation-astro-9-7-12.html?tmpl=video



9-7-12 Joe Shan Slideshow (Dr. Gerber’s 9-7-12 ASTRO/Chicago Bavi 2nd-Line NSCLC Interim Data):





















From the 9-7-12 Press Release:


= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Per Cancer.gov (NCI) - last modified: 8/15/2012…
Std. treatment options for Recurrent NSCLC include the following:
Chemotherapy or kinase inhibitors alone, including the following for patients who have previously received platinum chemotherapy:
• Taxotere (docetaxel) => MOS=6.3mos (meta-analysis of 5 trials, 865 pts)
• Altima (pemetrexed) => No diff. vs. Docetaxel (Ph.3 non-inferiority vs. Doce, 571 pts)
• Tarceva (erlotinib) => MOS=5.3mos (TITAN** Ph.III n=424 trial – see http://tinyurl.com/8w8lo93 )
• Iressa (gefitinib) => “Iressa does not improve OS”
• Xalkori (crizotinib) => very limited, only for ALK-positive pts (2-7% of pop.)
http://www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-lung/healthprofessional/page12
- - - - - - - -
NOTE 10-8-08: “2nd-Line NSCLC: Avastin/Tarceva Improves PFS but Not Overall Survival vs. Tarceva” ( http://cancergrace.org/lung/2008/10/08/beta-neg-for-os )
** "The TITAN (Tarceva) study (treatment 4/2006-2/2010) is the first prospective head-to-head study to specifically investigate Tarceva (erlotinib) vs. systemic chemotherapy in 2nd-Line NSCLC for patients who progressed during 1st-line platinum-doublet chemotherapy.”
http://www.egfr.roche.es/TITAN/TITAN_EMCTO_Poster.pdf

= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
F. LEAD IND: Phase IIb Bavi+Doce vs. 2nd-Line NSCLC (randomized, double-blinded, placebo-ctl'd, n=120, 'registrational')
Protocol: http://clinicaltrials.gov/ct2/show/NCT01138163 (24 U.S. + 15 India + 2 RepGA + 7 RussianFED + 5 Ukraine = 53 as of 8-12-11)
Enrolled Oct2010 - Oct2011 at 40 global sites (per J.Shan 9-7-12 webcast ( http://tinyurl.com/8cn87la )
8-2012: Compare Bavi+Doce's MOS=13.1mos (Bavi/3mg) to the 4 Curr-Approved 2Line/NSCLC Drugs http://tinyurl.com/cgnkvpa
• Taxotere/docetaxel => MOS=6.3mos (meta-analysis of 5 trials, 865 pts)
• Altima/pemetrexed=> No diff. vs. Docetaxel (Ph.3 non-inferiority vs. Doce, 571 pts)
• Tarceva/erlotinib => MOS=5.3mos (TITAN Ph.III n=424 trial - see http://tinyurl.com/8w8lo93 )
• Iressa/gefitinib=> "Iressa does not improve OS"
…9-10-12 CEO Steve King, QtlyCC ( http://tinyurl.com/8nkwrml )
……"These are truly remarkable results (statistically doubling MOS) that are not only great for the pgm… but also great news for the NSCLC patients in the trial…"
…9-10-12 Robert Garnick (Head/Reg), QtlyCC ( http://tinyurl.com/8nkwrml )
……"The NSCLC data we announced 9-7-12 has far exceeded our expectations, and I hope that you're as excited as I am with bavituximab's potential. I feel strongly that Peregrine should be recognized for having the corporate courage to conduct the rigorous, randomized placebo-controlled Phase II trial that provided these robust data and that provide the basis for us to plan for a pivotal Phase III program."
...9-7-12: PPHM Press Release about Dr. Gerber's plenary at ASTRO/Thoracic/Chicago: http://tinyurl.com/8oxwk6v
…"The interim data showed a statistically significant improvement in OS (Hazard Ratio 0.524, p-value .0154) and a doubling of MOS (12.1/13.1mos. vs. 5.6mos.) in the Bavituximab-containing arms compared to the [Docetaxel] ctl-arm."
......VP Joe Shan's 15min. Webcast & Slideshow recapping Dr. David Gerber's 9-7-12 ASTRO/Chicago Plenary: http://tinyurl.com/8cn87la
…8-15-12 CEO Steve King, Wedbush/NYC ( http://tinyurl.com/8mhrtld )
......"As we're sitting here today, we have still not reached the # of events for MOS in either of the Bavituximab arms - and, in fact, we still have patients that are on treatments." Q&A: "it's going to be a very positive MOS result, it's just a matter now of magnitude."
…7-16-12 CEO Steve King, QtlyCC ( http://tinyurl.com/cs7spbz )
......"The strength of this 2nd-Line NSCLC data (esp. MOS trends) in this large area of high unmet medical need has also sparked a surge in partnering discussions that has included over 15 in-person partnering meetings since that time with major players in oncology, with all discussions ongoing and addl. parties showing interest. Our goal for the program is to position ourselves, along with a potential partner, to initiate Ph3 by mid-2013, which means an EOP2 meeting by yr-end'12. It would be ideal to have a partner on board to participate in the EOP2 meeting, and we have communicated this to interested parties and they agree."
…7-16-12 Robert Garnick (Head/Reg), QtlyCC ( http://tinyurl.com/cs7spbz )
……"We've been working very hard and very actively on the next steps in our Bavi 2nd-Line NSCLC pgm, given the favorable data that we've seen. As you can imagine, with data like this, there are many things that we need to consider. One consideration is that, should the data continue to trend the way it is, particularly in survival, this opens a door for potential discussions around a pathway for Accelerated Approval. At this point, all options are being considered, with Peregrine working towards the most efficient path forward from a regulatory standpoint." Q&A: "…all in all, I think the data is extremely compelling and I think it makes a really good case. Certainly, I think, I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing a meeting with the FDA for Q4'12."
…7-12-12 CEO Steve King, JMP-Conf/NYC ( http://tinyurl.com/csdclwb )
……"Re: 2nd-Line/NSCLC trial, the most thrilling thing is the fact that, even though we'd reached MOS for the ctl-arm(Doce) at end of Apr'12 of LESS THAN 6MOS, the majority of patients are still alive (today) in both Bavi arms, and we expect that to continue for some period of time still. Ph3 planning is underway already; our goal is to start this Ph3 by mid'13, meaning an EOP2 meeting with the FDA in Q4'12; our goal is to bring a partner on board, ideally in time for that EOP2 meeting, certainly before the beg. of the Ph3 trial."
…5-21-12: TopLine data n=117 for Bavi/3mg+Doce arm: ORR=17.9%/PFS=4.5mos (vs. CTL 7.9%/3mos) http://tinyurl.com/73aeyxj
......Importantly, MOS for CTL-arm "< 6 mos", but not yet reached in both Bavi arms.
...10-6-11: Enrollment complete. http://tinyurl.com/3m9re39
...7-14-11/CC: Enrollment was taking longer than expected; have amended protocol; expanding to ~45 sites, expect enroll. comp. "early in Q4/2011", data unblinding 1H'12. http://tinyurl.com/6k6y2as
…3-17-10/Roth, CEO S.King: "We refer to this trial as a Registrational Phase II Study, because we believe that if we have results anywhere near approaching what we saw in the earlier [India] study, it could be a conduit for Accelerated Approval."
...6-4-10: Ph.2b randomized reg. trial Open for enrollment: http://tinyurl.com/25v22qk
……"up to 120 refractory patients at ~30 clinical sites; goal: fully-enroll by mid'11, topline data by y/e'11."