Fax- When it comes to Bavi AV vs. Bavi AC, I am presuming that the overall mass of inverted PS will be much greater for cancer/tumors than for viruses. The method of operation of Bavi working in concert with the immune system may equalize that mass difference, but would it not make sense that Bavi AC would need a larger dose than Bavi AV? I consider that PPHM has said that safety of Bavi is being investigated with the Hep C trials and cander trials for both the prospective applications to other viral indications and cancer. That suggests administration of Bavi for the HCV trial may be designed to seek safety data for doses higher than that just needed to treat HCV.
My layman's knowledge about Hep C is that it can be difficult to treat because residual virus can be in parts of the body not benefiting from service by large quantities of blood flow. An antiviral circulating in the bloodstream may be depleted before reaching all the HCV, allowing the residual virus to replicate and reestablish itself throughout the body. Correct or not, the method of application of Bavi is such that it is theorized that Bavi is training the immune system to recognize the virus, so reintroduced virus can still be suppressed after a Bavi treatment, residual Bavi is depleted. Bavi's training of the immune system to recognize cancer cells has not been discussed, but could also be a factor.
I suspect there are several degrees of freedom in play here as PPHM has designed trials to investigate the array of applications for Bavi, e.g. dose, administration intervals, duration of sustained Bavi residual, single vs. multiple indications, AC vs. AV etc.
Does Bavi need to attach to all the mass of inverted, exposed PS in order to eliminate a tumor, and do "layers" of cancerous tissue need to be removed by the body's immune system to expose additional cancerous cells for effective treatment? Does that take days, weeks or months to go to completion? For Bavi AV, does Bavi need to be present in the bloodstream at timing to interact with residual virus that attempts to redistribute itself in the body, or does the "training" of the immune system take care of the reintroduced virus, even after the body has purged all residual Bavi out?
In these cases, maintenance of a residual of Bavi in the bloodstream for a period of time sufficient to outlast the cycles of removal of cancer cells or the reintroduction of virus, may be needed. Also, the mass of the tumor will need consideration when determining how much Bavi needs to be administered. The Bavi AC trial is also quietly assessing these issues, such that PPHM can cross reference findings to design for the range of Bavi AC and AV applications.
So, with the repeat dose trial, Bavi is being administered twice a week for two weeks, building on the finding that Bavi resides for three or four days after administration.
Is preserving a two week residual of Bavi in the body sufficient to last out the process of virus reintroducing itself from residuals in remote places or is a longer lasting treatment regimine needed? How about for Bavi AC? How about for combo trials?
Is a 0.3 mg/kg repeat dose sufficient to eradicate available virus through attachment to all exposed inverted PS or is a 3 or 6 or ? mg/kg dose needed?
It was suggested on this board that Bavi administered to a virus free patient could retain a residual in the body for longer periods and that whether a fully humanized, chimeric or mouse version is administered makes a difference for how long it takes a body to purge 3G4/Bavi. Would it make sense to consider switching from the fully humanized to the chimeric version or vice versa to optimize treatment?
I presume that PPHM is considering such matters. As long as their intellecutal properties are protected, I see it in PPHM's and long investor's best interest to keep control of Bavi and keep findings closed to within the research community until PPHM is ready to tell a compelling Bavi story to the market.
What can long investors do while we wait? Watch for the identified PPHM business plan milestones identified in PPHM communications to "connect the dots" to where PPHM intends to go directionally. Observe whether milestones are being met or missed and why. Invest accordingly.
It is my understanding that the remaining 2.2 million warrants from the previous placements will expire by the end of the year and will bring PPHM about $2.5 million if exercised. The recent Bavi safe and well tolerated news and UU placement helped establish PPHM operational funding to meet PPHM needs into 2007. The investment dynamics for PPHM are changing to favor long interests at the same timing that results from Bavi and Cotara trials should be coming in to reinforce the value of PPHM's intellectual properties. Any Bavi demonstration of success in trials should be getting reported at good timing.
Best wishes and IMO.
KT
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