Avid Bioservices Inc (CDMO)

[cjgaddy]

And further explained by Dr. Garnick on 7-14-10...

7-14-10 CC: ( http://tinyurl.com/3a4p66c )
DR. ROBERT GARNICK (Head/Regulatory Affairs):
"Thanks, Steve. Since I joined Peregrine last year, I’ve worked closely with the team here to develop a comprehensive clinical, regulatory, and manufacturing strategy for bavituximab, similar to what I used successfully for Avastin while I was at Genentech. And as you know, Avastin was the first broad-spectrum anti-cancer agent, and in my mind bavituximab could be potentially very similar to Avastin because of the broad presence of bavituximab phosphatidylserine target in numerous cancers.

We designed this comprehensive regulatory strategy to take advantage of the previous signal-seeking Phase II trials completed by Peregrine in order to design a regulatory strategy for bavituximab that could lead to a rapid regulatory approval. This strategy, which I again used successfully at Genentech for Avastin and Rituxan, targets a first approval in the refractory disease setting, followed by an approval in the frontline setting, which as you all know is much more difficult.

In addition, we are initiating a number of investigator sponsored signal-seeking trials, or ISTs, to further develop bavituximab as a broad spectrum agent similar to Avastin. In order to execute this strategy, we initiated a Phase IIb refractory NSCLC trial in June of this year, and today announced a Phase IIb trial in frontline NSCLC cancer.

As I described previously, our first approach for approval for bavituximab is a proof of concept refractory NSCLC trial. We are pursuing the refractory disease setting as it is a high unmet medical need, and potentially the fastest route for FDA approval. An excellent recent example of this strategy is that last week Genentech submitted a BLA for Herceptin DM1. This application was based on a single-arm Phase II trial in 110 patients with HER2+ breast cancer with failed previous therapies. Genentech trial measured an objective response rate as the primary endpoint.

Clearly, there is a regulatory pathway for bavituximab if the data from our refractory Phase IIb trial are exceptional. In drug development, well-designed trials have the potential to generate exceptional data, and we need to be prepared to file for Accelerated Approval if we hit the home run scenario. I should point out that if the data from this trial aren’t a home run, but still positive, which is the more likely outcome, we would plan to conduct an addl. Phase III trial to pursue the refractory NSCLC indication for bavituximab.

A third critical aspect of our clinical, regulatory and mfg. strategy is that Peregrine has the major advantage of having its own clinical product manufacturing capability in Avid. While simultaneously developing the regulatory & clinical strategy I just outlined, we also over the last 9 mos. have put significant effort into increasing our manufacturing capability for bavituximab. This capability is now sufficient to support an early approval if we’re lucky enough to be in that situation [see 5-3-10: PPHM leases addl. 11,000sq of adjacent space (Avid exp?): http://tinyurl.com/2eu6zm6 ].

I’m very excited about the opportunity to execute this comprehensive strategy and feel fortunate to have the opportunity to work on a 2nd broad-spectrum agent such as bavituximab.

At this point, I would like to just turn your attention for a moment to our 2nd anti-cancer drug, Cotara. As you know, we’re currently completing the Phase II trial of this product in recurrent glioblastoma multiforme (GBM), and expect to have an end of Phase II meeting with the FDA early next year as soon as these data are available, and then be able to effectively plan our Phase III approval strategy.

I like to end by again saying how optimistic I am about bavituximab’s potential. The growing body of research points to bavituximab potentially providing a unique & valuable new approach for the treatment of cancer. The clinical results we have to date support moving forward with our regulatory strategy to advance this novel antibody. I will now turn the call over to Joe Shan for an update on our clinical programs designed to support the comprehensive strategy I have just outlined."