MALVERN, Pa.--()--Ceptaris Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today that the results of a pivotal trial comparing its proprietary gel formulation of mechlorethamine hydrochloride 0.02% to pharmacy-compounded mechlorethamine ointment for the treatment of early stage mycosis fungoides (MF), the most common form of cutaneous T-cell lymphoma (CTCL), have been published in JAMA Dermatology (formerly Archives of Dermatology).1
Topical mechlorethamine preparations are currently recommended as first line-treatment for early stage CTCL by the National Comprehensive Cancer Network (NCCN). However, there are no FDA approved topical mechlorethamine products, limiting availability to non-standardized, pharmacy-compounded preparations.
The pivotal trial was a randomized, observer-blinded clinical study designed to determine if mechlorethamine gel was non-inferior to a pharmacy-compounded ointment in patients with MF. The study enrolled 260 patients at 13 U.S. centers and is the largest randomized trial ever conducted in patients with stages IA, IB and IIA MF.
The study met or exceeded the pre-specified criteria for non-inferiority. Most adverse events related to mechlorethamine gel were characterized as local skin irritation. Approximately 20 percent of mechlorethamine gel-treated patients withdrew from the study because of these events.
The Company is planning a US resubmission in early 2013 and a MAA submission in the EU for mid-2013.
About Ceptaris Therapeutics
Ceptaris Therapeutics, Inc. is a privately held, specialty pharmaceutical company that is developing a proprietary gel formulation of mechlorethamine hydrochloride for the treatment of early stage (stages I-IIA) mycosis fungoides, a type of Cutaneous T-Cell Lymphoma (CTCL). If approved, Ceptaris's investigational drug would be the first topical mechlorethamine product available to treat the signs and symptoms of this rare cancer. Please visit http://www.ceptaris.com for more information.
This release includes forward-looking statements concerning the Company's pivotal study evaluating the efficacy and tolerability of mechlorethamine gel compared to pharmacy-compounded ointment in patients with stages IA, IB and IIA MF, including expectations regarding related regulatory filings. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality or patient safety issues. The information contained in this press release was accurate at the time of issuance and Ceptaris assumes no responsibility for updating the information to reflect subsequent developments.
1 Lessin SR, Duvic M, Guitart J, et al. Topical chemotherapy in cutaneous t-cell lymphoma: Positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol. 2013;149(1): 25-32.
Copyright© 2013 Ceptaris Therapeutics, Inc. All rights reserved. This information is intended only for residents of the United States.