Jerry Silver talks to me

[Jawaid]

Good questions Paolo.
I think Jerry himself will be bit disappointed by the decision of acorda not to start trials soon. Should look for some other options now.

[keeping on]

Paolo, I think that Dr Silver has worked with cats also. Still no human work. but not just rats. WE must pester Acorda through a concerted effort. Let them know we want action. Dr silver wants to move this thing along. what do we have to lose. One thing is that Dr silver says he wants to move on this. If nothing happens, then, it looks like Acorda is stalling. Talk is cheap. Action is not.

anthony

[rjames]

Acorda Chondroitinase comment, Read the comment by Dr. Cohen in the last paragraph of the attached article http://www.genengnews.com/gen-news-h...eline/81246646

[keeping on]

rjames I read it. Dr Silver wants to get it on now; we've contacted Acorda and said we are ready; may his dream come true. Let me add; don't stop calling for action. We can e-mail them till th ecarrot becomes a reality.

Anthony

[keeping on]

rjames, let me add; wise Young is currently trialing humans with his therapy. Acorda will be years away from I can see. wise mad e acomment at his last meeting at rutgers. One of the attendees said that wise said; not that far away to begin the USA. All second hand, but that is the closest we have anything at this point. My hope is that Wise, has said safety has been met so far; soon we will hear efficacy. that is the closest we have right now for anything for us in a timeframe that might apply. My dream has been to have a trial we could follow and hopefully participate in in our timeframe of life.

Anthony

[muskie]

I was at Rutgers last open house phase 2 brakenridge (Texas) this year phase 3 next 7 centers in US

[keeping on]

thanks Muskie;phase 2 at Brakenridge this year; phase 3 at 7 centers when?

this is news that the forum has been looking for. Definitve infromation. I forgot to mention Stem Cell INc conducting human trials in Switzerland.

Anthony

[GRAMMY]

So, in keeping Christopher's thread from being hijacked by hourly Swiss/Chinese cell blurbs...

We did notice that Ron Cohen CEO made positive statements to the media about bringing Chondroitinase ABC in the Acorda pipeline to clinical trial. Great News! Thanks for the link rjames! If we can get CSPG under control with Ch'ase we have a fighting chance.

For spinal cord injury, Acorda’s early-stage pipeline includes the enzyme chondroitinase, which Dr. Cohen called his favorite program. “It has, in my view, the best chance to increase plasticity of the injured central nervous system—brain, spinal cord,” Dr. Cohen said. “We’ve shown restoration of walking and bladder function in animal models of spinal cord injury. The science is well understood. My dream is for us to get this into the clinic for spinal cord injury.”

http://www.genengnews.com/gen-news-h...eline/81246646

[muskie]

Originally Posted by keeping on

thanks Muskie;phase 2 at Brakenridge this year; phase 3 at 7 centers when?

this is news that the forum has been looking for. Definitve infromation. I forgot to mention Stem Cell INc conducting human trials in Switzerland.

Anthony

supposedly phase 2 April this year, phase 3 august 2013 give or take a couple of months

[GRAMMY]

http://www.bloomberg.com/news/2012-0...-correct-.html

Drugmakers Upset Approval System Plan Biotechs Sought


Drugmakers have fought off a U.S. senator’s proposal that would have approved medicines for diseases that are fatal, or have no existing treatments, based on fewer human trials.

Biotechnology Industry Organization



The plan, drafted by Democratic Senator Kay Hagan of North Carolina, was supported by biotechnology companies to speed up approvals and make the process less expensive. It would have created a program with the flexibility to allow drugs to be cleared based on any testing that shows they may be effective. This may include early trial results, interim data and use of so-called biomarkers that measure the effects of a molecule on biological functions linked to a disease.

The unusual dispute pitted biotechnology companies struggling to finance extensive trials against larger drugmakers who often trade financial aid in return for sharing sales later, said Erik Gordon, a business professor at the University of Michigan in Ann Arbor.
“Smaller biotech companies often can’t raise enough money on their own to do the currently-required safety trials, so they want to dilute the rules to let them get approvals without having to give big pharma a cut of the action in return,” said Gordon, who is based in Ann Arbor, in an e-mail. “Big pharma says ‘don’t dilute safety measures for new drugs.’ That sounds better than ‘we want to keep our cut of the action.’”
Biotechnology Organization

The rift played out within the Washington-based Biotechnology Industry Organization, a group that includes both smaller companies such as Acorda Therapeutics Inc. (ACOR), with $1 billion market value, and Glaxo, with a value of $71 billion.
The group’s board is organized into different sections, reflecting the size of their companies. Most of the emerging companies’ group backed the proposal while members from larger companies --including GlaxoSmithKline Plc (GSK) and Pfizer Inc. (PFE) -- mostly didn’t support it, said Chief Executive Officer Ron Cohen of Hawthorne, New York-based Acorda.
Glaxo disagreed with the original proposal, said Sarah Alspach, a spokeswoman for the London-based company. “Our preference is to modify existing tools and programs that are familiar to regulators and regulated companies, rather than create new ones,” she said,
Cohen said safety concerns dominated the debate. “It was very clear by creating a new track we were going to engender so much anxiety and suspicion up front that we were going to never get to the meat of the proposal,” he said in a telephone interview.
Expanded Program

As a result, the industry group now supports a new plan to expand an existing accelerated-approval program for cancer and HIV drugs to include other products aimed at fatal diseases or those with few or no cures, said Jim Greenwood, the organization’s president and chief executive officer.
Hagan plans to introduce the new proposal in Congress this year, he said. The revived proposal does allow companies to use so-called surrogate endpoints showing a molecule’s effects on biological activity. They also must later prove clinical outcomes.
Mary Hanley, a Hagan spokeswoman, declined to comment, as did Peter O’Toole, a spokesman for New York-based Pfizer.
John Vernon, an assistant professor of health policy and management at the University of North Carolina, said the original proposal was seen as a no-win proposition for large drugmakers for several reasons.
“I could see how it would be a threat to have a new process, to think about how to redefine efficacy,” he said. “It would have been a game-changer.”
Broader Legislation

The compromise may become part of broader legislation renewing the fee system drugmakers use to fund FDA product reviews, which expires at the end of September, Greenwood said. Timing is sensitive because talks are occurring during an election year, when Congress typically leaves Washington by the end of July.
Karen Riley, a spokeswoman for the FDA, said the agency has several processes to help speed approval of drugs and will work with Congress going forward.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.