Chemokine Therapeutics Corp. announces positive preliminary data

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Chemokine Therapeutics Corp. announces positive preliminary data and the successful completion of the dose-escalation portion of its Phase Ib/II clinical trial for CTCE-9908, the company's anti-cancer drug candidate. No dose limiting toxicities were observed in any of the cancer patients and two out of three patients with ovarian cancer responded positively and exhibited stable disease.

Chemokine Therapeutics will now proceed with the remaining portion of the clinical trial in which up to 20 additional patients will be treated at 5mg/kg/day. The company expects to enroll the remainder of the patients and complete the current trial by the end of Q3 2007. The company has also accelerated its efforts to initiate a large Phase II program in the U.S. by the end of 2007. Accordingly, a pre-IND meeting has been scheduled with the FDA to discuss the company's future clinical trial program.

"We are very pleased that no dose-limiting toxicities were observed in the first part of the trial and encouraged by the positive outcome in the small group of ovarian cancer patients," said Dr. Hassan Salari, Chemokine Therapeutics president and CEO. "It is quite remarkable to see clinical evidence of efficacy considering these patients have exhausted every therapeutic avenue. We are now looking to rapidly expand the number of patients in Phase II clinical trials of CTCE-9908 to examine the potential broader applicability of this novel oncology drug in the treatment of cancer patients."

The primary purpose of this study is dose-selection and evaluation of safety and tolerability of CTCE-9908. CTCE-9908 is administered via a 30-minute infusion on weekdays over a treatment period of four consecutive weeks (20 doses in total), with each subject receiving a dose level defined by the dose-escalation schedule. The Phase Ib/II trial includes subjects with advanced tumors refractory to the current standard of care. The trial enrolled patients at the Clinical Research Unit of both the Juravinski Cancer Center (Hamilton, ON) and the Sir Mortimer B. Davis - Jewish General Hospital (Montreal, QC).

During the dose-escalation portion of the Phase Ib/II trial, a total of 10 patients were treated with CTCE-9908 with doses ranging from 0.25 to 5 mg/kg/day. Six of the patients received the expected 20 dose course of treatment. Eight of the 10 patients received doses within the expected therapeutic range of 1 to 5 mg/kg/day. Among these patients, there were three with late stage ovarian cancer. Two of the three ovarian cancer patients demonstrated stable disease using the Response Evaluation Criteria in Solid Tumors (RECIST) when comparing the size of target tumors at baseline before treatment with CTCE-9908 to the assessment performed at completion of therapy. One of these patients defined as stable disease had an overall decrease tumour mass with an associated decrease of greater than 50% in CA-125 after nine doses of CTCE-9908 while receiving no other therapy. CA-125 is an ovarian cancer biomarker that is used to monitor disease status and response to treatment.

The daily infusions at all dose levels were generally well tolerated with one subject at the 5mg/kg dose level experiencing moderate localized phlebitis that was attributed to the study drug. No serious adverse events were recorded that were attributed to the use of CTCE-9908 after 20 or more doses.