Navigation Links
Gloucester Pharmaceuticals Receives Fast Track Designation for,Romidepsin in Peripheral T-Cell Lymphoma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 16, 2007 - Gloucester Pharmaceuticals, Inc., an oncology focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its novel histone deacetylase inhibitor, romidepsin, for the monotherapy of previously treated peripheral T-cell lymphoma (PTCL). The Company had previously announced that it has reached an agreement with the FDA under the FDA's Special Protocol Assessment (SPA) process for the design of its registration-directed trial of romidepsin in patients with PTCL, and that it has received Orphan Drug Status covering this indication in both the United States and Europe.

"The receipt of Fast Track Designation for PTCL is an important component of our overall product development strategy for romidepsin," commented John McBride, Executive Vice President and Chief Operating Officer at Gloucester. "We now are extremely well positioned to move forward with clinical development of romidepsin for PTCL, having previously secured Orphan Drug Designation and finalized a Special Protocol Assessment with the FDA for this indication. As a novel agent in a new class of drugs, histone deacetylase inhibitors, we believe romidepsin has significant potential as a treatment for a variety of hematological cancers as well as solid tumors," he concluded.

At the American Society of Hematology Annual Meeting held in December 2006 an interim analysis of the NCI's phase II study of romidepsin as a treatment for PTCL was presented. The interim results reported on 36 patients with PTCL. An overall response rate of 30% (11/36) was reported, with 3 complete responses (8%) and 8 partial responses (22%). The overall median duration of response has not yet been reached but was reported as being greater than 12 months. The most common adverse events reported were fatigue, nausea, and vomiting.

About Fast Track Designation

The Fast Track program is designed to facilitate and expedite the development and review of new products that demonstrate the potential to address an unmet medical need for serious or life-threatening conditions. A New Drug Application (NDA) for a Fast Track product may be submitted in sections on a rolling basis, rather than simultaneously. Fast Track designation may further lead to a priority review of an NDA within a 6 month timeframe.

About Special Protocol Assessment

A Special Protocol Assessment is a request for feedback from the FDA that allows a company to receive official evaluation and guidance on the design and size of pivotal clinical trial protocols. A company can request this formal assessment on a pivotal trial that is intended to form the primary basis of an efficacy claim in a New Drug Application (NDA).

About PTCL

Peripheral T-cell lymphoma is a term which encompasses a number of different malignancies of T-cell origin that account for about 10-15% of all cases of non-Hodgkin's lymphoma. PTCL can occur at any age from young adulthood to old age and is slightly more common in men than in women. It is a particularly aggressive form of lymphoma with a short median duration of life expectancy (approximately two years) from diagnosis.

About Romidepsin

Romidepsin is a novel agent in a new class of anti-cancer drugs known as histone deacetylase inhibitors. The Company is conducting a pivotal phase II study of romidepsin for patients with cutaneous T-cell lymphoma (CTCL) and has initiated a pivotal phase II study for patients with peripheral T-cell lymphoma (PTCL). Romidepsin has received Orphan Drug Designation from the Food and Drug Administration (FDA) for the treatment of non-Hodgkin T-cell lymphomas, which includes CTCL and PTCL. In addition, the European Agency for the Evaluation of Medicinal Products (EMEA) has issued Orphan Drug status for the treatment of both CTCL and PTCL. Fast Track s tatus for CTCL and PTCL has also been designated by the FDA. Romidepsin is in clinical trials for a variety of other hematological malignancies and solid tumors, including hormone refractory prostate cancer, pancreatic cancer and multiple myeloma. These trials and others are being conducted by the Company or the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with the Company.

About Gloucester Pharmaceuticals, Inc.

Gloucester Pharmaceuticals, Inc. is a privately-held, venture-backed company that develops and commercializes innovative products for the treatment of cancer patients. Gloucester is headquartered in Cambridge, MA. For more information on Gloucester and our clinical development program visit our website at www.gloucesterpharma.com or call 888-474-2825.

Contact

Media:
KMorrisPR
Kathryn Morris, 845-635-9828
kathryn@kmorrispr.com
or
Gloucester Pharmaceuticals
Beverly Holley, 617-583-1362
beverly.holley@gloucesterpharma.com


'"/>




Related medicine technology :

1. Gloucester Pharmaceuticals Reports Positive Interim Phase II Data on Romidepsin for T-Cell Lymphomas at the 2007 American Society of Clinical Oncology Annual Meeting
2. Gloucester Pharmaceuticals Reports on Romidepsin and Erlotinib Combination in Non-Small Cell Lung Cancer Presented at American Association of Cancer Research Annual Meeting
3. Gloucester Pharmaceuticals Announces Multiple Presentations of Preclinical Romidepsin Data at American Association of Cancer Research Annual Meeting
4. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
5. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
6. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
7. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
8. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
9. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
10. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
11. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... , Feb. 5, 2016  ivWatch, a medical devices company, ... STEM Award granted by Governor Terry McAuliffe,s office. ... on February 25th at an event to be held at ... STEM award honors professionals and business that have made significant ... Logo - http://photos.prnewswire.com/prnh/20160205/330117LOGO ...
(Date:2/5/2016)... , Feb. 5, 2016  Aralez Pharmaceuticals Inc. ("Aralez") ... POZEN Inc. ("POZEN") and Tribute Pharmaceuticals Canada Inc. ("Tribute") following ... shareholders of Tribute. The combined company will operate under ... with operations in Canada , ... States . Under the terms of the Agreement ...
(Date:2/5/2016)... , Feb. 5, 2016  Venice,s newest laser ... the first of its kind in the area ... through advanced laser treatment. The physician-owned and operated ... Suncoast by storm with its revitalizing skin ... advanced multi-wavelength Astanza Trinity technology. http://photos.prnewswire.com/prnh/20160204/329957 ...
Breaking Medicine Technology:
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... CURE ... patients, has officially launched the Multiple Myeloma Heroes Awards event , which will ... in the lives of patients with MM. The MM Heroes Awards nomination process ...
(Date:2/8/2016)... , ... February 08, 2016 , ... ... its newly redesigned website, federallabs.org . The site houses a wealth of ... available federal technologies through the process called technology transfer (T2). As a network ...
(Date:2/8/2016)... PA (PRWEB) , ... February 08, 2016 , ... ... expanded authorization with BASF Human Nutrition into the Food & Beverage ... BSI has been BASF’s channel partner throughout Canada and USA geographies east of ...
(Date:2/8/2016)... , ... February 08, 2016 , ... Coast Dental has ... is National Children’s Dental Health Month and family dentist Yvonne Dorrian, DMD, is hosting ... Coast Dental , located next to Target at 1207 North Peachtree Parkway in ...
(Date:2/8/2016)... ... February 08, 2016 , ... Stephanie Hebert Insurance Agency, ... of a new charity campaign. As part of their ongoing community involvement program, ... the belief that children deserve a voice, and in the spirit of neighbors ...
Breaking Medicine News(10 mins):