Ilex Oncology Inc. is a lot further along than most start-upcompanies.
The spin-off from the San Antonio-based Cancer Therapy &Research Center (CTRC) already has three products in late-stagetesting for cancer indications, and may file its first new drugapplication in 1995. In addition, its contract work already is bringingin about $1 million per quarter.
"We have a unique concept of acquiring compounds in late stages ofdevelopment and using the expertise here in San Antonio for clinicalresearch and development," said Richard Love, Ilex's president andCEO.
"The physicians here identify the leads, compounds they personallyknow are active," he told BioWorld. Then Ilex personnel researchthe drug, looking for results of previous studies, identifying thepatent holder and determining if it is a suitable candidate for the Ilexportfolio.
"Our focus is oncology, anything that would work for a patient withcancer," Love said. "It's focused on anti-cancer drugs, ondevelopment rather than discovery."
The CTRC, a non-profit outpatient cancer treatment and researchorganization, holds a majority of Ilex's stock. Love said some stockwill be sold to private investors in the next few months, and Ilex hashired Vector Securities International Inc., of Deerfield, Ill., tofacilitate the capitalization of the company. Ilex was formed as a for-profit entity on Oct. 1 when CTRC transferred its advanceddevelopment and manufacturing programs to its spin-off.
The company's products in the clinic are mitoguazone (MGBG),cristanol mesylate and dihydro-5-azacytidine (DHAC).
MGBG, a synthetic small molecule, inhibits synthesis of polyamines,which are chemicals used by dividing cells. The product is in PhaseII pivotal testing at 17 centers for AIDS-associated lymphoma inpatients refractory to conventional therapy.
MGBG is delivered by intravenous infusion once a week for the firstweek, then every other week as long as there is beneficial response.Published reports of the drug in lymphoma patients show objectiveresponses of anywhere from 28 to 45 percent, Love said.
"The plan will be to move this drug forward into a front-linetreatment regimen combined with other drugs used to treatlymphoma," Love said. Ilex expects to file for marketing approval inlate 1995. Marketing rights have been licensed to Sanofi WinthropPharmaceuticals, of New York, a subsidiary of Paris-based Sanofi-Chimie.
"For all the agents we take forward, we'll want to have a partner,"Love said.
Ilex has organized Phase III trials at 16 centers comparing cristanolto BCNU, the only approved drug for glioblastoma multiforme, anaggressive form of brain tumor. Cristanol interacts with DNA andblocks replication of DNA in dividing cells. The randomized trial isexpected to enroll about 200 patients, with endpoints of time todisease progression and overall survival.
Sanofi also has marketing rights to that synthetic small molecule.Love said the agreements with Sanofi involve development funding,milestone payments and royalties.
The third drug, DHAC, interacts with DNA, causing cells todifferentiate. The compound, which has been in Phase I and IIstudies, has shown activity in mesothelioma, a cancer of the pleurasurrounding the lungs that often is caused by exposure to asbestos. Apivotal Phase III study of DHAC comparing it in combination withand against hematopoietic growth factors is expected in 1995, Lovesaid. The indication will be myelodysplastic syndrome, a pre-leukemia condition. Ilex still owns rights to DHAC.
Ilex chose to announce its formation last week, when it received a$1.5 million award from the federal Economic DevelopmentAdministration to help construction of a good manufacturingpractices (GMP) facility for the manufacture of chemotherapy drugs.
The company already has revenue from a few contracts, and Loveexpects even more as the GMP facility comes on line in the thirdquarter of 1995.
Some of the Ilex's technology and drugs were developed at theUniversity of Texas Health Science Center at San Antonio, whichcooperates with the CTRC in cancer research and treatment. Lovesaid Ilex plans a private placement early in 1995, and perhaps aseries of placements before eventually going "public when themarket and our business is right for that." n
-- Jim Shrine
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