Prosavin announcement ...
 

http://www.firstwordpharma.com/node/...#axzz3ZNtMQg2h

Yep after years we have got to this point (still phase 1 and 2 data originating 10 years ago). Still no clear plan to delivery however I am 52 and have given up on delivery within my natural lifetime.

On a more positive note it is still going (albeit moving in geological based time) where the likes of Ceregene, Neurologix, Spheramine, GDNF et al have largely bitten the dust. So congratulations you Oxford Biomedica boys and a big thankyou ..... thanks. Just see if we can move a little faster here.

Neil.

Wow. This looks amazing. Best case scenario, when do you think it could be commercially available? Or is it so far off now that I shouldn't even dare to hope?

How long is a piece of string ...
 

The main hinderance to Prosavin is the lack of a suitable partner to provide Oxford Biomedica with the finance to take it to market.

I am unclear as to the Safety requirements from the various regulatory bodies, Prosavin appears to have safety data going back 9 years, do they need this for all stages of the test data ? If so, how does anything get to market ? There is a new "super Prosavin" in the wings that will need to be tested, lets hope this is on a faster timescale than what has come before.

I have heard about 2-3 years ago a phase III planned for this year but I can see no clear plan.

I will contact Oxford Biomendica and attempt to get the schedule.

Neil.

Although a company will always monitor side effects throughout the 3 phases to drug approval and even phase 4 post approval they will not be required to conduct another safety trial.

Why do you think they can't find a suitable partner? They currently have partnerships with Novartis, Pfizer, Sonofi, Biogen, GlaxoSmithKline and about a half dozen other companies, all with deep pockets. So they obviously have the contacts and relationships. Why should they have problems with Prosavin?

Gary

Good question Gary ...
 

Two main reasons as I see it:

1 - this is gene therapy, and it has taken 25 years to get to where we are now, I.e. A handful of commercial products. Indeed prosavin is now probably the most mature PD "gene therapy" product on the market. Gene therapy is high risk and scarey. So much easier to bring out another patch.

2 - good but not knockout test results. For prosavin to live DBS has to die and whether we like the idea of traumatically invasive brain surgery, it does set the bar for any replacements high. prosavin scored well vs DBS but didn't score the knockout blow at the dosages given. This is hoped for by "super prosavin".

Anyway as they are only 45 miles from me I have asked, in addition to the prosavin schedule, if they want anything from myself or this board and I will let you know as soon as I hear.

Regards,
Neil.

I agree that I think the problem may be in the not so blockbuster initial results. The second generation OXB-102 may draw more interest than first generation ProSavin.

I'm not sure I agree with your first thoughts. The gene/cell therapy pipeline and market are hotter than ever. There are currently over 200 gene/cell therapy clinical trials going on worldwide for multiple illnesses. The money is flowing freely. Just look at some of the recent M &A and partnership deals which have been announced.
- Pfizer gives up to $2.8 billion upfront to Cellectis for rights to their CAR-T immunotherapies platform.
- Regeneron gives Avalanche up to $640 million for rights to their ocular gene therapy products.
- GSK gives Adaptimmune $350 million for rights to their gene/t-cell oncology treatments.
- Biogen gives Sangamo up to $300 million for rights to their sickle cell and beta-thalassemia (blood diseases) gene therapy platforms, and they are only at proof of concept stage.
- Even Oxford BioMedica has partnered last year with Novartis, with a $90 million royalty for one of their other gene therapy platforms.

My point is that there are plenty of partners, with huge amounts of $, available for gene therapy companies if they are comfortable with the platform and the early results. I think if the larger pharmies and biotechs believe OXB/ProSavin has potential, there will be no issue finding a partner. If they don't, then the product will disappear like many others in the past.

Gary

Good response Gary ...
 

having done some digging it appears there might be no gene therapy products licenced for general use by the FDA. If true then this is really dissappointing.

I was unaware of the "noise" in the gene therapy space and it does raise the issue as to why Oxford Bio have not found a partner. Perhaps it is for the same reason that Neurologix gene therapy platform dissappeared without trace, i.e. the market is just not receptive to gene therapy for PD, (too complex a disorder on too immature an approach). Or perhaps its just that OXB are hopeless salesmen.

Neil.