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Celtic Therapeutics and Spirogen Limited Release: Commencement of a Phase II Clinical Trial of SG2000 in Ovarian Cancer


9/15/2010 12:04:50 PM

LONDON and NEW YORK, Sept. 15 /PRNewswire/ -- 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.

About Resistant Ovarian Cancer

Ovarian cancer is the sixth most commonly diagnosed cancer in women and the eighth leading cause of cancer death among women worldwide, according to the American Cancer Society. Annually, an estimated 230,000 women are diagnosed with ovarian cancer around the world and around 140,000 die from the disease. Although treatable when detected early, most diagnoses occur at advanced stages, and at that stage 5-year survival rates are 69% for patients with regionally advanced disease and 30% for patients with distant metastases.

ABOUT SG2000

SG2000 (SJG-136/BN2629/NSC 694501) is a small molecule which spans six base pairs of DNA in the minor groove, inducing DNA cross links, and is currently undergoing clinical development in refractory solid tumors and hematological malignancies under a CRADA (Cooperative Research And Development Agreement) with the Division of Cancer Treatment and Diagnosis as supported by NIH U01 CA099177 and M01 RR00095 grants. The agent belongs to an entirely new class of DNA minor groove binding agents designed to minimize detection of the induced DNA lesions by the DNA repair machinery and encouraging clinical results have been reported in refractory solid tumors cancer at recent ASCO meetings.

ABOUT SPIROGEN LIMITED

Spirogen is a privately owned UK company, founded in 2001 by Professor David Thurston and Dr. Phillip Howard (now at the School of Pharmacy, University of London), Professor John Hartley (University College London) and Dr. Chris Martin. The company is pioneering the discovery and development of a unique class of low molecular weight sequence-specific DNA-interactive drugs designed to treat gene-mediated diseases. Spirogen's proprietary chemistry-based platform technology forms the basis of a research effort that began over a decade ago to develop novel therapeutics with potential application in a number of markets. Spirogen's website is www.spirogen.com.

ABOUT CELTIC THERAPEUTICS

Celtic Therapeutics Management L.L.L.P. ('Celtic') was founded in 2007 by Stephen Evans-Freke and Dr. Peter B. Corr, as a successor firm to Celtic Pharma Management L.P. The Celtic private equity strategy is to acquire promising therapeutic products that have achieved proof of principle in human clinical studies. Celtic's in-house team of senior pharmaceutical development executives then establishes the clinical and regulatory strategies for the development of its products and oversees its execution. Upon achieving value enhancing milestones, Celtic partners with major pharmaceutical companies for continued development and commercialization. Based in the U.S. Virgin Islands, Celtic has origination, acquisition and development operations in New York City and Lausanne, Switzerland. For further information, please visit Celtic's website, www.celtictherapeutics.com.

SOURCE Celtic Therapeutics


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