Provectus Pharmaceuticals Initiates New PH-10 Clinical Study for Psoriasis
Monday July 20, 2009
Study Includes Once Daily Treatment for 28 Days
Dermatology Products Now Available For Licensing or Co-Development
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Pharmaceuticals, Inc. (OTCBB:
PVCT,
http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company,
has initiated a new Phase 2 clinical trial of PH-10 for psoriasis involving daily dosing of patients for 28 days. After reviewing safety and efficacy
data from its PH-10 trial for atopic dermatitis, Provectus determined that daily dosing of patients with psoriasis trial would be an appropriate and
attractive regimen. The new study supplants an earlier Phase 2 study, using twice weekly dosing for 12 weeks, which was terminated earlier in June.
Preliminary analysis of the data from the first six psoriasis patients to complete the earlier Phase 2 study showed that repeat treatment with PH-10 was safe,
with evidence of efficacy noted in some subjects. This analysis, combined with the data obtained from the on-going atopic dermatitis study, indicated
that increased dosing frequency was appropriate for psoriasis. The new protocol replaces twice weekly application of PH-10 with daily application.
Enrollment in the new trial has commenced and the first patients have begun active participation at the first clinical site in Miami, FL. Patients
interested in participating in the trial may find further information at the NIH clinical trials registry,
www.clinicaltrials.gov or at www.pvct.com.
Craig Dees, Ph.D., CEO of Provectus said, "PH-10 differs from most other advanced therapies for chronic skin conditions, like atopic dermatitis and
psoriasis, because its topically applied, confining effects to diseased skin. This approach can improve efficacy and largely eliminates any potential for
systemic side effects that have accompanied many recent systemic therapies."
Dees concluded, "With this improved protocol that we believe will support robust data in a second dermatology indication, we have reached the point in
the development of PH-10 where we are ready for either a licensing or co-development partnership. Therefore, part of our efforts in the months ahead
will involve exploring these possibilities with major parties in the dermatology sector, while simultaneously continuing our clinical trials."
According to the National Institutes of Health, as many as 7.5 million Americans, approximately 2.2 percent of the population, have psoriasis. The
National Psoriasis Foundation reports that approximately 125 million people worldwide, 2 to 3 percent of the total population have psoriasis. It also
reports that total direct and indirect health care costs of psoriasis for patients are approximately $11.25 billion annually.
About Provectus Pharmaceuticals, Inc. (www.pvct.com)
Provectus Pharmaceuticals is a development stage company that specializes in oncology and dermatology therapies that are safer, more effective,
less invasive and more economical than conventional therapies. Provectus is currently conducting Phase 2 clinical trials of its proprietary
drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. Information about
these and the Company's other clinical trials can be found at the NIH registry,
www.clinicaltrials.gov.
The Company has received orphan drug designation from the FDA for its melanoma indication. Complementing their suite of
proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging,
medical devices and biotechnology. For additional information about Provectus please visit the Company's website at
www.pvct.com or contact Porter, LeVay & Rose, Inc.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.
Contact:
Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO & COO, 866-594-5999 #30
or
Porter, LeVay & Rose, Inc.
Marlon Nurse, VP Investor Relations
Bill Gordon, SVP Media Relations
212-564-4700
