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Preclinical development of an intravaginal ring for the sustained-release of octreotide for the treatment of acromegaly.

Award Number: R43HD090870
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2017
PERIOD OF PERFORMANCE END DATE: 08/31/2019

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Preclinical development of an intravaginal ring for the sustained-release of octreotide for the treatment of acromegaly. - PROJECT SUMMARY 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2020 ( Subtotal = -$1 )
2020	2017	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	1	12/19/2019	NEW	-$1
														Subtotal = -$1

Issue Date FY: 2017 ( Subtotal = $224,881 )
2017	2017	AURITEC PHARMACEUTICALS INC	3200 SANTA MONICA BLVD STE 201	SANTA MONICA	CA	90404	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	1	9/1/2017	NEW	$224,881
														Subtotal = $224,881

Grand Total All Awards = $224,880

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Preclinical development of an intravaginal ring for the sustained-release of octreotide for the treatment of acromegaly.

Award Number: R43HD090870

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2017

PERIOD OF PERFORMANCE END DATE: 08/31/2019

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