Cell Therapeutics Inc. (CTI), a privately held Seattlebiotechnology company, announced today that it will initiatefour multicenter Phase I clinical trials on its drug therapyProTec (CT-1501R) for limiting the toxic side effects of cancertreatments, including radiation, chemotherapy and interleukin-2 (IL-2) therapy.

The trials will focus on patients undergoing bone marrowtransplants from genetically related donors for treatingadvanced blood cell cancers, patients receiving bone marrowtransplants from genetically unrelated donors, patients withadvanced breast cancer receiving high doses of chemotherapy,and patients with advanced renal cell cancer or melanoma whohave failed conventional chemotherapy and are being treatedwith IL-2.

CTI's drug CT-1501R is a second-generation product. Itsprecursor, CT-1500 is a combination of pentoxifylline (a drugfor vascular diseases) and ciprofloxacin (a broad-spectrumquinoline antibiotic). In the clinic, CT-1500 significantlydecreased the major toxicities of IL-2/lymphokine activatedkiller cell therapy, thus making it possible to administer moreIL-2, according to the results of Phase I trials in renal cellcancer patients presented Monday at the American Society ofClinical Oncology Annual Meeting in Orlando, Fla.

And CTI also has completed a Phase II trial in 75 high-riskcancer patients of CT-1500, in which the compound provedequivalent to granulocyte macrophage-colony stimulatingfactor and granulocyte-colony stimulating factor in promotingthe recovery of white blood cells and superior to them inpromoting the recovery of platelets and red blood cellsfollowing high-dose chemotherapy.

As for the second-generation product, "In mouse studies,administration of CT-1501R with high doses of chemotherapysignificantly lessened platelet nadir, significantly acceleratedneutrophil, platelet and multi-lineage hematopoietic progenitorcells and protected against non-hematopoietic toxicity,"according to James Bianco, CTI's president and chief executiveofficer. "We are encouraged about its potential as an adjunctivetherapy in the treatment of cancers."

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