Avid Bioservices Inc (CDMO)

[biopharm]

Chemotherapies/Inhibitor combinations with Bavituximab :

Concentrating on "Sorafenib" for now ... but have listed several others.

Adding Sorafenib to the list now as trial data results may be released soon. Sorafenib is already approved for Renal Cancer (US-2005 & EU-2006) and advanced liver cancer (US/EU-2007). These results will allow us to assess how Bavituximab + Sorafenib actually compares to Sorafenib alone? Bavituximab has been proven to work with many chemos already.

The current trial of Bavi + Sorafenib is a single institution trial University of Texas at Southwestern Medical and if results top those of Sorafenib alone... as its already FDA approved in the US/EU for liver cancer: Onyx clearly would have a decision to make .... because if these results are "over the top" ... that just may be the initial indication that it may be the perfect 1..2 punch for several other future trials in many other hard to treat indications.

This is why the buyout offers for Onyx came in on a moments notice last weekend for $120 per share! ... as Peregrine sits around $1.45. Bavituximab is unique in the way it targets the "outer" flipped Phospatidylserine (PS) and never needs to "enter" the cell to perform its MOA, as many other drugs need to "break" and "enter" the cell which is the reason for many side affects. Partnerships are pushed along due to a drug that works... will get pushed along even faster with a drug that works well in several indications... and yes, can get pushed along ever faster! if the drug works well in several indications "and" a safety profile unmatched by many other oncology drugs and the FDA would like that! The safety profile of Bavituximab is key as it mixes well with many combinations and here is a short list that have been put to the test with Bavituximab.

1) Sorafenib (Nexafar) - Bayer/Onyx IST Liver Cancer

http://clinicaltrials.gov/show/NCT01264705


2) Docetaxel - Sanofi Phase IIb 2nd line NSCLC

http://clinicaltrials.gov/ct2/show/NCT01138163?term=bavituximab&rank=7


3) Carboplatin - BMS 1st line NSCLC Both Trial Arms
4) Paclitaxel - BMS 1st line NSCLC **14+ months**

http://clinicaltrials.gov/ct2/show/NCT01160601?term=bavituximab&rank=6

http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=774172


5) Gemcitabine (Gemzar)-Eli Lilly IST Pancreatic

http://clinicaltrials.gov/ct2/show/NCT01272791?term=bavituximab&rank=1


6) Pemetrexed (Amtil)-Eli Lilly IST 1st line NSCLC

http://clinicaltrials.gov/ct2/show/NCT01323062?term=bavituximab&rank=12

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1) Sorafenib

Sorafenib (co-developed and co-marketed by Bayer and Onyx Pharmaceuticals as Nexavar),[1] is a drug approved for the treatment of primary kidney cancer (advanced renal cell carcinoma) and advanced primary liver cancer (hepatocellular carcinoma).

http://en.wikipedia.org/wiki/Sorafenib
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2) Docetaxel

The one I missed off the original list... though probably the most newsworthy as it is now part of Peregrines Phase III NSCLC upcoming trial.

The original Phase IIb NSCLC displayed a 109% MOS improvement and later revised down to a still historical 60% MOS improvement! This was caused by the 3rd party "dose switching" of the placebo and 1mg Bavi arm as the 3mg Bavi arm was not affected. Revising the MOS improvement down from 109% to 60% was only due to the "combination" of the placebo and 1mg Bavi arms -- vs -- the higer dose 3mg Bavi arm.

Note: This clearly shows that without the 3rd party mistake ("clear evidence of dose switching")... the originally reported 109% MOS improvement would have been higher! I believe this makes Sanofi a suitor in partnering talks as well since they know exactly the benefit that Bavituximab gave in combination with Docetaxel (along with many other Big Pharma and the FDA)

http://en.wikipedia.org/wiki/Docetaxel
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3) Carboplatin

Discovered at Michigan State University,[2] and developed at the Institute of Cancer Research in London. Bristol-Myers Squibb gained Food and Drug Administration (FDA) approval for carboplatin, under the brand name Paraplatin, in March 1989. Starting in October 2004, generic versions of the drug became available.

http://en.wikipedia.org/wiki/Carboplatin
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4) Paclitaxel

A mitotic inhibitor used in cancer chemotherapy. It was discovered in a US National Cancer Institute program at the Research Triangle Institute in 1967 when Monroe E. Wall and Mansukh C. Wani isolated it from the bark of the Pacific yew tree, Taxus brevifolia and named it taxol. Later it was discovered that endophytic fungi in the bark synthesize paclitaxel.

When it was developed commercially by Bristol-Myers Squibb (BMS), the generic name was changed to paclitaxel and the BMS compound is sold under the trademark Taxol. In this formulation, paclitaxel is dissolved in Cremophor EL and ethanol, as a delivery agent. A newer formulation, in which paclitaxel is bound to albumin, is sold under the trademark Abraxane.

Paclitaxel is used to treat patients with lung, ovarian, breast, head and neck cancer, and advanced forms of Kaposi's sarcoma. Paclitaxel is also used for the prevention of restenosis.

Paclitaxel stabilizes microtubules and as a result, interferes with the normal breakdown of microtubules during cell division. Together with docetaxel, it forms the drug category of the taxanes. It was the subject of a notable total synthesis by Robert A. Holton.

While offering substantial improvement in patient care, paclitaxel has been a relatively controversial drug. There was originally concern because of the environmental impact of its original sourcing (no longer used) from the Pacific yew. In addition, the assignment of rights to Bristol-Myers Squibb, and even the name itself, were the subject of public debate and Congressional hearings.

http://en.wikipedia.org/wiki/Paclitaxel
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5) Gemcitabine

Gemcitabine (pronunciation: jem-SITE-a-been) is a nucleoside analog used as chemotherapy. It is marketed as Gemzar by Eli Lilly and Company.

http://en.wikipedia.org/wiki/Gemcitabine
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6) Pemetrexed

The molecular structure of pemetrexed was developed by Edward C. Taylor at Princeton University and clinically developed by Indianapolis based drug maker, Eli Lilly and Company in 2004.

Pemetrexed is chemically similar to folic acid and is in the class of chemotherapy drugs called folate antimetabolites. It works by inhibiting three enzymes used in purine and pyrimidine synthesis—thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase[1][2] (GARFT). By inhibiting the formation of precursor purine and pyrimidine nucleotides, pemetrexed prevents the formation of DNA and RNA, which are required for the growth and survival of both normal cells and cancer cells.

http://en.wikipedia.org/wiki/Pemetrexed
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