THE COMPLEX 4-CARBOXYPHTHALATO (1, 2-DIAMINOCYCLOHEXANE) PLATINUM (NSC 271674; DACH-PT) HAS UNDERGONE LIMITED CLINICAL TRIALS.

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 4722
Amount: $50,000.00
Phase: Phase I
Program: SBIR
Awards Year: 1986
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
7315 Wisconsin Ave, 650n, Bethesda, MD, 20814
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 PETER ANDRULIS JR
 PRINCIPAL INVESTIGATOR
 (301) 657-1700
Business Contact
Phone: () -
Research Institution
N/A
Abstract
THE COMPLEX 4-CARBOXYPHTHALATO (1, 2-DIAMINOCYCLOHEXANE) PLATINUM (NSC 271674; DACH-PT) HAS UNDERGONE LIMITED CLINICAL TRIALS. DESIGNED AS AN ALTERNATIVE THERAPY TO CISPLATIN, IT HAS DEMONSTRATED SUBSTANTIALLY REDUCED TOXICITY AND ENHANCED ACTIVITY IN TUMORS RESISTANT TO CISPLATIN IN ANIMALS STUDIES, RESULTS CONFIRMED IN THE CLINIC. HEAVILY PRETREATED PHASE I AND PHASE II PATIENTS RESPONDING TO DACH-PT THERAPY INCLUDED THOSE WITH LUNG, NASOPHARYNGEAL, GASTRIC, OVARIAN, AND BLADDER CANCERS. RENAL AND GASTROINTESTINAL TOXICITY, THE MAJOR SIDE EFFECTS OF CISPLATIN, WERE MINIMAL. EVEN THOUGH THIS COMPLEX POSSESSES OUTSTANDING THERAPEUTIC PROPERTIES, DIFFICULTIES IN PURIFICATION AND AN INHERENT INSTABILITY, RESULTING IN HYDROLYTIC DISSOCIATION, HAVE VIRTUALLY HALTED FURTHER CLINICAL EVALUATIONS ESSENTIAL FOR ITS DEVELOPMENT INTO A COMMERCIALLY AVAILABLE ANTICANCER DRUG. ALL PURIFICATION PROBLEMS HAVE BEEN SOLVED AND BULK QUANTITIES OF THE DRUG HAVE BEEN PREPARED TO ANALYTICAL SPECIFICATIONS FOR CLINICALUSE. IT IS NOW PROPOSED TO ATTEMPT TO STABILIZE THE DRUG BYVARYING TEMPERATURE, PH, BUFFER CONCENTRATION, ETC., IN AN EFFORT TO OBTAIN THE OPTIMUM CONDITIONS IN WHICH THE COMPLEXWILL HAVE ACCEPTABLE STABILITY CHARACTERISTICS WHILE RETAINING ITS SUPERIOR THERAPEUTIC PROPERTIES. SUCCESSFUL STABILIZATION OF DACH-PT SUFFICIENT FOR FORMULATION WILL LEAD TO A DRUG PRODUCT WITH VERY STRONG COMMERCIAL POTENTIAL.

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

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