This is so exciting!! My contribution will be very small, but it will be in the mail!! Carolyn

Dear Friend,

The Michael J. Fox Foundation needs your help. We have an opportunity to raise $1 million for research on CERE-120, an innovative new treatment for Parkinson’s disease with potential to do what no currently available treatment can: slow or stop the progression of the disease. The research will investigate gene therapy delivery of neurturin, a trophic factor that spurs the production of dopamine in the brain.

Daniel Spitzer, MD, a member of MJFF’s Board of Directors, and his family are so excited about Ceregene’s Phase 2 trial of the treatment that they have agreed to contribute as much as $500,000 to support the trial. However, their generous gift has been conditioned on MJFF raising an additional $500,000 as a match.

Click here to make a tax-deductible donation that will immediately be doubled in size by the Spitzer Family Challenge.

Ceregene, a San Diego-based biotechnology company, completed its CERE-120 Phase 1 safety trial (partially supported by a Foundation grant) in 2007. Not only did CERE-120 prove safe, it showed potential to slow or even stop the progression of Parkinson’s disease.

The next step was to move forward with a Phase 2 trial in a larger patient population to determine the effectiveness of the treatment. The multi-center trial of CERE-120, sponsored by Ceregene and partly supported by MJFF, is considered by many Parkinson’s researchers to be the field’s most exciting development in years — and potentially closer to patient impact than any other novel PD treatment currently in development. (Click here to read more.)

Together we can meet this new and exciting challenge. Thanks to this wonderful opportunity being provided by the Spitzer family, your tax-deductible gift of $50 immediately becomes $100 to support this important clinical trial. A gift of $500 immediately becomes $1,000.

Please click here to donate to the Spitzer Family Challenge right now.

If you have any questions, you can reach me directly at lfleisch@michaeljfox.org.

Sincerely,
Leslie Fleisch
Associate Director, Annual Giving

I wish they accepted PayPal!

Time to organize business angles?.....should be interesting and hopefully successful. Once again, if the patient isn't in the formula, good luck.

It's up to us - we can't afford to wait for our doctors to go first. Carolyn, asking your opinion here and hope I don't put you on the hot spot' Some data to go with that release would truly show good faith; what do you think? or did I miss it?

paula

Paula, if you are asking about Phase II results, that won't be available until late this year. The trial will complete about September (12 months after the last surgery,) then the data will go to the analyst.

So it is just a waiting game, but MJFF is excited...or so it seems.

All I can do it be hopeful, for myself and everyone else, especially those yet to be diagnosed.

I meant wouldn't it have been helpful for the team to give us some information to go on. In the light of so many treatment halts and med unapprovals, i'm not sure i would send money to this without more specifics.

i wasn't in any way trying to say you shouldn't be hopeful about the results; we all have hopes for this treatment. I would probably help fund it; but want to know more specifics.

hope that was clearer,
paula

I have never understood why results of a trial have to be secret until the great unveiling at the end.

Still this excitement is catching, GO CERE.

Neil.

Neil, in a double blind, randomized trial like CERE-120/Neuturin NO ONE but the surgical team is privy to what the patient did or did not receive during surgery. And post-surgery the participant does not see the surgical team again, except for a single surgical follow up for sutures and such, unless there is an adverse event such as mine immediately after the surgery and before the initial hospitalization release.

So, until the data is collected from all sites and analyzed there is no news or results to give. Our PD progression post-surgery is determined by a "blinded rater," someone who knows nothing about how our PD was pre-surgery, and who has no verbal contact with the trial site staff about the trial and knows nothing of what to possibly expect from the surgery.

Does this make any sense?

As participants it would not be fair for us to say we are better or not better before the un-blinding occurs and we find out ourselves what we did or did not receive. I may find out that I was doing great since the surgery, only to discover that I got shammed and that it was all a placebo effect. As a communtiy, we PWPs are very susceptible to placebo effect.

So, bottom line, it is not a secret, only unknowns at this point in time. Hopefully, the data collection and analysis will begin in September/October of this year and we will all have news about Phase II before they end of this year!

They should be able to report Phase i, within the press release, in layman's terms. Doesn't have to be complete. ]

Here's what I am getting at Carolyn. We are challenging the placebo effect to a certain extent. I think it's a great idea to raise money this way; but it's not good enough to ask because it's promising and will be doubled.

This is a discussion with the intent to cause even more of the kinds of changes we have been asking for.

can't take it personally , altho i don't know how you are supposed to disassociate it......just know that my intent is..if they want people to give money, they need to show the givers the beef.

paula

adding:
still thinking as usual.....I'd be willing to raise a thousand dollars, which would become 2,000, if we can be briefed about all things that can be made public and provided with an explanation for requests denied. Reasonable - not defensive - in the spirit of can we do this? If patients can't handle hearing about adverse events, then perhaps a trial to this extent isn't right for them. let's get REAL.

who appear to be one of the most progressive companys in our field, if only other companies shared their urgency.

The prime example of the never ending trial is my old favourite Spheramine which has had a staggering four year phase ii trial (April 2003 to June 2007), and we won't hear anything until September 2008, five years from "soup to nuts" before any news creeps out, (and at least the same to come for phase iii).

By now the first batch of Spheramine phase ii participants are five years down the track, why not set reporting dates for batches of patients at pre set times instead of only reporting all at the same time. If Spheramine didn't work surely we would have known this in 2005 !!

If it didn't work then the patients who had surgery in 2006/2007 were put through potentially life threatening, (possibly sham), surgery for nothing. If it did appear to work in 2005, by releasing this news more people will participate in the trial meaning quicker results, faster time to market.

I may be working with Tom Isaacs over the next few weeks on a presentation to the UK Royal Medical Society and if so, then turnaround time and organisation of clinical trials and time to market would be my number one message.

Hope this explains and good luck to Ceregene.

Neil.

Neil,

i didn't think you were getting on ceregene. It's because they are so progressive that I think they would only be more trusted by sharing anythng they can without violating any regs.....this is what we have been asking and I understand the need for blinding, but something needs to be worked out to define this sharing. Give it a name, it can be very anecdotal.

Here's hoping that I am understood - i think the time is now to speak up about a few things that could improve the situation all around. And If you are working with Tom Isaacs - I know you are going to do that too. Keep us posted please!

paula