Yaupon Therapeutics Completes Patient Enrollment for Pivotal Phase 2 Study of Clearazide...

* Reuters is not responsible for the content in this press release.

Mon Jun 29, 2009 8:30am EDT

Yaupon Therapeutics Completes Patient Enrollment for Pivotal Phase 2 Study of
Clearazide for Treatment of Cutaneous T-cell Lymphoma

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

Jarrod Aldom, Berry & Co, Public Relations, +1-212-253-8881,
jaldom@berrypr.com
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.