A Phase II clinical trial of SG2000 in ovarian cancer, being sponsored by the National Cancer Institute (NCI), is now actively recruiting patients for treatment for the treatmet of various forms of 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.

Trial design
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.

Platinum-resistant
“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,” noted Marta Ann Crispens, MD, FACOG, Principal Investigator, Vanderbilt University Medical Center.

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Unmet need
Commenting on the trial, Chris Martin, CEO ofSpirogen 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.”

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New class of agents
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.

“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,” noted Tomasz Sablinski, MD, Head of Development at Celtic Therapeutics, who provided funding in support of the Phase II clinical trial, and has an option to acquire and develop SG2000.

The researchers are also also initiating a clinical trial for SG2000 in leukemia, which they anticipate will commence by year end.

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