|
20/07/2006
Foamix’s Betamethasone Foam Demonstrates High Efficacy in
Psoriasis Treatment and 85% Better Usability
than Cream in Phase I/II Study
Ness Ziona, Israel, Thursday, July 20, 2006 --- Foamix Ltd. (www.foamix.co.il)
announced today the results of its Phase I/II study of Betamethasone Valerate 0.12%
foam, for the treatment of psoriasis. Data demonstrated that the foam is efficacious
and safe. Patients also rated the foam as better than the respective cream for the
following usability parameters: skin absorption, oily residue, shiny look after
treatment, stickiness and odor.
Psoriasis is a chronic skin disease that, according to the National Institutes of Health
(NIH), affects between 5.8 and 7.5 million Americans. The World Psoriasis Day
Consortium reported that a total of 125 million people worldwide suffer from this skin
condition. The most common form, plaque psoriasis, appears as raised, red patches or
lesions covered with a silvery white buildup of dead skin cells, called scale.
The study titled, “A Randomized, Single (investigator) Blind, Right-Left Comparison
within Patient Design, to Evaluate the Therapeutic Efficacy and Safety of Topically
Applied 0.12% Betamethasone Valerate Foam in Comparison with Betnovate Cream,
in Plaque Type Psoriatic Patients”, was conducted at the Laniado Medical Center in
Netanya, Israel.
“Both the foam and the cream proved effective. After three weeks of treatment, there
was a functionally and statistically significant improvement from baseline in all
efficacy parameters. More than 84% of study participants experienced significant
improvement. Notably, in terms of usability, there was a clear difference. Study
participants reported a preference for the foam noting it absorbed into the skin faster
and did not leave any unpleasant byproducts, as did the cream. Dermal side effects
were negligible in this study,” said Principal Investigator Dr. Avner Shemer.
Thirty healthy adults, between 18 to 80 years of age, were included in the study. All
were diagnosed with bilateral plaque-type psoriasis for at least one year. Two similar
plaque areas of psoriasis were selected for treatment on each patient. Patients applied
test preparation (Foamix Betamethasone Valerate 0.12% in an emollient foam
vehicle) or the control cream, according to the randomization protocol, to the test
plaque area twice daily, for six weeks.
“Treatment compliance is a major issue for most suffering from psoriasis. The
available creams require extensive rubbing to apply, take time to absorb and leave an
unpleasant after-feeling and odor. As a result, patients choose to live with their
condition, rather than to treat it. We believe that the introduction of an effective,
instantly absorbed foam product, without the noted byproducts of cream, will not only
help to reverse the downward slide in condition treatment, but catapult it significantly
upward,” said Foamix CEO Dr. Dov Tamarkin.
"This is a new petrolatum-free, non-greasy emollient foam, which maintains skin
hydration without occluding the skin or clogging skin pores. And, it contains no
alcohol, which is the reason for its favorable safety profile", he added.
Foamix also announced today that it will be exhibiting and presenting at the American
Academy of Dermatology (AAD), July 26-30, 2006 at the San Diego Convention
Center/Marriott in San Diego, California.
About Foamix
Headquartered in Ness Ziona, Israel, Foamix Ltd. develops alcohol-free, stable foam
products for prescription, Over-the-Counter and cosmetic uses. Foamix’s state-of-theart
foams provide controlled delivery of a variety of active ingredients. They are also
able to enhance intradermal delivery of actives, for optimal effect. The Company’s
development capabilities range from initial development of foam formulations to
scale-up, GMP manufacturing, preclinical trials and clinical studies. The Company
was founded in January 2003 by CEO Dr. Dov Tamarkin, COO Mr. Meir Eini and
Chief Technology Officer Dr. Doron Friedman. Foamix Ltd. is a privately held
company, whose business model is based on partnering with leading pharma and
cosmetics companies to develop products utilizing its proprietary foam technologies.
For additional information: www.foamix.co.il or Marjie Hadad, Media Liaison,
Foamix, Marjie@foamix.co.il; +972-54-536-5220.
To schedule an appointment with the Foamix management at the AAD 2006 in San
Diego please contact Foamix's US representative Mr. Charlie Harrison at
charlie@foamix.co.il or at (404) 229-1499.
|