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Texas A&M biologist James Smith's outstretched hand holds a petri dish containing a fungal specimen
Image: Courtesy Photo

Texas A&M University startup Sano Chemicals has announced a major milestone for the first of its innovative drug products, OCF001, which has been approved by the U.S. Food and Drug Administration (FDA) for testing in humans in a Phase 1 clinical trial.

OCF001 is a formulated drug product containing occidiofungin and is being studied as an effective treatment for recurrent vulvovaginal candidiasis (RVVC). Occidiofungin is a potent broad spectrum fungicidal compound that Sano Chemicals is developing into a new treatment for drug-resistant fungal infections, for which there are no effective treatments currently available.

Dr. James Smith, a professor in the Department of Biology, began working on occidiofungin almost 15 years ago after discovering it in collaboration with Dr. Shien Lu and Dr. Frank Austin, professors at Mississippi State University, which led to the formation of Sano Chemicals.

“There are only a handful of new antifungal drug products in clinical trials and many of these belong to an existing class of antifungals,” Smith said. “Occidiofungin is a first-in-class antifungal and is effective against antimicrobial resistant fungi. FDA approval for Phase 1 clinical studies is very exciting and would not be possible without all the hard work from those at Sano Chemicals or the cooperation of The Texas A&M University System.”

RVVC, or chronic yeast infection, is defined as three or more confirmed infections over a one-year period and occurs in up to 10% of women. A successful new drug could lead to widespread impacts.

“OCF001 has the potential to improve the quality of life for millions of women with RVVC," Smith said. "The impact of RVVC on the physical and emotional quality of life is overlooked and has serious debilitating effects on the health of those with the medical condition."

According to Smith, the FDA has also granted Sano Chemicals the Qualified Infectious Disease Product (QIDP) and Fast Track designations, which are only given to antimicrobial products that have potential to treat serious unmet medical conditions.

Occidiofungin shows great promise in treating the millions of people each year who are affected by severe fungal infections caused by drug resistant fungi. Smith says Sano Chemicals will continue to develop new drug products using occidiofungin for the treatment of dermal, oral and invasive fungal infections.

Read a past feature on Smith and Sano Chemicals, courtesy of Texas A&M Innovation.

This story was originally published by Texas A&M Innovation.

About Texas A&M Innovation

Texas A&M Innovation at College Station works with a diverse array of partners (including entrepreneurs, investors, technology incubators and large enterprises) to improve lives by commercializing innovations from The Texas A&M University System. Texas A&M research generates more than 300 new technologies each year, providing abundant and varied opportunities for industry collaboration. Learn more about the Texas A&M Innovation technology portfolio.