Introgen Therapeutics Inc., a gene therapy company in Austin,Texas, has entered into a collaboration to develop cancer treatmentswith Rhone-Poulenc Rorer Inc. that could pay the privately-heldbiotechnology firm as much as $50 million over the next severalyears.The agreement, announced Thursday, is based on development ofIntrogen's gene therapy involving p53 genes and K-ras oncogenes.It's the second big pharmaceutical-biotechnology deal in as manydays involving p53-related technology for cancer drugs. (For anoverview of recent big pharmaceutical company collaborations in thearea of gene therapy, see next Monday's issue of BioWorld FinancialWatch.)Schering-Plough Corp., of Madison, N.J., signed an agreementWednesday with San Diego-based Canji Inc. for development of itsp53 gene therapy. The companies said that deal also could be worthas much as $50 million to Canji over the next several years. (SeeBioWorld Today, Oct. 27, 1994, p. 1.)The p53 gene is considered a tumor suppressor, which when healthyis believed to prevent abnormal cell growth. Defective p53 geneshave been associated with half of all cancers worldwide. BothIntrogen and Canji have developed technologies for deliveringhealthy p53 genes to tumors in an effort to restore normal cellgrowth and induce cancer cells to self-destruct.Among the differences between the Introgen-Rhone-Poulenc andCanji-Schering-Plough deals is that Introgen apparently is closer tobeginning clinical trials than Canji. However, assuming all trialsconducted by both Introgen and Canji were successful, a marketableproduct still is at least four or five years away.Introgen's president, David Nance, told BioWorld the companyexpects to begin two clinical trials of p53 gene therapy for treatmentof non-small cell lung cancer by the end of this year. The studies willinvolve treatments with p53 genes delivered by a retroviral vector inone trial and an adenoviral vector in the other.Canji expects to begin its first clinical trial with p53 gene therapy inthe second half of 1995. The study will target liver cancer and use anadenoviral vector to deliver the p53 gene.Nance said Introgen also has approval from the RecombinantAdvisory Committee of the National Institutes of Health to conducttwo other clinical trials involving p53 gene therapy for lung cancer.The commitments by Rhone-Poulenc and Schering-Plough indicate avalidation of the p53 approach to fighting cancer, Nance suggested.More Collaborations In The WorksAnd, he said, "It's not inconceivable that we could have someinteraction with Canji in the future. We have other parallelprograms."The agreement between Introgen and Rhone-Poulenc, ofCollegeville, Pa., also involves development of a K-ras oncogeneinhibitor.K-ras oncogenes, which are normally inactive, have been foundactivated in some tumors and are believed to spur rapid cell growth.Introgen, Nance said, has developed a gene therapy designed toblock the oncogene.Financial details of the Introgen-Rhone-Poulenc deal were notdisclosed. Nance said the initial contract extends through 1997. Theagreement gives Rhone-Poulenc a "minor" equity position inIntrogen, Nance said.Rhone-Poulenc's spokesman, Bob Pearson, said the up-front cashand potential development milestone payments could be worth up to$50 million for Introgen.Under the agreement, Rhone-Poulenc will fund the research anddevelopment worldwide and will get rights to manufacture andcommercialize products in Europe. Introgen and Rhone-Poulenc willhave co-promotion rights in North America, Japan, Korea, India,China and Australia. Introgen, which has laboratories in Houston,retains manufacturing rights in North America.In addition to targeting lung cancer, the Introgen-Rhone-Poulenccollaboration also will focus on treatments for brain, cervical,colorectal and head and neck cancers.Introgen was formed in 1993 by Austin-based Texas BiomedicalDevelopment Partners, which was founded to commercializetechnologies invented by researchers at the University of Texas.Introgen's product development is based on the gene therapymethods of Jack Roth, chairman of the department of thoracic andcardiovascular surgery at the university's M.D. Anderson CancerCenter in Houston.Texas Biomedical Development Partners is composed of E.J.Financial Enterprises Inc., of Chicago, and Domecq TechnologiesInc. and the Texas Medical Research Foundation, both of Austin.Rhone-Poulenc's investment in Introgen is not the drug company'sfirst association with gene therapy. Pearson said it also hasagreements with Applied Immune Sciences Inc., of Santa Clara,Calif., and Darwin Molecular Corp., of Bothell, Wash. n

-- Charles Craig

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