FLEXIBLE SYSTEM TO ADVANCE INNOVATIVE RESEARCH
FOR CANCER DRUG DISCOVERY BY SMALL BUSINESSES (FLAIR)
This initiative provides a flexible system within the SBIR and STTR programs to accommodate the extensive needs of the complex drug and vaccine discovery and development process, at least partially, from basic discovery through proof of principle demonstration in clinical trial. The term "drug" is broadly defined to include any agent useful for the treatment or prevention of cancer.
FLAIR was first issued as a Request for Application (RFA), CA-98-022, with two application receipt dates. It was published in the NIH Guide, release date, August 20, 1998. The initiative has been reissued three times, as a Program Announcement (PA) PAR-00-030, release date, December 15, 1999, with two application receipt dates, with PA-01-091, release date, May 7, 2001, with three application receipt dates and just recently with PAR-03-074, release date, February 25, 2003, with two applications receipt dates extending to November 14, 2003.
AWARDS: RFA 98-022
FLAIR First Round (8 awards)
FLAIR Second Round (8 awards)
AWARDS: PAR 00-030
FLAIR Third Round (11 awards)
FLAIR Fourth Round (6 awards)
AWARDS: PA 01-091
FLAIR Fifth Round (17 Awards)
FLAIR Sixth Round (11 Awards)
FLAIR Seventh Round (14 Awards)
FLAIR Eighth Round (14 Awards)
FLAIR Ninth Round (10 Awards)
Investigational New Agents:
| Agent | Major Accomplishment: |
| A-007 | DEKK-TEC, Inc., is evaluating A-007, a novel phenylhydrazone, as an immune modulator in anogenital cancers associated with HPV. A-007 has completed a Phase I study (SBIR) in advanced cancers spread to the skin with minimal toxicity and objective responses. In a Phase 2 trail (FLAIR), anogenital cancers are responding to A-007 with complete responses - eliminating the need for aggressive surgery. Studies are being conducted in New Orleans and Baltimore under an Investigational New Drug. Application approved by the FDA. |
| PX-12 | PROLX Pharmaceuticals Corporation has started a Phase I clinical trial to study the safety of a novel thioredoxin inhibitor, PX-12, a small molecule designed to block the growth of cancers. Thioredoxin, which is abnormally high in many cancers, is involved in the control of many cellular factors that promote cell growth through a redox regulation process. Studies will be conducted at the University of Pittsburgh Cancer Institute and the Arizona Cancer Center in Tucson, AZ under an investigational New Drug Application approved by the FDA in July 200l. |
| Ad-mda7 | Introgen Therapeutics, Inc., is evaluating Ad-mda7, an adenovirus with melanoma differentiation associated gene7, a new tumor suppressor gene. Phase I studies supported construct optimization and proof of principle efficacy. In Phase II safety testing, IND filing and clinical trial development were conducted. Currently, melanoma cancer patients are accruing for Phase I clinical trials. |
FREQUENTLY ASKED QUESTION ABOUT FLAIR
Q: Is FLAIR currently active?
A: No. Its future is under discussion at this time.
Contacts:
Dr. George S. Johnson
Grants & Contracts Operations Branch, DTP, DCTD
National Cancer Institute
6130 EXEC BLVD RM 8153 MSC 7456
BETHESDA MD 20892-7456
johnsong@exchange.nih.gov
Telephone: (301) 496-8783
Fax: (301) 402-5200