Posted On: 03/19/2012 3:05:56 PM
Post# of 212
Clinical Development Path
The early stage preclinical studies for our lead compound, Adva-27a, were successfully completed in late 2011. We are now continuing our clinical development program of Adva-27a by conducting the next sequence of steps comprised of the following:
| • | GMP Manufacturing (for use in IND-Enabling Studies and Phase I Clinical Trials) |
| • | IND-Enabling Studies |
| • | Regulatory Filing (Fast-Track Status Anticipated) |
| • | Phase I Clinical Trials (Multidrug Resistant Breast Cancer Indication) |
Clinical Trials
Adva-27a’s initial indication will be multidrug resistant breast cancer for which there are little or no treatment options. In June 2011 we concluded an agreement with McGill University’s Jewish General Hospital in Montreal, Canada to conduct Phase I clinical trials for this indication. All aspects of the planned clinical trials in Canada will employ FDA standards at all levels. We anticipate that the clinical trials will be completed by late 2014, at which time we, together with our licensor, expect to file for limited marketing approval with the regulatory authorities in Canada and the FDA in the U.S. See “Marketing,” below.
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