Auritec completes first clinical trial on an intravaginal ring for the treatment of genital herpes.
Santa Monica, CA. April 1, 2011
Auritec Pharmaceuticals, Inc. is pleased to announce the completion of its first clinical trial, a pre-Phase 1 trial for a preliminary assessment of the safety of an intravaginal ring (IVR) releasing acyclovir for the treatment of genital herpes. All the women in the trial were currently on oral valacyclovir which they stopped during the duration of the trial. Three women wore the ring for 3 days and 3 women wore the ring for 7 days. The rings were well tolerated with no adverse events reported. Vaginal lavage and plasma samples were collected 12-18 h after the last oral dose, and then 1, 3, and 7 days following placement of the IVR and analyzed for drug levels (ABC Labs Columbia, MO). Notably, the levels of ACV detected in vaginal lavage were at least as great as what was detected in women while on oral valacyclovir. Moreover, little or no drug was detected in the plasma, consistent with the lack of systemic absorption. Moving forward, larger studies will be done to further elucidate the IVRs safety and efficacy in the treatment of genital herpes. Auritec is excited with the positive outcome for its first clinical program in woman’s health.
About Auritec Pharmaceuticals
Auritec Pharmaceuticals, Inc. based in Santa Monica and Pasadena, CA, is a R&D company specializing in innovative, extended release drug delivery systems. Auritec was founded by Thomas J. Smith, MD, who has been granted 9 INDs and 2 NDAs throughout his pharmaceutical career in sustained release drug delivery. Dr Smith is joined on Auritec's management team by Gary Ransom, a seasoned international business executive, who focuses on strategy, marketing and business development.
Auritec’s Plexis™ technology is an innovative, polymer-based, proprietary platform technology for sustained release of drugs given by injection. Plexis™ combines a membrane based, diffusion-driven release mechanism with drug particle sizing large enough to allow high drug loading, but small enough to be injected. Plexis™ combines the benefits of linearization of release with those of injectability.
Auritec’s Versa™ technology is an implantable drug delivery platform that is responsible for two FDA approved products. It is based on a core of solid drug, coated with a semi-permeable polymer.
Auritec has developed a novel approach to extended release drug delivery with implications so far for indications including schizophrenia, Parkinson’s Disease, arthritis, herpes and HIV/AIDS. Auritec’s primary objective is to develop and test the use of its Plexis and Versa platforms in a wide range of drug classes, and subsequently license the technology to key partners to continue development, trials and eventual commercialization. Auritec has been previously funded by numerous NIH grants and their IP estate includes worldwide granted and pending patents.