Recent PPHM prelim results re. Bavituximab/chemo combination therapy for solid cancers showed efficacy equal to Avastin, and no clear-cut superiority, a perplexing result in that we know the FDA likes new drugs to demonstrate clear-cut advantage over existing treatment. Do the results kill Bavi and PPHM? Doubtful. Instead they suppport important new perspectives for the investment and scientific communities re ongoing support options and strategy.
Bavi will obviously be used, or a Bavi-like MAB. Ideally Bavi or its offspring will be a preventative taken in a capsule, and the "preventive mode" for healthcare in US, although severely limited, is gaining momentum. Preventive medicine today is mostly launched on an large scale only when epidemiology police shout "Epidemic!"
In years to come Bavi will be administered early in disease to stimulate the immune system, and to increase the efficiency of the entire immune system. It "unblocks" the immune system in part by calling to the disease scene the body's own killer-cells trained to attack cancers and virally infected cells, various antibodies (ABs).
At first it was thought that endothelial cells of blood vessels nourishing cancers were the only cells with the ability to invert a part of their outer wall, a process similar to selective bricks in a wall doing an about face, turning inside out. Later it was noted that components (bricks) in cell walls of cancer cells, and also cells infected by viruses, also turn inside-out. The wall components, or bricks, are actually several different fat compounds with attached phosphates, and many different types are capable of the inside-out-turning.
The phospholipid brick studied more than any other is phosphatidylserine(-PS), but other similar phospholipid bricks have similar properties, such as phosphatidyl-choline and -inositol, to mention only two. So cancer cells and virally-infected cells invert their cell walls....turn a cell wall component inside-out, and one of the bricks in the cell wall is -PS.
PPHM scientists genetically engineering a missile that homes-in on -PS, phosphatidyl serine, one of the phospholipid bricks that rotates inside-out, and the resulting missile now in production and in human trials is Bavituximab, or Bavi. The missile is a "monoclonal" antibody (mAB)with two arms, one capable of homing-in and grabbing onto cell surface brick -PS, and the other capable of carrying a payload of anti-cancer molecules which are hurled into or onto tumor surface.
In this recently reporte Phase II trial Bavi showed safety and efficacy when combined with chemotherapy despite patient advanced tumors and depleted immune systems. Important, Bavi did not cause serious side-effects in this cohort of immunologically- wasted patients.
PPHM stock price would have reacted more favorably to results of a Bavi/irradiation combination therapy trial. But that trial remains for the future. Why Bavi + Irradiation? Because co-treatment with chemotherapy interferes with Bavi efficacy. And it is now know that Bavi enhances the effects of irradiation treatment much more than it enhances chemotherapy treatment.
The mistake was made. We move on. Despite a few goofs Bavi is still playing in the big leagues, and with no flashy bankrolls or high flying stock prices to hedge critical results of multiple human trials. While the number of publications re. anti-phospholipids mushrooms geometrically in the medical literature, PPHM stockholders sweat over downward drifting stock price and the threat of NSDQ delisting and stock reverse-split.
The Phase II Bavi/chemotherapy report indicates that Bavi is probably equal to Avastin in "time to recurrence" in "hopeless" cases with advanced disease, and more important, is probably superior to Avastin in safety. The best next step, one that for reasons of medical economics and politics should be taken quickly, is combined Bavi- and Avastin, and DNA-Roche (Europe) should finance trials.
Where is China in all this? Will its giganza MAB manufacturing facilities receive FDA certification? Is it in China's interest to stall until their MAB production facilities have the secrets and certificates? What about Cotara in China?
PPHM has an FDA-approved MAB production facility, Avid, capable of brewing batches of Bavi, and a laboratory team capable of the complicated technique of synthetizing Bavi and almost any other MAB. PPHM has the capability of building designer missiles for other biotechs, or supporting their own current human MAB trials.
The question is not WHETHER Bavi, but how to unblock the system and move Bavi along quickly. And how to profit from the burgeoning field without getting in its way...or its own. and how to avoid being gobbled up, in part or whole, for a fraction of its true value. The combination of DNA-Roche and PPHM seems an inevitability and the greatest hope for moving forward rapidly. Foundation money from the likes of the Gates Foundation help. So do government contracts. But the investment community, through motivated corporate employees, not the Federal government or a foundation, will provide the most profit for PPHM and its stockholders.
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