Summary of the pipeline

[dignan]

rainer, thanks for posting that info. The second one, tranilast, is in the pipeline in phase 2 under kynurenine, but it's always good to hear updates. The first one from KaloBios doesn't actually say that it is in trials for MS. MS seems to be one of the diseases they are considering trying it out on. I'll wait for them to actually start an MS trial.

[rainer]

an article on a small prozac study, not sure of it's relation to the phase 2 study on the list. (sounds like a phase 2 though).

Prozac may slow MS - Dutch study

The popular antidepressant Prozac may help slow multiple sclerosis, according to a Dutch study showing that people who took the drug had fewer of the brain lesions that are a hallmark of the incurable disease.

[Lyon]

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[dignan]

Hey rainer, nice find. Yep, it's the same Dutch group that prompted fluoxetine's addition to the list. It was based on this: http://www.controlled-trials.com/ISRCTN38456328

That info says the trial was to go for 2 years, not the 6 months quoted in the article you found...and it's not supposed to end for another year. I don't know if a. this is a different study by the same group, b. interim results of the longer study, or c. they decided to cut the study short for some reason (money).

[dignan]

Thanks to Bromley for pointing out that there is a simvastatin (zocor) trial for SPMS recruiting in the UK.

http://www.mssociety.org.uk/research/ta ... tatin.html

[dignan]

In the most insignificant pipeline update ever, Novartis is now selling a rebranded version of betaseron that is called extavia. I added extavia to the betaseron entry.

http://www.reuters.com/article/marketsN ... 26?sp=true

[dignan]

I added LymphoStat-B (belimumab) to phase 2 based on this press release:

http://www.hgsi.com/latest/human-genome ... tia-2.html

[rainer]

Looks like another Laquinimod Phase 2 wrapped up. Results not so hot

"In their study, the Italian team found laquinimod showed a 40 percent reduction in the mean number of inflammatory lesions of the brain that are a hallmark of the disease, compared with a placebo.

When the researchers expanded their trial by a further 12 weeks, people showed a 60 percent median reduction in the number of brain lesions, a Teva spokesman said.

A lower dose showed no statistically significant effects versus the placebo but people taking the drug tolerated both amounts, the researchers added."

http://www.reuters.com/article/rbssHeal ... 4820080619

If it were me and I found lower dose = no help and normal dose = some help... then maybe we should try jacking up the dosage?!?

[dignan]

I agree with you Rainer. But I think they are being careful because laquinimod is based on another drug, linomide, that made it to phase 3 MS trials which had to be stopped early because of "unexpected severe inflammatory side effects such as serositis and myocardial infarction."

[rainer]

minor peptimmune update:

Peptimmune Announces the Second Close of Series D Private Financing

CAMBRIDGE, Mass., July 16, 2008 /PRNewswire via COMTEX/ -- Peptimmune, Inc., a privately held biotechnology company, announced that it has completed a second close of $8.9 million of its Series D preferred stock offering with its investor syndicate led by New Enterprise Associates, MPM Capital, Hunt Ventures L.P., Boston Medical Investors and Silicon Valley Bank Capital, and its Chairman of the Board. The proceeds of the financing are primarily being used to advance clinical development of Peptimmune's PI-2301 for the treatment of multiple sclerosis.

"The Series D investment allows us to further evaluate PI-2301 in multiple sclerosis patients," stated Thomas P. Mathers, President and CEO. "The primary goal of our current Phase Ib study is to demonstrate safety of PI-2301 in multiple sclerosis patients. The Phase Ib will investigate the pharmacologic effect of PI-2301 in MS patients in the most extensive study of biomarkers in patients treated with copolymers to date."

[dignan]

Based on the info Bromley posted on the UK MS Society's latest activities, I added hookworm to the phase 2 list.

[gwa]

After looking at the Neuren Pharmaceuticals site this week and seeing that MS was no longer discussed under NNZ-2566, I emailed the CEO and asked about whether Neuren is still planning to trial the compound for MS.

He wrote me back and said that even though the results in the EAE model was good they were concentrating the drug now solely on traumatic brain injury patients, such as those who have had a stroke or injury because the results from those trials were excellent.

Since the US Army is funding this study, I imagine that money was key in their decision to go strictly with the TBI and not MS for the use of the drug.

So we have another Boo Damn Hoo now on what might have been a promising drug for MS. On the other hand, maybe there is hope for stroke patients and brain injury patients if this drug (which the FDA has fast tracked due to its efficacy in stage 2 trials) can make it to market.

gwa

[Lyon]

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[gwa]

Hi gwa,
The other night I read an article that someone on this site supplied which said that once a drug is licensed by the FDA, doctors can use it off label about any way they see fit.

With that in mind, maybe it's sometimes in our best interest to root for these drugs to go through the process in the quickest way possible and then shop for medicians who are willing to prescribe off label?

Bob

It might be a possibility, but even being in phase 111 trials now for TBI, it will still be awhile before it is produced. I am also not eager to be a guinea pig for a brain drug that has only been used on a mouse for MS purposes.

It is definitely going to take this type of drug to help all of us with MS because the meds that target only reducing lesions are missing most of the brain atrophy and debilitating aspects of the disease.

gwa

[Lyon]

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