Oxigene Inc. announced Monday that it has received $2.3million from a private placement to fund Phase II/III clinicaltrials of its drug for use as an adjunct to radiation therapy intreating squamous cell lung carcinoma. The placement,representing approximately 30 percent of the New Yorkcompany's common stock, was sold to 30 individual investorsthrough Gilford Securities, also of New York.
The drug Sensimide, is Oxigene's formulation of the syntheticchemical compound metoclopramide, which has been in use formore than 20 years as an anti-emetic, primarily to preventnausea in chemotherapy patients. But Oxigene is using the drugbased on its ability to interfere with DNA repair. It inhibits thetumor DNA repair enzyme adenosine diphosphoribosyltransferase.
"Tumor cells are very efficient at DNA repair, using a differentmechanism than normal cells," explained John Lucas, thepresident and chief executive officer of privately held Oxigene."We've identified a whole series of compounds that inhibit thismechanism. One of them is metoclopramide."
Oxigene has a use patent on metoclopramide, to enhancechemotherapy, which has issued in the European Communityand in "several other areas" and which is pending in the U.S.,Lucas told BioWorld.
The drug has some undesirable side effects--including anxietyin some individuals and drowsiness--but Lucas says that thefirm has a second-generation molecule "that knocks thatout...We know what part of the molecule causes [the sideeffects]."
The Phase II/III clinical trials, which have been authorized byFDA, will be conducted in Sweden, on 200 patients at six sites,Lucas said. "The basic research has been done in Sweden andall product development has been done at Lund UniversityHospital."
In the pilot Phase I study on patients with squamous cell lungcarcinomaHalso done in SwedenHmetoclopramide used inconjunction with standard radiation therapy more thandoubled the mean longevity of patients receiving radiationaloneH277 days [as of Dec. 15] vs. 117 days.
"This is the worst kind of lung cancer, and the most resistant totreatment," Lund told BioWorld. "If we see efficacy [in thePhase II/IIIs] that compares with the pilot study we will askfor early approval," he said. "Under the terms of the IND, noU.S. trials will be necessary."
Lucas said that Oxigene also has been authorized by FDAHunder the same INDHto conduct trials on the drug for treatingpatients with glioblastoma, a brain tumor. "We'll probably start60 patients in the U.S. later this year for glioblastoma," headded.
-- Jennifer Van Brunt Senior Editor
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