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Strategic Science and Technologies Finalizes Phase 1 Clinical Trial for SST-6006

May 31, 2014

Strategic Science and Technologies, a clinical-stage biotechnology company developing topical formulations of known pharmaceutical products, announced the successful completion of its Phase 1 clinical trial of SST-6006, its topical sildenafil product candidate for treatment of men with erectile dysfunction.

The Phase 1 trial for the investigational drug was designed to assess the safety, tolerability and pharmacokinetics of SST-6006 in healthy men when applied topically directly to the entire penis. A cohort of subjects also received a single oral dose of sildenafil to allow for a comparison between SST-6006 and oral sildenafil.

"These promising results provide additional clinical validation of our Knosis platform and our ability to successfully deliver therapeutic doses of highly-charged molecules through the skin and into the target tissue," noted Eric T. Fossel, Ph.D., Scientific Founder and Chief Executive Officer of SST. "We look forward to initiating Phase 2 clinical trials this year to demonstrate the efficacy of SST-6006 in patients with the goal of commercializing a safe and effective topical OTC product for men with ED."

According to a release, SST-6006 was found to be well tolerated, with a significantly reduced number of side effects compared to oral sildenafil. All side effects were mild and transient in nature. The peak concentration of sildenafil detected in the blood after a single application of SST-6006 was more than twenty-fold lower than what was detected from a 50 mg oral dose of sildenafil. The presence of sildenafil in the blood from SST-6006 confirms successful delivery of sildenafil across the skin. SST intends to demonstrate in its development program that the very low systemic absorption of sildenafil from SST-6006 application, compared to oral sildenafil, will significantly reduce the side effects long associated with oral phosphodiesterase type-5 inhibitors. These data support SST's efforts to demonstrate that a single application of SST-6006 will deliver a concentration of sildenafil to the local target tissue (penis) that is equal to or greater than that delivered from a single 50 mg oral dose of sildenafil.

"With a growing concern about systemic side effects associated with the current oral forms of PDE-5 inhibitors, a topical treatment approach such as SST-6006 could enable patients with ED to benefit from a local therapeutic dose of sildenafil directly into the penile tissue while reducing the risk of unwanted systemic side effects," commented Irwin Goldstein, M.D., Director of Sexual Medicine at Alvarado Hospital and Director of San Diego Sexual Medicine. "I look forward to continuing my work with SST and its novel delivery technology to positively impact sexual health in both men and women."

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Source: Professional Services Close - Up

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