Phase 3 trial end-dates

dignan · Post by **dignan** » Sun Nov 23, 2008 4:40 pm

Since we're getting close to the end of some of the phase 3 trials, I thought I'd post a summary of what we know about those trial completion dates. The list below includes only those drugs that have completed enrollment in at least 1 phase 3 trial (e.g. no MN166 on this list).

In order of trial completion:

1. cladribine (Mylinax) (RRMS)
- announced completion of enrollment of first phase 3 trial: January 16, 2007
- study completion: January 16, 2009
- submitted to US and European regulators 3Q2009, submission incomplete
- resubmitted June 2010

2. Fingolimod (FTY720) (RRMS)
- completion of enrollment of first phase 3 trial: summer 2007 (not sure exact date)
- study completion: summer 2009
- submitted to US and European regulators December 2009
- FDA committee recommends approval June 2010

3. Teriflunomide (RRMS)
- completion of enrollment of first phase 3 trial: October 2008
- study completion: October 2010

4. Laquinimod (RRMS)
- announced completion of enrollment of first phase 3 trial: November 18, 2008 and completion of enrollment of second phase 3 trial in June 2009
- study completion: November 18, 2010 / June 2011

5. Campath (alemtuzumab) (RRMS)
- announced completion of enrollment of second phase 3 trial: September 11, 2009
- study completion: September 11, 2011

6. BG00012
- 2 phase 3 trials have completed enrollment, one in January 2009, the other in September 2009
- study completion: January / September 2011

7. Cannabinoids (CUPID trial) (progressive MS)
- announced completion of enrollment of trial: July 21, 2008
- study completion: February 21, 2012 (some patients will be in trial for 3.5 years)

daverestonvirginia · Post by **daverestonvirginia** » Mon Nov 24, 2008 1:18 pm

Thanks so much for the information. Really feels like some progress is being made. I know we all want things to go faster, but today's reality is so much better than even five years ago.

patientx · Post by **patientx** » Mon Nov 24, 2008 5:03 pm

For what it's worth, nurse coordinator at the MS center near me told me that, if Cladribine is successful in its phase III trial, the FDA has agreed to fasttrack its approval.

rainer · Post by **rainer** » Mon Nov 24, 2008 8:01 pm

good info, thanks!

thinkingoutloud86 · Post by **thinkingoutloud86** » Mon Nov 24, 2008 8:46 pm

Thanks for posting this info.

dignan · Post by **dignan** » Mon Nov 24, 2008 8:51 pm

Thanks for the info Patientx. I think that means that Mylinax could possibly be approved by the middle of 2009. Is fast-track 90 days? 120 days? Something like that.

patientx · Post by **patientx** » Tue Nov 25, 2008 7:00 am

Dignan:

That's a good question. I will ask when exactly Cladribine might be approved the next time I talk to the nurse (I'm in the CombiRX trial there, so I have to keep in touch with them).

Dr Rus' presentation at this link

http://www.umm.edu/ms/symposium_presentations.htm

has some info on Cladribine. His concluding slide shows it being approved a few years from now, but the slides might be a little dated. The other 2 presentations are pretty good, too.

patientx · Post by **patientx** » Tue Nov 25, 2008 7:48 am

Ok, I was curious, so I did a little web searching. This link has a little information about what "FDA fasttrack" means:

<shortened url>

I will still ask about the status of Cladribine when I get the chance.

Mike

dignan · Post by **dignan** » Sat Jan 17, 2009 9:30 am

I think the first phase 3 Mylinax trial ended yesterday. No press release about it though. I suppose the company might not talk about it until they at least have some top-line results to report, so we might have to wait a few weeks.

And now back to the usual, hurry up and wait.

patientx · Post by **patientx** » Sat Jan 17, 2009 10:00 am

I think it will be interesting, when the FDA hearings for some of these oral drugs start, what representatives from the drug companies producing the injectables will have to say. Will they have negative comments in an effort to protect their sales?

dignan · Post by **dignan** » Sat Jan 17, 2009 11:04 am

Will they have negative comments in an effort to protect their sales?

Can a leopard change its spots? I think there is absolutely no doubt that the CRAB-makers will unleash the strongest FUD campaign they can muster.

dignan · Post by **dignan** » Thu Jan 22, 2009 12:22 pm

I think the first phase 3 dirucotide (MBP8298) trial for SPMS ends today. No press release about it yet.

Lars · Post by **Lars** » Fri Jan 23, 2009 4:45 pm

Dig,
I wish I got as much pertinent info from my battery of Neuro's as I get from you. Thank you soooo much for all you effort. I hope you realize how much your efforts are appreciated.
Lars

patientx · Post by **patientx** » Fri Jan 23, 2009 5:09 pm

I'll second that.

mrhodes40 · Post by **mrhodes40** » Fri Jan 23, 2009 5:48 pm

ANd me too. Thanks Dignan!