Summary of the pipeline

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

Postby rainer » Mon Mar 03, 2008 6:20 pm

a little update on MBP8298.

BioMS Medical's Relapsing-Remitting Multiple Sclerosis Trial Receives Positive Review from Data Safety Monitoring Board

Toronto Stock Exchange Symbol: MS

EDMONTON, March 03, 2008 /PRNewswire-FirstCall/ - BioMS Medical Corp. , a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting MS has completed a safety analysis and recommended that the trial continue as per the protocol.

This was the third of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.
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Postby dignan » Wed Mar 05, 2008 9:49 am

I'm adding TBC-4746 from Encysive Pharmaceuticals to phase 1. Encysive is in the process of being bought-out by Pfizer. The drug is an oral VLA-4 antagonist (same target as tysabri).

http://www.encysive.com/products.html

http://www.encysive.com/clinical.html
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Postby dignan » Thu Mar 06, 2008 9:11 am

I added BGC20-0134 to the list in phase 1, based on this article:

http://www.pharmalive.com/News/index.cf ... egoryid=21
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Postby dignan » Fri Mar 07, 2008 9:10 am

Based on the latest worm article post elsewhere, I moved helminths to phase 1 from pre-clinical.
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Postby rainer » Tue Mar 18, 2008 3:20 pm

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Postby dignan » Tue Mar 18, 2008 7:46 pm

rainer, thanks for the tip. I wish the pharma companies would be a little clearer about their plans. From their press release today, Peptimmune says: "The Company plans to initiate its first repeat dose study in multiple sclerosis patients in Q2/2008." Normally, if you've successfully completed a phase 1 trial, you move to phase 2, but they don't call it phase 2, and I have seen cases where there are multiple phase 1 trials. So I don't know where to put it now...

http://www.peptimmune.com/news_details.asp?NID=22
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Postby Lyon » Wed Mar 19, 2008 6:02 pm

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Last edited by Lyon on Mon Nov 28, 2011 6:25 pm, edited 1 time in total.
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Postby dignan » Mon Mar 24, 2008 6:27 pm

I removed AVE9897 (Sanofi-Aventis) and Osteopontin (Merck Serono) from phase 1 because they have both disappeared from their sponsor's websites.
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Postby dignan » Tue Mar 25, 2008 8:18 am

Based on Bromley's "relative of copaxone" post, I will add FYAK to phase 1.
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Postby rainer » Sat Mar 29, 2008 3:23 am

Maybe one for the pre-clinical list as it mentions a neuroprotective effect that could involve optic neuritis.

Sirtris Pharmaceuticals Scientific Advisor Shows SIRT1 Activation Improves Huntington's Disease In Preclinical Model
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Postby dignan » Sat Mar 29, 2008 8:08 am

I have to admit I've stopped maintaining the pre-clinical part of the list. Things that make it into phase 1 only have about a 10-15% chance of being approved one day. The chances of the pre-clinicals being approved one day is somewhere under 1%, so I just can't be bothered anymore. Sorry.
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Postby dignan » Mon Apr 07, 2008 7:43 am

I moved MN-166 from phase 2 to phase 3 upon their announcement today of successful completion of phase 2. I guess technically they don't have regulatory approval to go ahead with phase 3, but I'll jump the gun as usual.
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Postby rainer » Mon Apr 07, 2008 5:46 pm

A pilot study for a spasticity med, so probably not enough to crack the list but I figure positive results are always welcome.

NovaDel Announces Positive Data from Pilot Pharmacokinetic Study Comparing Tizanidine Oral Spray to Zanaflex(R) Tablets
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Postby dignan » Mon Apr 07, 2008 8:15 pm

Yes, all positive results welcome. Thanks rainer.
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Postby rainer » Mon Apr 28, 2008 4:38 pm

Dignan must be on vacation, so here's some news:

KaloBios Completes Patient Dosing in its U.S. Phase 1 Trial of Its Third Drug Candidate, KB003

KaloBios Pharmaceuticals, Inc., a privately held biopharmaceutical company, today announced that the company has completed dosing subjects in a U.S. Phase 1 clinical trial of its third drug candidate, KB003. The study is a placebo-controlled, single-dose, dose-escalation Phase 1 trial in healthy volunteers, with safety and immunogenicity as primary endpoints.

KB003 is a Humaneered™ monoclonal antibody targeted to GM-CSF, and it shares the same epitope (target) and pharmacokinetic properties with KB002, its chimeric (mouse) precursor. They are part of a major development program that collectively includes five Phase 1 and Phase 2 proof-of-principle clinical trials for inflammation-related diseases, including persistent asthma and rheumatoid arthritis. Animal studies have suggested the drug candidate also has potential in multiple sclerosis, chronic obstructive pulmonary disease (“COPD”), psoriasis, and other indications.

Nuon gets $27M to fund a mid-stage trial

Frazier Healthcare Ventures and Domain Associates have joined forces to lead a $27 million Series B for Nuon Therapeutics, a San Mateo, CA-based developer working on new therapies for autoimmune and chronic inflammatory diseases and pain. Australia's GBS Venture Partners also participated. This is a big step up for Nuon, which raised $5 million for its Series A last year. The new money will go to fund a mid-stage trial of tranilast, an orally active compound. Already marketed in Japan and South Korea for asthma and atopic dermatitis, Nuon is researching how the therapy reduces activated T- and B-cells in animal models of rheumatoid arthritis and multiple sclerosis.
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