Spirogen, Celtic Therapeutics announces initiation of Phase II ovarian cancer trial with SG2000

Spirogen Limited (the "Company") and Celtic Therapeutics Holdings LP ("Celtic Therapeutics") announced today the commencement of a Phase II clinical trial of SG2000 in ovarian cancer.  The trial is being sponsored by the National Cancer Institute (NCI) of the USA, and is now actively recruiting patients for treatment.

The open-label Phase II study will evaluate the overall response rate of SG2000 in approximately 50 patients with recurrent, resistant or refractory epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.  The trial will be conducted at a consortium of four leading southeast U.S. cancer centers, led by Vanderbilt-Ingram Cancer Center, and including Moffitt Cancer Center at the University of South Florida, Winship Cancer Institute at Emory University and Massey Cancer Center at Virginia Commonwealth University.

"We are delighted to have commenced this important trial for SG2000 in platinum-resistant and refractory ovarian cancer.  We believe that if SG2000 demonstrates similar activity in this Phase II trial to that demonstrated in vitro and in patients in four separate Phase I trials with more than 60 patients, it has the potential to be an important new therapeutic for women with ovarian cancer," said Marta Ann Crispens, MD, FACOG, Principal Investigator, Vanderbilt University Medical Center.

Chris Martin, CEO of Spirogen said, "The initiation of this Phase II ovarian cancer trial with SG2000 is an important milestone in developing a new therapy for this high unmet medical need.  We are excited to be working with both the NCI for this trial, including its impressive team of investigators, and also of course Celtic Therapeutics and their very experienced drug development team."

Tomasz Sablinski, MD, Head of Development at Celtic Therapeutics said: "SG2000 is an exciting compound, which acts by a novel mechanism, and may be a very valuable therapeutic alternative for oncologists, not only in treating ovarian cancer patients but also in the other indications in which we are currently initiating clinical trials."

Celtic Therapeutics provided funding in support of the Phase II clinical trial, and has an option to acquire and develop SG2000.  Celtic Therapeutics and Spirogen are also initiating a clinical trial for SG2000 in leukemia, which they anticipate will commence by year end.