CellGate Announces Phase IIa Study Results of PsorBan(R) In the Treatment of Psoriasis
Friday May 2, 12:19 pm ET
Study Results Presented at Society for Investigative Dermatology Meeting
MIAMI BEACH, Fla., May 2 /PRNewswire/ -- CellGate, Inc., an emerging specialty pharmaceutical company creating novel medicines based on its proprietary transporter molecule technologies, has announced positive results from a randomized Phase IIa clinical trial for psoriasis with the company's topical cyclosporine conjugate, PsorBan® (CGC1072) ointment. Study results are being presented at the 64th Annual Meeting of the Society of Investigative Dermatology in Miami Beach, FL, by Alexa Kimball, M.D., MPH, Assistant Professor of Dermatology and Director, Clinical Trial Center, Department of Dermatology, Stanford University School of Medicine.
The double-blind placebo controlled trial evaluated safety and preliminary efficacy of two dose formulations (0.4% and 4.0%) of CellGate's proprietary topical cyclosporine conjugate ointment in 24 patients with mild to moderate plaque psoriasis. Subjects were randomized to receive one of the two strengths of the PsorBan® ointment and an internal control vehicle in self-applied treatments over six weeks. The study lesions were evaluated using the psoriasis severity score (PSS), color photograph and the physician treatment preference. High dose CGC1072 exhibited benefits over placebo in both PSS and physician preferences scores. In side-by-side comparisons of two concentrations of CGC1072 with a vehicle control, blinded investigators preferred the actively treated side over the control 80 percent of the time. Higher concentration of CGC1072 resulted in an improvement in psoriasis severity scores as early as day fourteen. In addition, cyclosporine levels in the skin and blood were measured periodically, and, importantly, PsorBan® ointment was able to show active drug tissue level in the same therapeutic range as oral cyclosporine in the skin, but blood levels of the drug were undetectable among the participants in the study. There were no serious adverse events.
"Data from this small pilot study suggests that CellGate's topically applied cyclosporine conjugate product, PsorBan®, may improve psoriasis," said Dr. Kimball, a lead investigator on the study. "This novel topical treatment appears to be well tolerated, not absorbed systemically, and offers potential benefit in treating mild to moderate psoriatic patients without the associated systemic adverse effects typically associated with cyclosporine."
"We are very pleased by the consistent performance of our lead product," said Edward F. Schnipper, M.D., CellGate's President and Chief Executive Officer. "We believe CellGate's PsorBan® product represents an important innovation for providing the millions of patients suffering from mild to moderate psoriasis with a potentially safe, convenient and effective first-line therapy. We are looking forward to the results of our ongoing Phase IIb multi-center clinical study of PsorBan® in psoriasis later this year, as well as to the continued advancement into the clinic of our pipeline of novel medicines based on our transporter molecule technologies."
PsorBan® Topical Cyclosporine -- An Ideal Drug Candidate for Psoriasis
CellGate has chemically transformed cyclosporine to increase absorption into tissues and cells using the company's proprietary molecular transporter technologies.
While oral administration of cyclosporine has long proven effective as a treatment for psoriasis, organ toxicity limits its use systemically, and the drug has shown poor absorption when applied topically.
CellGate's PsorBan® product has been designed to leverage cyclosporine's efficacy while reducing toxicities when applied locally at the site of disease -- creating a highly safe topical ointment suitable for direct application to the chronic plaques that characterize psoriasis.
In Phase I clinical studies of healthy volunteers, CellGate has demonstrated that its PsorBan® product penetrates skin and retains biological activity. A multi-center Phase II registration study of PsorBan® topical cyclosporine conjugate ointment is currently underway.
About Psoriasis
Psoriasis is a non-contagious, chronic skin condition affecting as many as five million people in the United States, with approximately 150,000 new cases diagnosed per year. Psoriasis is believed to be a disorder of the immune system in which T cells (a type of white blood cell) in the skin trigger inflammation and excessive skin cell reproduction. The condition is characterized by flare-ups which may be caused by changes in climate, infections, certain medicines, stress and dry skin. Approximately two-thirds of the psoriasis patient population suffers from mild to moderate disease with few effective treatment options.
About CellGate
CellGate, Inc. is an emerging pharmaceutical company developing novel medicines by chemically combining proprietary transporter molecules with clinically proven compounds and promising drug candidates in order to improve their therapeutic value. The company's proprietary transporter technology enhances drug performance by allowing medicines to penetrate through biological barriers for more efficient cell entry. CellGate's unique technologies are applicable to a broad range of molecules and may be tailored to suit diverse therapeutic indications. Initially, CellGate is focusing its efforts in the areas of dermatology, with a lead drug candidate for psoriasis, PsorBan®, currently in clinical studies. In addition, multiple product candidates addressing key therapeutic areas, such as oncology and ophthalmology, are in pre-clinical evaluation. The company is developing products for its own marketing and concurrently pursuing strategic partnerships to support valuable new therapeutics. Founded in 1998 and headquartered in Sunnyvale, California, CellGate is privately held. For more information about the company, please refer to the company's website at www.cellgateinc.com.
Source: CellGate, Inc.
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