Aldeyra Provides Update on NS2 Clinical Program; Acasti Receives Full Data for Phase II TRIFECTA Trial Print
By Josh Gee   
Monday, 02 March 2015 19:49
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 2, 2015.

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

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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.


 

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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."


 
Also Monday:


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.

Bacterin International Holdings, Inc. (NYSE MKT:BONE)
, a leader in the development of revolutionary bone graft material, today announced that it will release its financial results for the period and full year ended December 31, 2014, on March 17, 2015 at the close of the financial markets.

Biocept, Inc. (Nasdaq:BIOC)
, a molecular oncology diagnostics company specializing in biomarker analysis of cell-free circulating tumor DNA and circulating tumor cells (CTCs), today announced that David Rimm, M.D., Ph.D., Professor of Pathology and Professor of Medicine in Medical Oncology at Yale University School of Medicine, will join the Company as a scientific advisor.

Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR)
, a leader in functional, renewable plant proteins, has been invited to present at the 27th Annual ROTH Conference being held March 8 – 11, 2015 at the Ritz Carlton in Dana Point, California.

Curis, Inc. (Nasdaq:CRIS)
, announced today the closing of its previously announced public offering of common stock. Curis sold 25,090,908 shares of its common stock in the offering at a price to the public of $2.75 per share, including the exercise in full by the underwriters of their option to purchase an additional 3,272,727 shares of common stock at the public offering price.

Endocyte, Inc. (Nasdaq:ECYT)
, a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced financial results for the fourth quarter ending December 31, 2014, and provided a clinical update.

Galectin Therapeutics (Nasdaq:GALT)
, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that Harold, Shlevin, Ph.D, chief operating officer, will present a corporate overview and update at the 27th Annual ROTH Conference on March 9, 2015 at 11:00 a.m. Pacific time.

Herborium® Group, Inc.(OTC Pink: HBRM)
, a Botanical Therapeutics® Company providing unique, all botanical medicines (Botanical Therapeutics®), announced today its 2014 financial results.

Hemispherx Biopharma, Inc. (NYSE MKT:HEB)
announced today that its manufacturing site located in New Brunswick, New Jersey, presently configured at over 43,000 square feet, has completed its $8 million of upgrades.

iCAD, Inc. (Nasdaq:ICAD)
, an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that Ken Ferry, Chief Executive Officer, will present at the 27th Annual ROTH Conference at The Ritz Carlton in Dana Point, CA.

Kite Pharma, Inc., (Nasdaq:KITE)
, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the Company has amended its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI).

Lion Biotechnologies, Inc. (Nasdaq:LBIO)
announced that president and CEO Elma Hawkins, PhD, will present at Cowen and Company's 35th Annual Healthcare Conference on Wednesday, March 4, 2015.

Medgenics, Inc. (NYSE MKT:MDGN)
, the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that Michael Cola, President and CEO, will present at two upcoming investor conferences.

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.

NeoStem, Inc. (Nasdaq:NBS)
, a biopharmaceutical company developing novel, cell-based personalized medicine therapies, announced today 2014 year end results and provided an update on its business.

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.

Radius Health, Inc. (Nasdaq:RDUS)
, a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers, announced today the appointment of Tony Rosenberg to its Board of Directors.

Relypsa, Inc. (Nasdaq:RLYP)
, today announced that Kristine M. Ball, senior vice president and chief financial officer, will present at the 27th Annual ROTH Conference on March 10, 2015 at 9:30 a.m. PT.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a specialty biopharmaceutical company developing botulinum toxin products for the use in aesthetic and therapeutic indications, announced today financial results for the fourth quarter and full year ended December 31, 2014.

Signal Genetics, Inc. (Nasdaq:SGNL)
, a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer, today announced that the underwriters of its recent public offering have exercised their option to purchase an additional 482,142 shares of its common stock at a price of $2.80 per share.

Surgical Care Affiliates, Inc. (Nasdaq:SCAI)
today announced that it will release its fourth quarter and full year 2014 financial results before market open on Tuesday, March 10, 2015.

TG Therapeutics, Inc. (Nasdaq:TGTX)
today announced that Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, will present at the Cowen and Company 35th Annual Health Care Conference, being held at the Boston Marriott Copley Place Hotel, in Boston, MA.

TOMI™ Environmental Solutions, Inc. (OTCQB:TOMZ)
, a global bacteria and infectious disease control company, announced today that it has entered into a sales agency agreement with Espire Health Philippines, Inc. ("Espire Health").



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