Pharma

SPMSS Drug Gets FDA Fast-Track

art — Thu, 04 Sep 2008 09:57:31 -0400

Fast-track designation could help development and speed the review process of dirucotide, for the treatment of secondary progressive MS, now being evaluated in a U.S. Phase 3 trial.

BioMS says about 510 patients have been recruited for the company's U.S. trial at 68 sites and will receive either dirucotide (MBP8298) or a placebo intravenously every six months for two years.

Longer acting Interferon

art — Fri, 22 Aug 2008 15:29:44 -0400

This article about a grant mentions Modigene's interferon-beta-CTP (IFN-Beta-CTP / MOD-901) program, its longer-acting version of interferon beta. Not much info on the drug, but first I've heard of it, so I'm logging it here.

ATL1102 now ATL/TV1102

art — Fri, 22 Aug 2008 15:17:21 -0400

ATL1102 is a drug, similar to Tysabri, developed by Antisense Therapeutics.

On 30 June 2008 Teva and Antisense Therapeutics announced the results of the Phase IIa MS trial and reported that ATL/TV1102 (ne ATL1102) significantly reduced disease activity in patients with RRMS and that the Phase IIa study met its primary endpoint showing a significant reduction by 54.4% in cumulative number of new active lesions in patients taking ATL/TV1102 for 8 weeks, compared to placebo, as measured by magnetic resonance images (MRI). ATL/TV1102 demonstrated an increasing effect with time on the reduction of new active lesions over 12 weeks - one month after the completion of dosing.

Extended release form of Baclofen

art — Fri, 22 Aug 2008 15:11:44 -0400

IPX056 has met its clinical endpoints in Impax Laboratories’ Phase III study of spasticity in multiple sclerosis patients.

The drug is an extended-release formulation of baclofen, a common treatment for spasticity, which has the potential to offer improved control of symptoms and dosing convenience, according to Impax.

Dirucotide (MBP8298) trial recommended to continue

art — Fri, 22 Aug 2008 14:57:28 -0400

There's no real new data here, but it is good to know that dirucotide has passed the data safety monitoring board review for its MAESTRO-01 trial. This drug is being tested on people with SPMS, which is unique.

Peptimmune Status Update

art — Tue, 05 Aug 2008 16:01:35 -0400

PI-2301 is a second-generation peptide copolymer from a similar compound class as Copaxone. PI-2301 has been designed to be more efficacious and more convenient (weekly versus daily dosing) than Copaxone for the treatment of multiple sclerosis. This press release about their new patent provides a nice opportunity to update us on the drug's progress.

Two new cases of PML in Tysabri

art — Fri, 01 Aug 2008 09:08:03 -0400

And it all seemed to be going so well. Biogen Idec just reported two confirmed cases of a deadly brain infection progressive multifocal leukoencephalopathy (PML) in patients taking the multiple sclerosis drug Tysabri. Both are in Europe and one patient is stable and at home, the other is still hospitalized.

They won't be pulling the drug, as this is a known complication, but it will certainly cause many to reconsider staying on it or getting on it. No details given around the circumstances particular to these individuals, but I'm sure they'll be forthcoming when they have them sorted out.

Astra-Zeneca working on an MS diagnostic

art — Wed, 23 Jul 2008 15:02:51 -0400

Here's a patent claiming to be a diagnostic for MS based on the level of phosphorylation of particular proteins whose measurement values in a biological sample are different (either higher or lower) in a subject with MS as compared to a standard level or reference range established by obtaining measurement values for the biomarker in subjects who do not have the disease (“normal controls”).

This is interesting because: I hadn't heard of this work before and patents generally lag the work by a few years; and it is looking at epigenetics as a biomarker which hasn't been done a lot.

Teva's latest ups and downs

art — Wed, 23 Jul 2008 12:28:14 -0400

Check it out:

Laquinamod trial with Active Biotech is moving along
Under investigation by Israeli health ministry
Generic Copaxone coming
Teva CEO says 'No it is not'

Tysabri Turns Two

art — Tue, 22 Jul 2008 11:48:48 -0400

Tysabri has been back on the market for 2 years now. A whopping 17,800 people are taking it in the US, with 13,400 more world-wide. No new cases of confirmed PML have been seen, but only 6,600 people have been on Tysabri for more than 18 months.

So far, so good!