|Aclaris Announces Positive Results from Phase 2b Clinical Trial of A-101; FDA Accepts CTD Holdings' Drug Master File|
|By Josh Gee|
|Tuesday, 27 January 2015 19:45|
Aclaris Therapeutics, Inc. announced positive results from a Phase 2b clinical trial of the Company’s lead drug, A-101. In the trial, A-101 demonstrated clinically and statistically significant improvements in clearing multiple seborrheic keratoses (SK), one of the most common types of skin tumors. Though the lesions are benign, many patients elect to have SK treated, either because the lesions are irritated or are cosmetically concerning.
The double-blind, vehicle-controlled Phase 2b clinical trial was designed to evaluate the safety, tolerability and efficacy of A-101 in removing multiple SK lesions on the trunk and extremities. The trial used a parallel-group design to compare two concentrations of A-101 and vehicle (placebo) in 172 subjects with SK lesions. Results from the study showed A-101 achieved statistical significance in clearing SK lesions in a dose-related fashion. A-101 was well tolerated at both concentrations studied.
“This positive outcome represents an important milestone for A-101 and further demonstrates its potential as a non-invasive treatment for SK, a condition for which there are currently no FDA-approved therapies”, said Dr. Neal Walker, President and CEO of Aclaris. “These findings, along with results from a second, ongoing Phase 2b study to evaluate A-101 in treating SK lesions on the face, will be used to support the progression of A-101 into Phase 3 trials. Results from the second Phase 2b study are expected later this quarter.”
SK are among the most common skin tumors seen in middle-aged and older adults, affecting approximately 83 million people in the U.S.1 SK lesions have a waxy, scaly, slightly elevated appearance and often multiple growths are present. Currently, SK lesions are treated using modalities such as cryosurgery, electrosurgery, curettage, or surgical removal which may be painful and may often result in pigmentary changes and/or scarring at the treatment site.
“These study results are promising and suggest that A-101 may have the potential to address an unmet medical need,” said Janet DuBois, MD, a dermatologist in Austin, TX and an investigator on multiple A-101 clinical trials. “While cryotherapy is the most commonly used treatment for the removal of SK lesions, it is painful for patients and sometimes results in permanent hypopigmentation. A well-tolerated, FDA-approved, non-invasive treatment option for SK would be a welcome advance for patients and physicians.”
CTD Holdings, Inc. (OTCQB: CTDH), announced that the U.S. Food and Drug Administration accepted CTD's Type II Drug Master File No. 28889 covering its second-generation Trappsol® Cyclo™ orphan drug product.
The file allows clinicians and researchers to cite the drug in Investigational New Drug applications (INDs) and request FDA approval for compassionate use treatment of Niemann-Pick Type C, a genetic disease that is often fatal in young children.
"This Drug Master File is the result of work that began in 2012, and it lays the foundation for building our clinical program and expanding availability of this important treatment for Niemann-Pick Type C," said Dr. Jeffrey Tate, President and CEO of CTD.
First-generation Trappsol® Cyclo™ is in powder form. Second-generation Trappsol® Cyclo™ is a proprietary, ready-to-use sterile liquid solution that improves safety, enables precise dosing, and allows treatment without the services of a compounding pharmacist. CTD's Sphingo Biotechnology division will provide the drug to physicians and researchers whose INDs have received FDA approval. The product is being used under similar regulatory regimens in Europe and South America to treat Niemann-Pick Type C.
Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported third quarter fiscal 2015 revenue of $62.0 million, up 34% compared to revenue of $46.2 million in the same period of fiscal 2014, and a third quarter fiscal 2015 GAAP net income of $12.7 million, or $0.30 per diluted share, compared to $4.4 million, or $0.11 per diluted share, in the prior year period.
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, announced that today, January 27, 2015, the United States Patent and Trademark Office (USPTO) issued to Apricus, U.S. Patent No. 8,940,794, titled "METHODS AND COMPOSITIONS FOR TREATING RAYNAUD'S DISEASE," with claims generally directed to methods for treating Raynaud's phenomenon, that is secondary to systemic sclerosis.
Abiomed Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that the Impella RP® (Right Percutaneous) System has received U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE).
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CNS Response, Inc. (OTCQB:CNSO) has been notified we will be featured on the Friday, January 30 episode of "The Doctors."
Global Payout, Inc. (OTC Pink: GOHE), a leading provider of international electronic payment solutions, announced today a new contract award in Mexico from Vizinova S.A. de C.V., a high-tech international e-commerce firm.
Glucose Health, Inc. (OTC:GLUC) today announced the filing of its initial application for trademark protection related to its Glucose Health line of dietary products, with the United States Trademark and Patent Office www.uspto.gov (USPTO).
Greatbatch, Inc. (NYSE:GB) announced today that it will host a conference call on Tuesday, February 24, 2015 at 5:00 p.m. E. T. to discuss its financial results for the fourth quarter 2014 ended January 2, 2015.
Healthcare Services Group, Inc.'s (Nasdaq:HCSG) Board of Directors has declared a quarterly cash dividend of $0.17625 per common share, payable on March 27, 2015 to shareholders of record at the close of business on February 20, 2015.
INC Research Holdings, Inc. (Nasdaq:INCR), a leading, global Phase I to IV contract research organization, will release its fourth quarter and full-year 2014 financial results on Tuesday, Feb. 24, 2015, prior to its quarterly earnings call at 8:00 a.m. EST.
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, announced today that in honor of International Holocaust Remembrance Day 2015, the Company is donating an Inogen One G3 portable oxygen concentrator to Holocaust Survivor, Ben Fainer.
Lombard Medical, Inc. (Nasdaq:EVAR), a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced the initiation of the ARCHYTAS global registry.
Macrocure Ltd. (Nasdaq:MCUR), a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that at 10:30 AM ET on Tuesday, February 10, 2015, Mr. Nissim Mashiach, Macrocure's President and Chief Executive Officer, will present at the 17th Annual BIO CEO & Investor Conference in New York City.
Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions, today announced that Peter Wrighton-Smith Ph.D., Chief Executive Officer, and Rick Altieri, Chief Financial Officer, will present at the 2015 Leerink Global Healthcare Conference at the Waldorf Astoria Hotel in New York, New York on Wednesday, February 11, 2015 at 2:40 pm ET.
The Spectranetics Corporation (Nasdaq:SPNC) today announced it has completed the acquisition of Covidien's Stellarex™ drug coated balloon angioplasty (DCB) platform.