Spheramine(R): did not meet Phase IIb study's primary or key sec endpoints
 

Titan Pharmaceuticals Announces Spheramine(R) Initial Phase IIb Results
07.02.08, 7:01 AM ET


Titan Pharmaceuticals, Inc. (AMEX:TTP) today announced initial analyses show that Spheramine(R) did not meet the Phase IIb clinical study's primary or key secondary endpoints, with no significant differences detected between the Spheramine and sham surgery arms of the study after 12 months of follow-up.

read the full article:
http://www.forbes.com/businesswire/f...2005205r1.html

What a shock and a pity that ...
 

it took so long to find this out. My thoughts go to the bravery of people like Peggy, BobT and jllanguille's mother, the latter suffering tragic consequences from this trial. So much time and human spirit invested for nothing.

GDNF, Spheramine, looks like we are staring at gene therapy as our next great hope, after that ..... who knows.

Perhaps PD is incurable with our current knowledge and technology, personally having been dx'ed at 40 and 5 years in I have a lot of PD to go and only so much more usable time. Better get on with it I guess.

Neil.

Thanks for posting, Jean.
 

Neil (aftermath)

I am extremely disappointed in these results, especially having been in the first six to undergo this procedure. But I have said this many times in the past - there are no failed trials. I have several thoughts concerning information gained from this trial, but want to do a little research before responding.

By the way, over 3,000 people had viewed this message as of 10:00 am EST today!

Peg

this is outrageous
 

Spheramine DOES work.

This is why there should be patients in the process - what were the end points that they failed to meet?

We have pwp who are doing better - just not good enough to meet the end points? maybe researchers need to reevaluate what a SUCCESS is. I bet that success measured by a pwp is VERY different than success to measured by a researcher.

GDNF failed but it works
spheramine failed but it works

the system is broken

AT&T will be putting on more staff
 

It''s very hard to believe, it would have been nice to have permitted the doctors who we have trusted with more than our time to be given the chance to discuss this with their patients. I too will be making calls, not to scream but to hopefully be able to understand the results. Peg I know this is very disappointing for you. Hey at least you know what you have. Many of us I imagine will find out shortly. For me the discouraging part is There are 77 people now eliminated from future selection at clinical trials, regardless of sham or not.

Bob T. said: There are 77 people now eliminated from future selection at clinical trials, regardless of sham or not.

That's not true - some will allow acceptance, but definitely no surgical trials. I've been in three other trials since my operation.

Titan isn't finished reviewing the data - and Spheramine helped me and several others, just not enough to satisfy what was set as endoints.
I have an idea that some of the technology or procedures will continue.

It behooves me, however, that on June 24 at the 12th International Congress of Parkinson's Disease and Movement Disorders in Chicago, they were singing its praises. (see http://www.drugs.com/clinical_trials...on-s-4917.html ) This says the unilaterally-treated participants (like me that only had the cells on one side of my brain) showed good results.

So in June they were reporting good stuff, and the next day we get the bad news. (you might find this blog interesting written BEFORE the negative results were reported) http://invivoblog.blogspot.com/2008/...l-therapy.html

I was prepared for this - I've seen it happen many times. What REALLY irritates me is that before the news release ink was dry, Bayer (big pharma company) pulled out. At least Titan (small biotech company) is not saying it's over yet - because it ain't over until the fat lady sings (and I'm not singing!) lol I despise headlines like this from www.fifercebiotech.com "Bayer dumps Titan drug on mid-stage failure." The word "drops" would have just as easily fit in that space using "dumps." Where is "personal" element here???

Let's keep out chins up. Maybe next time they try the experiment, we'll "bathe" our brains in GDNF - that should do the trick!
Peg

it's almost not worth it
 

I think it behooves everyone to study this data with a fine tooth comb. To keep from rambling, I'm going to list my questions and concerns - not to be taken as facts.

I wonder if:

Spheramine is not enough of a magic bullet - that's what they are looking for. It's too subtle.

I wonder if the technology used, as well as the substance, is already outdated. Isn't anything developed that long ago suspect for being replaceable with something that would make more money by now? This is what we kept saying about GDNF - stop and treat - don't keep waiting for the silver bullet.

How much of the results depend on the individual surgeon and staff at the various centers?

How many of the patients with no uncertainty have PD? Then there are subtypes. Was this data run with updated information on subtypes? Can it be? What about other conditions? [ I am sorta surprised that diabetics were allowed to participate in the ceregene trial, but don't begrudge the fact. ]

Has there been a consistent champion for Spheramine?

Are there patients out there who are really upset over this? Peg is not happy by any means, but was educated enough to expect it. She feels that it definitely helped and still is making a difference, but she has only received it on one side and feels that the effects are waning after 8 years and was hoping to get the other side done to buy her more years. Peg correct me if I am misspeaking about this. Are there people out there who will be surprised if they have been shammed? Is there a reason for them to be upset that they may not ever get the real thing?
Are people saying that it changed their lives?

If so, there lies our perpetual problem. They are looking for a silver bullet because otherwise it will be replaced. What they start is already replaceable by the time it gets to phase II. Treatments don't make it out of phase II.

Which brings us to the next one - gene therapy and ceregene. Already in phase II - which shows us how much progress has been accomplished in streamlining the drug development process . But even a ceregene investigator [ a very prominent pd researcher] told me face to face he'd rather be using GDNF instead of neurturin.

Right process, wrong drug. Right drug, wrong delivery. Right delivery, right drug not shared. And if you aren't blinded, your miraculous recovery is all in your head. Spheramine participants - I feel for you..and hope you discover the truth.

Bayer -profit over people of course. They flew the coop before the ink was dry.

paula

Demand Change
 

"Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it's the only thing that ever has." Margaret Mead
A well chosen quote. The system IS broken but how can we fix it? In the wake of the GDNF fiasco and now this, perhaps its time that we write our congressmen and demand a congressional inquiry. The question I'd like to ask is this: how do they justify their encouraging press releases one day then follow up the next day pronouncing the product a failure. One can't help it but it makes you wonder who cleaned up in the stock market?
Don't you think the pharmaceutical industry has an obligation to humanity a obligation only the federal Government can enforce. little rock

Bayer suspected this was going to happen ...
 

for years, with Titan's lousy share price Bayer could have bought them many times over to secure all the return from Spheramine but they didn't. Why not, if Spheramine had succeeded then the price would have been far higher.

Also why did the MD and founder of Titan quit in April.

Also why were positive press reports being issued (as documented in Paula's e mail) until the bitter end.

“Ever get the feeling you’ve been cheated?” were Johnny Rotten’s last words from the stage as a Sex Pistol (sad old punks like me will remember that). Applies equally well here. Big pharma really screwed us on this one.

Neil.

I stand corrected
 

Thanks Peg. I was remembering interview questions and relating them here (Bad Bad bobT)
Titan did say they will review the data, but with no cash cow and another drug gettig close George Bailey wont need to fear them putting all their resource there Aw Its A Wonderful Life Bt I agree they learned alot along the way and we must be one step closer Happy 4th