NEW YORK -- Oxigene Inc. is hoping that an investigational newdrug (IND) application, expanded clinical trials in Sweden andan agreement with a major company will help put somestuffing into its thin cash cushion.
Oxigene plans to file in September an IND application with theFDA to try its DNA-repair blocker in humans. The company isalso sponsoring expanded clinical trials in Sweden of itsproprietary enzyme-inhibitor to enhance the efficacy ofradiation therapy for lung cancer patients
"In about 18 months," John E. Lucas, Oxigene's president andchief executive, told BioWorld, "we hope to go back to FDA witha new drug application (NDA) to market this compound in theUnited States."
It's a tall order for a company with just $800,000 in cash and amonthly burn rate of $150,000.
To fund the clinicals, Oxigene two weeks ago turned to "a fewventure capitalists and private investors for a placement of$1.5 million," Lucas said. Individual subscribers had alreadyput up $500,000, he added.
With just under $800,000 in cash and equity, plus the proceedsof this current $1.5 million offering, the company can fundoperations through the first quarter of 1993, accordingOxigene's private placement prospectus.
Oxigene said it hopes then to raise additional funds at a highervaluation, based on the IND filing, clinical trials and at leastsubstantial progress toward an agreement with a majorcorporate partner. Oxigene's goal is liquidity through an IPO atthe earliest practicable date.
Oxigene has applied for patents on various aspects of its R&Dworldwide, but so far has been granted just one patent inCanada. In 1987 the company filed for a U.S. patent for itstumor-killing technology and revised it on June 10, 1992.
Oxigene acquired its core DNA-repair technology and itsresearch director, Ronald W. Pero, from the Strang CancerPrevention Clinic of New York in 1988. Pero now commutes tothe University of Lund, Sweden, whose teaching hospitalmounted the Phase I clinical trial of Oxigene's tumor-fightingcompound.
"We are probably the first DNA-repair company to come downthe pike," Pero told BioWorld.
The tumor-fighting compound is based on a drug calledmetoclopramide, which physicians already prescribe as an anti-nauseant. Besides calming the queasiness of rough seas andearly pregnancy, Pero told BioWorld, metoclopramidesuppresses the severe nausea of anti-cancer drugs.
Pero and his research associates discovered thatmetoclopramide also acts to inhibit one of the key enzymesthat repair damaged DNA in genes.
At Lund Hospital, physicians believe that metoclopramidetreatment extended the lives of eight patients with advanced,inoperable lung cancer. They were receiving gamma-radiationto decimate the DNA in their tumor cells and had a lifeexpectancy of six months. After intravenous infusions ofmetoclopramide 30 minutes before alternate X-ray sessions forsix weeks, all survived at least eight months, and four are stillalive.
The trial will now be expanded to Sweden's entire populationof squamous-cell pulmonary carcinoma cases. This large-scale,Oxigene-supported study is planned to start in October andenroll 180 patients. "Doing it in Sweden might cost us $1.5million," Lucas said. "If we ran it in the U.S., the cost would be$4.5 million."
An independent clinical trial organization, Cato Research Ltd. ofDurham, N.C., will preview the results of the Swedish studyafter the first 60 participants have been treated, about four tosix months along. According to Oxigene's prospectus, "If thedata is statistically significant with regard to efficacy at thistime, then the study may be scaled down or stopped and finalFDA approval sought immediately."
-- David N. Leff Science Editor
(c) 1997 American Health Consultants. All rights reserved.