Cytel Corp. said Monday it has filed an investigational new drug(IND) application to start clinical trials of its first drug -- anovel monoclonal antibody for treating systemic inflammatoryresponse syndrome, or SIRS.
SIRS, a recently described clinical term, is associated withtissue injury and trauma that results from potentially life-threatening diseases, such as septic shock. It is characterizedby several potentially fatal symptoms, including fever,increased heart rate and hypotension. SIRS involves a cascadeof critical inflammatory events that trigger white blood cellmigration from the bloodstream through the endothelial cellslining the blood vessels and into the affected tissue.
Cytel's CY-1787 MAb has been shown in preclinical studies toblock a specific endothelial cell receptor, which belongs to aclass of cell adhesion molecules known as selectins.
"We believe CY-1787 will represent the first selectin blocker ofany kind to reach the clinic," said Jay D. Kranzler, president andchief executive officer of the La Jolla, Calif., company.
The prospectus for Cytel's 1991 initial public offering set as onegoal taking at least one potential drug into clinical trials during1992. "We'll certainly have one, and by the end of the year Ihope to have two or three," Kranzler said. Within 12 months,Cytel aims to have five potential drugs in clinical trials, he said.
Among the candidates for clinical trials are CY-1503, which isalso targeted at acute inflammation and reperfusion injuries;and CY 1747 to treat acute inflammation and reperfusioninjuries, such as myocardial infarction or transplantation.
Cytel has exclusive marketing rights to CY-1787 for the U.S.and Europe. "We'll always consider partners, but we're notactively seeking partners at the moment," Kranzler said. Thecompany had about $40 million in cash as of June 30, enough tofund slightly more than two more years of operations, he said."Sometime in the next two years, obviously, we'll need to raisemoney."
The Phase I clinical study of CY-1787 is to be conducted atRush University Medical School in Chicago. Besides safety andtoxicity, the Phase I study is designed to help the companydetermine the disease target for Phase II clinicals, Kranzlersaid.
Because of CY-1787's far-reaching potential to block thepassage of white blood cells, "to a certain extent, it's arbitrarywhich disease you pick," he said. Lung infection, skininflammation and sepsis are the initial targets beingconsidering.
Sumitomo Pharmaceuticals Co. Ltd. of Japan has an optionthrough early autumn to license exclusive marketing rights toCY-1787 for Pacific Rim markets, including Japan and Australia.Cytel would manufacture the product and receive undisclosedmilestone payments and royalties on the product sales,Kranzler said. "My guess is that they'll exercise the option."
-- Ray Potter Senior Editor
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