BALTIMORE -- Cytel Corp. is about to begin Phase I trials withits first injectable vaccine, CY1899, for hepatitis B, Jay Kranzler,the company's president and chief executive officer, saidWednesday at the Alex. Brown & Sons 18th Annual Health CareSeminar here.
FDA has approved the investigational new drug application(IND) the company filed in December, and Cytel has beenworking out formulation issues, Wendy Johnson, director ofbusiness development, told BioWorld.
The La Jolla, Calif., company (NASDAQ:CYTL) also hopes totarget HIV, hepatitis C, cancers of the cervix and prostate, andmalignant melanoma. "By the end of 1993, it is likely we willbegin one of the cancer therapy trials," Deborah Goode, Cytel'sassociate director of finance, told BioWorld.
Any cancer cell and any virus-containing cell may presentseveral thousand antigens, and some of them draw cytotoxic Tcells better than others. Finding the best antigen would requirescreening about 3,000 peptides -- years of work, Kranzlerexplained.
Cytel's strategy is to use its proprietary algorithms to screenpeptides, reducing the number of candidates to 200-300. Invitro assays then weed out all but 15 or so, and ex vivo and invivo assays pick the winner. All this takes just weeks, Kranzlersaid.
"Within 12 months, these can be formulated and developedinto drug candidates," said Goode. The selected antigens primethe cytotoxic T cells to home in on their target cells.
"The question is, does the technology really work?" Goodequeried, and will the T cells be capable of seeking out the cellsthey are programmed to destroy? Animal studiesdemonstrated success, but for humans, "that's only to be seenin the clinic," said Goode.
"There are so many things we can do," said Kranzler. "The onlyreal constraint is resources."
"We have $50 million -- not a lot of money," he said. "The burnrate is $20-$25 million. I'm committed to make sure the moneyin the bank lasts us to the end of 1995, which is somewhatarbitrary, but based on how long we believe it will take for allthe things we have in the hopper to get into Phase II," Kranzlersaid. "Ultimately, that should determine success or failure."
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.