Agouron Pharmaceuticals Inc. said Monday interimresults from Phase II studies of Thymitaq (AG337),which is designed to block an enzyme needed for cancercell proliferation, showed positive effects against avariety of solid tumors.
Peter Johnson, president and CEO of La Jolla, Calif.-based Agouron, said that based on the data the companywill begin pivotal Phase II/III trials next year in head,neck and primary liver cancers. He added Agouronexpects to file a new drug application in those indicationsby the end of 1997.
Thymitaq, a synthetic chemical compound, is designed toinhibit thymidylate synthase. It is being evaluated as atreatment for six tumor types in six Phase II trialsinvolving about 14 patients in each study, all of whomreceived the drug. Responses of patients with head, neckand liver cancers appeared to be the most encouraging.
In the trials for head and neck cancers, four of the 14patients experienced a greater than 50 percent reductionin size of tumors and two patients had a 100 percentresponse. In six others, tumors were reduced or thedisease was stabilized.
Of the 13 patients enrolled in the liver cancer studies, oneexperienced a 70 percent reduction in tumor size and sixothers either had a less than 50 percent response or theirillnesses were stabilized.
The Phase II studies, which will be complete in the nextfew months, also tested Thymitaq in colon, lung,pancreatic and prostate cancers. For the 14 with cancer ofthe pancreas, two patients experienced less than 50percent reduction in tumors and the disease in 10 patientswas stabilized.
Among 37 other patients with cancers of the lung,prostate or colon, four experienced reductions in tumorsize of less than 50 percent and 32 saw their diseasestabilized.
Adverse events reported by Agouron were suppression ofbone marrow activity for a short time and mucositis.
The pivotal Phase II/III studies of the drug will involve800 to 1,000 cancer patients.
Agouron (NASDAQ:AGPH) closed Monday at $29.75,down 25 cents. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.