January 24, 2015 11:45 PM ET

Pharmaceuticals

Company Overview of Ceptaris Therapeutics, Inc.

Company Overview

Ceptaris Therapeutics, Inc. develops mechlorethamine gels. The company develops a gel formulation of mechlorethamine hydrochloride for the treatment of early stage (stages I-IIA) mycosis fungoides, a type of Cutaneous T-Cell Lymphoma. Ceptaris Therapeutics, Inc. was formerly known as Yaupon Therapeutics, Inc. and changed its name to Ceptaris Therapeutics, Inc. in January 2012. The company was founded in 2002 and is based in Malvern, Pennsylvania. As of September 19, 2013, Ceptaris Therapeutics, Inc. operates as a subsidiary of Actelion US Holding Company.

101 Lindenwood Drive

Suite 400

Malvern, PA 19355

United States

Founded in 2002

Phone:

610-975-9290

Fax:

610-975-9012

Key Executives for Ceptaris Therapeutics, Inc.

Chairman and Chief Executive Officer
Chief Financial Officer and Chief Operating Officer
Head of Research & Development and Executive Vice President
Age: 55
Senior Vice President of Business Development
Vice President of Project Management and Operations
Compensation as of Fiscal Year 2014.

Ceptaris Therapeutics, Inc. Key Developments

Ceptaris Therapeutics Inc. Receives US FDA Approval for VALCHLOR

Actelion highlighted the announcement from Ceptaris Therapeutics Inc., which stated that the US Food and Drug Administration (FDA) has granted marketing approval for VALCHLOR (mechlorethamine) Gel 0.016% for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin directed therapy.

Ceptaris Announces Publication in JAMA Dermatology of Positive Clinical Results for Mechlorethamine Gel in Early Stage Mycosis Fungoides

Ceptaris Therapeutics Inc. announced 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). 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 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% of mechlorethamine gel-treated patients withdrew from the study because of these events.

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