Cytokinetics ($CYTK) announces CK-2017357 receives fast track designation from the FDA for the potential treatment of amyotrophic lateral sclerosis

Cytokinetics (NASDAQ: CYTK) announced that CK-2017357, its fast skeletal muscle troponin activator, has received Fast Track designation from the FDA for the potential treatment of amyotrophic lateral sclerosis (ALS), also commonly known as Lou Gehrig's Disease.

• Cytokinetics anticipates that results from two recently completed Phase II clinical trials, designed to assess the safety and tolerability of CK-2017357 in patients with ALS, will be presented at the American Academy of Neurology 64th Annual Meeting in New Orleans, LA on April 25, 2012.
• Cytokinetics has met with the FDA's Division of Neurology Products and with the European Medicines Agency to discuss its progress in the development of CK-2017357 as a potential treatment for patients with ALS and the company's plans for its further development, including potential registration strategies.
• Cytokinetics is assessing options that may enable the initiation of a registration program for CK-2017357.
• Cytokinetics anticipates having additional interactions with U.S. and European regulatory authorities during 2012 to discuss the development of CK-2017357 as a potential treatment for patients with ALS, including potential registration strategies.

Daily Dose Conclusion: New treatments for ALS and competition could pressure cell therapy company Neuralstem (CUR).

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$ CUR - Neuralstem ALS Stem Cell Trial Results Reported in, STEM CELLS

Neuralstem (AMEX: CUR) is working on Fetal Derived cells for Lou Gehrig’s disease. The company received a lot of press a few years ago when CNN (Sanjay Gupta) featured the treatment.

• The company announced that safety results from the first 12 patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) to receive its stem cells were reported online in the peer-reviewed publication, STEM CELLS, on 13-Mar.
• The report was titled "Lumbar Intraspinal Injection of Neural Stem Cells in Patients with ALS: Results of a Phase I Trial in 12 Patients".
• One patient has shown improvement in his clinical status, even though researchers caution that the study was not designed to show efficacy.
• There was no evidence of accelerated disease progression due to the intervention in any of the 12 patients, who were followed from 6-18 months after they were transplanted with the cells.
• All of the patients, who received transplants in the lumbar (lower back) region, tolerated the treatment without any long-term complications related to either the surgery or the cells.

See the full press release.

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Click here to download Flash Player noThe company announced that safety results from the first 12 patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) to receive its stem cells were reported online in the peer-reviewed publication, STEM CELLS, on 13-Mar.he company announced that safety results from the first 12 patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) to receive its stem cells were reported online in the peer-reviewed publication, STEM CELLS, on 13-Mar.

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Neuralstem (AMEX: CUR): Raising Capital while Pursuing Gehrig's Disease

Neuralstem (AMEX: CUR) is set to raise $5.2M in a registered direct offering through T.R. Winston & Company. The company announced the agreement for a registered direct placement (5.2M shares of common) at a price of $1.00 per share or "at the market". Each investor will also receive a warrant to purchase a number of shares of common stock equal to the number of shares purchased by the investor in the offering or 1:1, with the offering set to close February 10, 2012.

Neuralstem is working on Fetal Derived cells for Lou Gehrig’s disease. The company received a lot of press on this program a few years ago when CNN (Sanjay Gupta) featured the treatment. Our concern in that this is a very tough disease to show efficacy and the regulatory pathway is anything but clear, certainly long and expensive. While ALL (Lou Gehrig’s Disease) is an unmet medical need, and the payoff could be large, it’s more likely than not, that the effect will be modest (this is a very debilitating, progressive, fatal disease) so definitive proof of concept will likely require a lot of patients and time.

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