Dirucotide-ph. 3 for SPMS

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Postby dignan » Mon Jul 27, 2009 9:20 pm

Oh crap. Thanks for the link Cheer. I didn't expect this one to be incredibly effective, but I was hoping it would at least offer some benefit in SPMS.
User avatar
dignan
Family Elder
 
Posts: 1610
Joined: Wed Aug 11, 2004 3:00 pm

Advertisement

Postby fernando » Tue Jul 28, 2009 2:10 pm

It didn't meet its secondary endpoints also.

At least it has no secondary effects :lol:

But, really, very sad indeed.

Viewing the scale of these failures one has to wonder about the whole process of developing drugs. I mean, dirucotide had at least 10 years of developing and nobody saw this massive failure coming?
User avatar
fernando
Family Elder
 
Posts: 228
Joined: Wed Jul 15, 2009 3:00 pm
Location: Argentina

Postby Frank » Tue Jul 28, 2009 4:43 pm

Another report about the fail of phase-III. It says all ongoing studies with dirucotide will be discontinued :(.
http://www.reuters.com/article/marketsN ... 728?rpc=44

--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
Frank
Family Elder
 
Posts: 542
Joined: Wed Jan 03, 2007 4:00 pm
Location: Germany

Postby scorpion » Tue Jul 28, 2009 5:40 pm

1 year ago in a galaxy far far away:



BioMS/Lilly's dirucotide shows promise in Phase II/III MS study
PARIS, Aug 14,2008 (APM) -

The Canadian biotech BioMS Medical announced on Wednesday early positive findings of a Phase II/III study of dirucotide (MBP8298) in patients with secondary progressive multiple sclerosis (MS).
User avatar
scorpion
Family Elder
 
Posts: 1323
Joined: Wed Nov 05, 2008 4:00 pm

The analysis of the phase III by a neuro and investor

Postby fernando » Fri Aug 07, 2009 12:48 pm

http://neuropipeline.com/?p=98

I expounded more on the reasons that I felt the Phase III would fail at seekingalpha (see link above). Most importantly, the decision to proceed to expensive Phase III testing (1100 patients in 2 studies) was done prematurely based entirely on a very small study of 32 patients, further split into 20 patients with HLA-DR2 or DR4. These 20 patients were further split into 14 SPMS and 6 PPMS patients, a ridiculously small number of patients to try to analyze. No attempt was made to determine if every 6 month dosing was best by doing a larger and more controlled phase II looking at other doses. Maybe the medicine would have worked with monthly dosing. Second, the mechanism of action — tolerance induction — is unlikely as the MINDSET RRMS study failed to show an effect on inflammation, much more suscetible to tolerance induction than the degeneration of SPMS. I may have felt different about the prospects if a plausible MOA was advanced and supported by evidence. An additional reason I may not have mentioned is that 2 years may have been too short for the study.

As long as I’m rambling, I’ll add my two cents about small companies in Biotech and the decisions to proceed to phase III. BioMS could not have proceeded as far as they did without either a partnership, private equity or a second public offering. They rightly calculated that a product just starting Phase III would have more value than one that just has a 20 patient phase II. Initiating the MAESTRO studies allowed them to gain a reasonably good deal with Lilly, a company that could easily spare 97 million (87 + 10 milestone at 200 patient review) to have a shot at a 1 - 2 billion dollar a year drug. Thus, BioMS had nothing to lose by rushing the drug along. A larger company would have done a larger phase II forst and then decide whether to advance the drug to expensive phase III studies or just let the agent die. BioMS, with one drug, could not afford to let the drug die in Phase II. I’m going to keep this in mind when I look at other small companies that may have rushed a product along.
User avatar
fernando
Family Elder
 
Posts: 228
Joined: Wed Jul 15, 2009 3:00 pm
Location: Argentina

Postby dignan » Fri Aug 07, 2009 3:13 pm

Thanks for that Fernando, that sounds like exactly what's going on right now with daclizumab moving to phase 3 while a large phase 2b trial is still recruiting.
User avatar
dignan
Family Elder
 
Posts: 1610
Joined: Wed Aug 11, 2004 3:00 pm

Previous

Return to Drug Pipeline

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users