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Cytokinetics' Amyotrophic Lateral Sclerosis Study Enrolled
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Cytokinetics, Incorporated (CYTK - Free Report) announced that it has completed patient enrollment in the phase III study VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS) on its lead pipeline candidate, tirasemtiv, for the treatment of amyotrophic lateral sclerosis (ALS).
The multi-national, randomized, double-blind, placebo-controlled study is being conducted to evaluate the effects of tirasemtiv, in comparison to placebo, on slow vital capacity and other measures of skeletal muscle strength in patients with ALS. Data from the study are anticipated in the second half of 2017.
Patients enrolled in VITALITY-ALS are also eligible to participate in an open-label extension study on tirasemtiv. Enrollment in the open-label extension study is expected to begin in the fourth quarter of 2016.
We are encouraged by Cytokinetics’ progress with the candidate. Per the company’s press release, ALS affects about 30,000 people in the U.S. and a comparable number of patients in Europe. Also, roughly 6,000 new cases of ALS are diagnosed each year in the U.S.
Considering the poor survival rates, there exists significant unmet need for drugs addressing this progressive neurodegenerative disease. We note that tirasemtiv has been granted both orphan drug status and fast track status by the FDA, and orphan medicinal product designation by the European Medicines Agency for the treatment of ALS.
Cytokinetics retains the right to develop and commercialize tirasemtiv, subject to an option held by Astellas Pharma, Inc. (ALPMY - Free Report) .
Apart from tirasemtiv, Cytokinetics has another skeletal muscle activator, CK-2127107, and a cardiac muscle activator, omecamtiv mecarbil, in its pipeline. The company is collaborating with Astellas for the development of CK-2127107 for the treatment of spinal muscular atrophy, chronic obstructive pulmonary disease and ALS.
Meanwhile, Cytokinetics is collaborating with Amgen Inc. (AMGN - Free Report) for the development of omecamtiv mecarbil for the treatment of heart failure.
We expect investor focus to remain on pipeline updates from the company.
Cytokinetics is a Zacks Rank #2 (Buy) stock. Another favorably placed stock in the healthcare sector is Actelion Ltd. , sporting a Zacks Rank #1 (Strong Buy).
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Cytokinetics' Amyotrophic Lateral Sclerosis Study Enrolled
Cytokinetics, Incorporated (CYTK - Free Report) announced that it has completed patient enrollment in the phase III study VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS) on its lead pipeline candidate, tirasemtiv, for the treatment of amyotrophic lateral sclerosis (ALS).
The multi-national, randomized, double-blind, placebo-controlled study is being conducted to evaluate the effects of tirasemtiv, in comparison to placebo, on slow vital capacity and other measures of skeletal muscle strength in patients with ALS. Data from the study are anticipated in the second half of 2017.
Patients enrolled in VITALITY-ALS are also eligible to participate in an open-label extension study on tirasemtiv. Enrollment in the open-label extension study is expected to begin in the fourth quarter of 2016.
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We are encouraged by Cytokinetics’ progress with the candidate. Per the company’s press release, ALS affects about 30,000 people in the U.S. and a comparable number of patients in Europe. Also, roughly 6,000 new cases of ALS are diagnosed each year in the U.S.
Considering the poor survival rates, there exists significant unmet need for drugs addressing this progressive neurodegenerative disease. We note that tirasemtiv has been granted both orphan drug status and fast track status by the FDA, and orphan medicinal product designation by the European Medicines Agency for the treatment of ALS.
Cytokinetics retains the right to develop and commercialize tirasemtiv, subject to an option held by Astellas Pharma, Inc. (ALPMY - Free Report) .
Apart from tirasemtiv, Cytokinetics has another skeletal muscle activator, CK-2127107, and a cardiac muscle activator, omecamtiv mecarbil, in its pipeline. The company is collaborating with Astellas for the development of CK-2127107 for the treatment of spinal muscular atrophy, chronic obstructive pulmonary disease and ALS.
Meanwhile, Cytokinetics is collaborating with Amgen Inc. (AMGN - Free Report) for the development of omecamtiv mecarbil for the treatment of heart failure.
We expect investor focus to remain on pipeline updates from the company.
Cytokinetics is a Zacks Rank #2 (Buy) stock. Another favorably placed stock in the healthcare sector is Actelion Ltd. , sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>