|Aldeyra Provides Update on NS2 Clinical Program; Acasti Receives Full Data for Phase II TRIFECTA Trial|
|By Josh Gee|
|Monday, 02 March 2015 19:49|
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX), provided an update on its planned clinical trial programs in noninfectious anterior uveitis and Sjögren-Larsson Syndrome, as part of its webcast presentation at the Cowen and Company 35th Annual Healthcare Conference on Monday, March 2, 2015 at 4:50 p.m. ET.
Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, commented, "As we work to finalize the clinical trial protocol in both noninfectious anterior uveitis and Sjögren-Larsson Syndrome, we have remained in close contact with the FDA. Based on their requirements, we have amended and submitted an updated trial protocol for noninfectious anterior uveitis with regard to the severity of patients and the frequency of dosing. We believe that the updated protocol will satisfy these requirements and, pending FDA and IRB review, we remain on track to generate data from both of our clinical programs in 2015."
The U.S. FDA has notified Aldeyra that, before initiation of Aldeyra's planned Phase II clinical study of NS2 in patients with noninfectious anterior uveitis, the protocol submitted as part of the company's Investigational New Drug Application requires amending. Aldeyra has submitted an amended protocol that the Company believes will be acceptable to the FDA. Specifically, in the amended protocol, a minority subset of the most severe uveitis patients are excluded from enrollment, and the frequency of dosing was reduced to treat less severe disease and match the dosing frequency employed in the Phase I study. Consistent with earlier guidance, and subject to FDA review of the modified protocol, the trial is expected to begin enrollment in the first half of 2015, with preliminary data available by the end of the year.
The company's Phase II clinical trial of a dermatologic formulation of NS2 to treat ichthyosis and other skin manifestations of Sjögren-Larsson Syndrome is expected to begin enrollment pending final Institutional Review Board (IRB) approval. Consistent with earlier guidance, final data from the trial are expected in the second half of 2015.
NS2 is an aldehyde-binding small molecule based on an innovative platform technology focused on trapping free aldehydes, which are toxic and pro-inflammatory mediators of numerous diseases. By decreasing aldehyde load, NS2 may mitigate pathologic inflammation and address other diseases where aldehydes are thought to mediate pathology.
Acasti Pharma Inc. (NASDAQ: ACST), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces that it has received full data for its Phase II double blind, placebo controlled (TRIFECTA) trial.
The full set of data further confirms and supports the positive Phase II TRIFECTA results announced in September 2014, on the safety and efficacy of CaPre® in the treatment of patients with hypertriglyceridemia. As previously announced, the TRIFECTA trial's primary endpoint was met, with patients on 1 gram or 2 grams of CaPre® achieving a statistically significant mean placebo-adjusted decrease in triglycerides from baseline. In addition, benefits in other key cholesterol markers were announced, including slight increases in HDL-C (good cholesterol), no deleterious effect on LDL-C (bad cholesterol) and no safety concerns.
With full data, Acasti is now able to meet with the US Food and Drug Administration (FDA) to discuss next steps in the clinical development of CaPre®. The meeting is expected to take place in the Corporation's first quarter, ending May 31, 2015. "With the encouraging results announced to date, we are well positioned to move forward with our clinical program, including a pivotal Phase III trial for CaPre® in patients with severe hypertriglyceridemia," said Pierre Lemieux, PhD, Acasti's Chief Operating Officer. "In anticipation that we will eventually receive approval to conduct a Phase III trial, we are ramping up production of CaPre® clinical material, using current Good Manufacturing Practices, to ensure a quality product in sufficient quantities is available. This will allow us to avoid any delays due to inventory shortages."
3D Systems (NYSE:DDD) announced today it has entered into a multi-national distribution agreement with Henry Schein, Inc. (Nasdaq:HSIC), the world's largest provider of healthcare products and services to office-based dental, animal health and medical practitioners.
Aldeyra Therapeutics, Inc. (Nasdaq:ALDX), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today provided an update on its planned clinical trial programs in noninfectious anterior uveitis and Sjögren-Larsson Syndrome, as part of its webcast presentation at the Cowen and Company 35th Annual Healthcare Conference on Monday, March 2, 2015 at 4:50 p.m. ET.
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Mesa Laboratories, Inc. (Nasdaq:MLAB) today announced the acquisition of certain assets and liabilities of two of its European distributors by Amilabo SAS, the Company's subsidiary located near Lyon, France.
Micron Products, Inc., a wholly-owned subsidiary of Arrhythmia Research Technology, Inc. (NYSE MKT:HRT), announced today it has appointed medical device industry professional Michael Collette as the Company's Vice President of Quality, effective February 16, 2015.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that results from preclinical studies on its hyper-sialylated IVIg (hsIVIg) program were published in this week's Early Edition of Proceedings of the National Academy of Sciences (PNAS).
Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that Mark Capone, president of Myriad Genetic Laboratories, is scheduled to present at the Barclays Global Healthcare Conference at 11:15 a.m. Eastern on March 11, 2015, at Loews Miami Beach Hotel in Miami Beach, Florida.
NantHealth and Allscripts (Nasdaq:MDRX) will collaborate on the development and delivery of cutting-edge, precision medicine solutions directly to the point of care.
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Perseon Corporation (Nasdaq:PRSN), a leading provider of medical systems that utilize heat therapy to treat cancer, today announced that its Board of Directors is exploring strategic options to enhance shareholder value.
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