British Biotech plc completed a safety study of its Stem CellChemokine in healthy volunteers and has begun a study in cancerpatients, the Oxford, England, company said Monday.The drug, BB-10010, now is going into a Phase I/II trial in ninecancer patients in the U.K. that will build on the initial study in termsof safety and pharmocokinetics, as well as looking for a comparablemobilization of blood cells into peripheral blood, Gary Patou, thecompany's deputy director of clinical research, told BioWorld."The volunteer study has gone extremely well, beyondexpectations," Patou said. "It gave us some clear indications ofmobilization of mature cells from bone marrow comparable to thatseen in animals." The goal would be to harvest stem cells from thebloodstream before chemotherapy and replace then after treatment,potentially replacing bone marrow transplantation.In addition to mobilization, British Biotech also is assessing the drugas a protector of stem cells during chemotherapy. Its intended effectis delaying the cells from dividing, making them less sensitive tochemotherapy. Therefore, Patou said, the drug could reduce someside effects of chemotherapy while allowing for higher doses.Patou said the company is developing a Phase II program to studyboth the protection and mobilization endpoints. "We envisage a 30-patient protection study in the U.S. in the first quarter of 1995, and aPhase II mobilization study in the U.K." in a similar time period, hesaid, adding a European protection trial also is slated for 1995. Theinitial study showed that BB-10010 was tolerated at all doses, andthat subcutaneous administration is preferable to intravenousdelivery.British Biotech's stock (NASDAQ:BBIOY) was up $1.50 per shareMonday, closing at $20 per share. _ Jim Shrine
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