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I would find it interesting to see how many of the new trials are being sponsored by and combined with other CRABS.
The latest one just posted (green tea) is being combined with Copaxone (and paid for, I assume, by Teva) as is the estriol trial being conducted at UCLA.
Some of these trials are starting to smell to me because if the products work, it looks like Copaxone and other CRAB companies will also be part of the treatment option, whether necessary or not.
Somebody tipped me off that one of the pre-clinical substances has moved all the way to phase 2. It's Sanofi-Aventis' HP184, now called nerispirdine. It's a K+ / Na+ channel blocker.
As I posted in a separate thread today, Bayer announced that the trial of the 500 mcg dose of betaseron failed to achieve it's primary endpoint. I removed it from the list.
Joined: May 04, 2006 Posts: 3405 Location: Mid-Michigan
Posted: Thu Nov 01, 2007 2:12 pm Post subject:
Hi dignan,
I should have mentioned this to you months ago, but I felt things were fine as they are.
John Fleming mentioned that it might be more accurate to consider his upcoming TSO/MS (swine whipworm) study as pre-clinical as opposed to phase II.
As far as progress on the study....on August 20 he hoped to get his final FDA paperwork in a month or so.....1,000+ pages. Come to think of it, that's the same email in which he said it should be considered pre-clinical.
Bob
Quote:
Phase II Trials
18. Helminth-induced immunomodulation therapy (HINT) (U of Wisconsin)
_________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
Joined: May 04, 2006 Posts: 3405 Location: Mid-Michigan
Posted: Thu Nov 01, 2007 3:08 pm Post subject:
Thanks for doing it dignan. Originally it didn't seem worth putting you to the trouble.
Next time I hear from him I'll ask for another update and I'll let you know.
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
Ofatumumab is already on the list in phase 2. Here are details of the upcoming phase 2 trial. With all the discussion around rituxan lately, this one is promising because it goes after the same target as rituxan, CD20, and therefore, B cells.
Genmab Announces Details of Planned Ofatumumab Phase II Study in Multiple Sclerosis
COPENHAGEN, Denmark, Dec. 13, 2007 – Genmab A/S (OMX: GEN) announced today details of a planned Phase II study of ofatumumab (HuMax-CD20) for the treatment of relapsing remitting multiple sclerosis (RRMS). Approximately 324 patients will be enrolled in the study which will be conducted under Genmab’s collaboration with GlaxoSmithKline (GSK). The study is expected to begin in the first quarter of 2008.
Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 receptor. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
“Multiple sclerosis is a debilitating disease for which there are currently few treatments,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We hope our fully human antibody, ofatumumab, may offer another potential treatment option for patients suffering from this incapacitating disease.”
About the trial
The double blind randomized trial will consist of two parts. Part A will include approximately 36 patients in one of three increasing dose cohorts (100 mg, 300 mg or 700 mg of ofatumumab) randomized to receive ofatumumab or placebo. An independent data monitoring committee (IDMC) will evaluate the safety of each sequential cohort prior to progression to the next cohort. When all patients in Part A have had their week 4 MRI scan, the IDMC will evaluate the data before Part B of the study begins.
Part B will consist of a 48 week treatment period of approximately 288 patients. Patients will be randomized to treatment with 100 mg, 300 mg, or 700 mg of ofatumumab or placebo. After week 24, patients on an active dose will receive re-treatment with the same dose of ofatumumab or placebo. Patients on placebo will receive ofatumumab at the highest tolerated dose from Part A.
The objective of the study is to determine the safety and tolerability of three doses of ofatumumab and the dose response of ofatumumab on disease activity on MRI in patients with RRMS. The primary endpoints are safety and cumulative number of new Gd-enhanced lesions from week 8 to week 24.
The pipeline giveth and the pipeline taketh away. Bromely discovered a Merck Serono drug in phase 2 that wasn't on the list, Atacicept. Also, the company's drug Osteopontin is in phase 1 now. On the downside, the former Serono drugs in phase 1, MMP-12 inhibitor and JNK inhibitor are no longer listed on the Merck Serono pipeline. I will remove those 2 from the list. It's a good news / bad news day.
I removed Medarex’s MDX1100 from phase 1 because they are going forward with an ulcerative colitis trial, but the company’s website contains no mention of MDX1100 for MS that I could see.
I'm removing NNZ-2566 from the pipeline (phase 1) as Neuren makes no mention of MS on their site, and also say:
Quote:
Neuren’s strategy is to undertake clinical trials for acute conditions, which are generally shorter and less expensive than those for chronic conditions. This strategy provides the most cost-effective means of increasing shareholder value while controlling risk.
Neuren decides which targets to pursue and which compounds to develop only after consideration of the cost and complexity of trials, the ease with which results can be validated, and assessment of market need and commercial opportunity.
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