The broad, long-term goal of this research program is to develop a novel treatment for women with acromegaly: a sustained-release intravaginal ring (IVR) formulation for octreotide. Intramuscular sustained-release octreotide has been extensively studied and validated in the treatment of acromegaly. IVR delivery is a novel and theoretically feasible platform that can deliver peptides at clinically relevant levels. We believe that the potential of sustained-release IVR formulation is very underappreciated. More women use rings for contraception than implants or patches. 800,000 American women prefer rings to birth control pills. We have formulated intravaginal rings delivering a wide variety of small molecules, peptides, and proteins using our ?pod? technology . In preliminary work, we have formulated a pilot IVR, which releases octreotide in vitro over a 30-day period. For this Phase 1 SBIR application, we intend to further develop this ring to release an unprecedented 30-days sustained-release of octreotide in sheep, an FDA-preferred pre-clinical animal model for intravaginal delivery.
The specific aims of this Phase 1 proposal are to manufacture pre-clinical batches of octreotide IVRs; and to conduct a dose-escalation preclinical pharmacokinetics and toxicity study. The hypothesis of this study this project is that we can demonstrate clinically relevant plasma octreotide levels over a sustained period in the in vivo model. We propose a straightforward development plan to test this hypothesis that has readily measurable milestones. This proposal builds on Auritec Pharmaceuticals' successful technology platform and has a high probability of success. Subsequent clinical trials will establish the value of these IVRs as treatments for women with acromegaly.
The broad, long-term goal of this research program is to develop a novel treatment for women with acromegaly: a sustained release intravaginal ring (IVR) formulation for octreotide. In preliminary work we have formulated a pilot ring which releases octreotide over a 30-day period. The specific aims of this Phase 1 proposal are to manufacture pre-clinical batches of octreotide IVRs; and to conduct preclinical pharmacokinetics and toxicity studies. Subsequent clinical trials will establish the value of these rings as treatments for women with acromegaly.
