Navigation Links
Yaupon Therapeutics Completes Patient Enrollment for Pivotal Phase 2 Study of Clearazide for Treatment of Cutaneous T-cell Lymphoma
Date:6/29/2009

Largest clinical study ever involving patients with cutaneous T-cell lymphoma on schedule for completion in June 2010

RADNOR, Pa., June 29 /PRNewswire/ -- Yaupon Therapeutics, a privately held specialty pharmaceutical company, has announced it has completed enrollment for a pivotal Phase 2 clinical trial for Clearazide for the treatment of early-stage cutaneous T-cell lymphoma (CTCL - stages 1-2a). The study, which is being conducted under a Special Protocol Assessment (SPA) with the FDA, has enrolled 260 patients in 13 of the top cancer centers in the US. Yaupon expects the last patient to complete treatment in the study by June of 2010 and, assuming positive results, will file its NDA shortly thereafter.

The randomized, double-blind, controlled clinical study is the largest ever undertaken involving patients with cutaneous T-cell lymphoma. Over one percent (1%) of all people with CTCL in the United States have enrolled in the study. There are approximately 16,000 to 20,000 patients with CTCL in the United States and each year approximately 2,000 people are newly diagnosed with the disease. If approved by FDA, Clearazide would be the first new therapy available for the treatment of early-stage CTCL in almost a decade.

"Cutaneous T-cell lymphoma, like all cancers, is a terrible burden on families worldwide. Completion of patient enrollment in this landmark study is a major milestone in our efforts to advance Clearazide through regulatory approval and to help patients with CTCL. We look forward to completing this study and filing our NDA next year," said Robert J. Alonso, Chief Executive Officer of Yaupon.

Cutaneous T-cell lymphoma is a cancer of the T-lymphocytes in the skin. Early-stage CTCL (stages 1-2a) is the most common presentation of the cancer and affects roughly 67% of the 20,000 patients with the disease. CTCL is a low-grade lymphoma and usually develops very slowly. It may be many years before it develops from one stage to the next and most people, with appropriate treatment, never progress beyond the early stages of the disease.

About Clearazide

Clearazide is a topical form of nitrogen mustard, an alkylating agent that works by inhibiting DNA replication. Nitrogen mustard has also demonstrated activity in other T-cell proliferating diseases such as psoriasis and alopecia areata and has a rich history of use in dermatology dating back to the 1950s. To date, topical nitrogen mustard has only been available through unapproved and pharmacy compounded products, creating significant access and payment issues for many patients. Clearazide is a proprietary, cosmetically-elegant topical formulation of nitrogen mustard that is made under strict pharmaceutical manufacturing processes. If approved, it will be available through standard pharmacies and managed care plans.

About Yaupon

Yaupon Therapeutics is a privately held specialty pharmaceutical company that develops small molecule pharmaceuticals licensed from under-served academic laboratories. The company has three products in development, with one compound in pivotal studies, one compound in Phase 2 and additional compounds positioned to enter clinical development in the future. The company's business strategy is to build a highly capital efficient organization that leverages the NIH competitive grant system to offset research expenses and to validate its technology. The model emphasizes strong academic collaborations that lead to the licensing and development of unique products with proof of principle and millions of academic research dollars behind them. To date Yaupon has received over $15 million in government support and over $20 million in venture capital investment.


'/>"/>
SOURCE Yaupon Therapeutics
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. DJO Incorporateds Pending Merger With ReAble Therapeutics Clears U.S. Antitrust Review
3. PeriCor Therapeutics Announces Closing of Licensing Agreement for Acadesine with Schering-Plough Corporation
4. Systems Medicine (SM), a Subsidiary of Cell Therapeutics, Inc. (CTI), Announces Execution of CRADA with NCI/NIH to Develop Potential Cancer Treatments Targeting the Insulin Growth Factor (IGF) Pathway
5. Amsterdam Molecular Therapeutics to Release H1 2007 Results on August 29, 2007
6. Nektar Therapeutics Appoints Tim Harkness as Chief Financial Officer
7. ExonHit Therapeutics: Allergan and ExonHits First Collaboration Compound to Begin Human Clinical Trials
8. Cell Therapeutics, Inc. Takes Corrective Actions in Response to Nasdaq Determination
9. Amsterdam Molecular Therapeutics Reports Half Year Results 2007
10. Nektar Therapeutics Appoints Lutz Lingnau as New Board Member
11. Anesiva Grants Specific-Use License of Its Needle-Free Drug Delivery Technology to Particle Therapeutics for Diabetes Drug
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... ... February 22, 2017 , ... ... development of precision treatments for neurodegenerative diseases, today announced it has issued a ... approach.” This is one of a series of commentaries from ProMIS’s scientific team ...
(Date:2/22/2017)... , Feb 22, 2017 Dublin ... the "Global Biological Crop Protection (Bio-Pesticide) Market-By Type, By Application, ... report to their offering. ... Global Biological Crop Protection Market is forecasted to ... The strong growth in biopesticide or biological crop protection market is ...
(Date:2/22/2017)... ... February 22, 2017 , ... NDA Partners ... MD former Acting Deputy Director in the FDA CDRH Division of Cardiovascular, Respiratory, ... joined the company as an Expert Consultant. , In Dr. Spyker’s accomplished career, ...
(Date:2/22/2017)... N.C., Feb. 22, 2017  United Therapeutics Corporation (NASDAQ: ... results for the fourth quarter and year ended ... results reflect continued growth as net revenues reached ... Martine Rothblatt, Ph.D., United Therapeutics, Chairman and Chief ... to develop and advance our growing product pipeline, ...
Breaking Biology Technology:
(Date:2/7/2017)... Minn. , Feb. 7, 2017   MedNet ... supports the entire spectrum of clinical research, is pleased ... iMedNet , its innovative, highly flexible and award ... iMedNet customers. iMedNet is a proven ... provides Electronic Data Capture (EDC), but also delivers an ...
(Date:2/3/2017)... , Feb. 3, 2017 A new independent ... Strategy Partners, LLP (IdSP) . Designed to fill a ... complex identity market, founding partners Mark Crego ... combined years just in identity expertise that span federal ... non-profit leadership. The Crego-Kephart combined expertise has a common ...
(Date:1/31/2017)... Jan. 31, 2017  Spero Therapeutics, LLC, a ... the treatment of bacterial infections, today announced it ... candidates from Pro Bono Bio Ltd (PBB) to ... multi-drug resistant forms of Gram-negative bacteria.   The assets ... Ltd, a PBB group company. "The ...
Breaking Biology News(10 mins):