Avid Bioservices Inc (CDMO)

[cjgaddy]

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://tinyurl.com/8oxwk6v & 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



Selected Slides:





















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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 Sites: 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 )
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8-2012: Compare Bavi+Doce's projected MOS=12+mos 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"
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...9-7-12: 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 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."

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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
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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 = http://tinyurl.com/8lfbrrs

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PR 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
FULL PR: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79350388