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TAS::75 0849::TAS TOPIC 255: A TARGETED DRUG FOR NON-MUSCLE INVASIVE BLADDER CANCER

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: N43CO110094
Agency Tracking Number: N43CO110094
Amount: $176,266.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: N/A
Timeline
Solicitation Year: 2011
Award Year: 2011
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
119 UPSHIRE CIR
GAITHERSBURG, MD 20878-5215
United States
DUNS: 831413419
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 GRAHAM ALLAWAY
 (301) 452-6452
 GALLAWAY@CELEKPHARMA.COM
Business Contact
 GRAHAM ALLAWAY
Phone: (301) 452-6452
Email: GALLAWAY@CELEKPHARMA.COM
Research Institution
 Stub
Abstract

CEL-031 is being developed as a novel, targeted tre8tment for non-mLiscle invasive bladder cancer (NMIBC). Bladder cancer is the 5th most common cancer in the US, with most cases diagnosed 8t the nonmuscle invasive stage. It is the most expensive cancerto treDt on a per patient basis. There is 8 significant need for more effective and less toxic therapies for NMIBC. CEl-03'1 8Cts through a novelmech()nism of action to selectively kill bladder cancer cells. It does tl1is by targeting certain enzymes that are overexpressed in these cells. In clinical trials, CEl-03'1 WDS well tolemted with preJiminmy evidence of effic8cy 8gainst advanced cancers. However, efficacy was limited by poor ora! bioavailnbi lity. CEl-031 should demonstrate greater efficacy against NI\l1IBC, since it ViiI! be delivered by bladder instillation, thereby minimizing drug metabolism nnd protein binding issues. This project will investigate the effect of CEl-03" on bladder tumor cells and test for potential synergy in combination\Nith oUler drugs. A liquid formulation will be developed, which will be used to test CEl-031's efficacy in 8 mouse bladder C8ncer model. If these studies are sllccessful, a proof-of-concept clinical study of CEl-03'! in NMIBC patients viill be initiatedduring the Phase II SBIR project

* Information listed above is at the time of submission. *

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