On the MJFF website is a publication titled: The Brin Wojcicki Challenge: Making Parkinson's Disease History.
On the PDF page 22 (presentation page 20), there is a summary list titled: Early MJFF Investment Leads to Follow-on Funding. This is the point where PBT434 has received an initial investment almost 2 years ago. Follow-on funding examples in this presentation among the 8 listed range from a low of 2 items at $300,000, but the rest range from a low of 1.5 Million to a high of $3.1 Million related to advancement of drugs from pre-clinical stage to Phase II.
So while my wildest hopes are for a Sanofi like partnering deal with MJFF, the more realistic and grounded in reality expectation would be to hope for follow-on funding along the lines of a 1.5 to 3.1 Million follow-on grant.
So I used this presentation as my basis of establishing hopes that are based on this reality check. Of course, It is always an honor to receive something like this, verses something that is owed to Prana. I felt the pre-clinical results and the animal study data was impressive enough that they would want to further PBT434 as a candidate with potential for disease-modifying results, and PBT434 would not be alone in that pursuit if you happen to go read the presentation.
There is also a page dedicated to repositioning existing drugs, such as the elanercept (Enbrel) mentioned this morning on another thread - which is marketed by Amgen & Pfizer could possibly be a candidate for repositioning for TBI and even AD in that example.
The possibility of more funding from MJFF is indeed intriguing. If Prana were able to get a couple of million bucks from MJFF, this money could be used for a Phase I study of PBT 434. Prana has indicated that PBT 434 will be ready for Phase I sometime next year.
Reviewing this release highlights the milestone based nature of the MJFF pipeline program: MELBOURNE, AUSTRALIA--(Marketwire -08/29/12)- Prana Biotechnology Limited (PRAN) (PBT.AX) announced today that its lead compound in development for Parkinson's disease (PD), PBT434, had progressed successfully though a series of preclinical development studies used to assess the suitability of a candidate compound for human clinical studies. The studies were funded by The Michael J. Fox Foundation (MJFF) 2011 Pipeline Program to support its 'Therapeutic Development Initiative.' The MJFF Program grant is milestone based. PBT434 achieved all of its milestones in preclinical toxicology studies, genotoxicity and safety pharmacology -- allowing the compound to be positioned for larger scale animal toxicology studies prior to commencing clinical trials.
PBT434 is a novel, orally available compound that easily crosses into the brain and is able to exert potent neuroprotective properties. Most particularly, it preserves the brain tissue in PD that degenerates over time, the substantia nigra. By preserving this tissue, Prana's scientists have demonstrated significant restoration of motor coordination and strength in animal models. PBT434 has been shown that it is able to impede the iron-induced oxidative damage and neurotoxic cascade that kills the substantia nigra. As such, PBT434's mechanism of action offers a novel disease modifying therapeutic strategy in contrast to the currently marketed symptomatic agents that, at best, serve to reduce the side effects of the disease rather than alter its course.
"Based on these efficacy studies and now the completion of this suite of preclinical development assessments, Prana will look to move PBT434 into longer term toxicology studies in parallel to our scale up manufacturing plans for PBT434. All being well, we could file an IND by the end of next year and commence clinical trials in 2014," said Mr. Geoffrey Kempler, Prana's Executive C
I took one example from the list that received follow-on funding and in that example the follow-on grant occurred even before the anniversary date - by as much as six months or so.
Ceregene has been working with MJFF since 2005 and has received five grants occurring at various times.
I think there is not a hard and fast deadline really. I have been hoping to see this announcement anytime since Prana announced publicly that they met all their milestones in the MJFF 2011 Pipeline program, and since then they have released additional animal study data that indicates it is worthy of pursuit.
Certainly I can make no guarantee that any follow-on grant will occur in August or at all, but it does happen to be the two year anniversary, and it is possible it was considered a two year grant - which I have also seen with MJFF with other companies. I am still quite optimistic it will progress to follow-on funding or advance with MJFF through some partnership approach.
So my hope for August is a continuation of my "anytime now" hope over the past months, plus the fact it would also now be past the 2 year anniversary of the initial grant come Aug 22nd - that's all.