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SYDNEY, Australia—The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian cancer during 2013 and 14,230 American women will die from the disease, just one set of numbers that has inspired a team-up between Novogen Ltd. and Yale University.
“Although 80 percent of the patients respond to the first line of treatment, most will have a recurrence in five years and many will succumb to the disease,” said Dr. Gil Mor, professor of obstetrics and gynecology and reproductive science at Yale University School of Medicine. “Current chemotherapy is reasonably effective at killing the predominant somatic cancer cells, but by not killing the source of the cancer—the cancer stem cells—the cancer is highly likely to recur. Conventional therapy doesn’t work, and a new approach is needed.”
For that reason, Novogen, an Australian biotechnology company dedicated to developing drugs that provide long-term remission through the successful control of cancer stem cells, has entered into a joint venture with Yale University in the United States that is dedicated to developing personalized approaches for chemotherapy to fight ovarian cancer. Based near Yale’s campus, the joint venture will be known as CanTx Inc. Novogen will own 85 percent of the new company, Novogen CEO Dr. Graham Kelly will be CEO of the new joint venture and the CanTx board will include directors representing both entities.
CanTx will attempt to get Novogen’s “new generation” super- benzopyran drug technology into the clinic for the treatment of ovarian cancer. CanTx’s first development candidate, designed to seek out cancer cells and deliver a payload of a Novogen drug that has been shown to be highly cytotoxic against ovarian cancer cells, including ovarian cancer stem cells, is expected to enter clinical studies in 2014. The investigational product will be administered intra-peritoneally to women with ovarian cancer.
“Our strengths are complementary, which is the very reason for the joint venture,” Kelly said. “Novogen has a drug technology platform, experience in medicinal chemistry and experience in bringing new drugs through to Phase III clinical trials. Yale has developed ovarian cancer cell screening assays and understands the biology of ovarian cancer.”
Yale’s research team developed cell culture techniques allowing the isolation and propagation of ovarian cancer stem cells. Those stem cells then are applied to an athymic mouse model that closely parallels the human experience of initial remission to chemotherapy followed by recurrence of highly chemo-resistant somatic cancer cells. To date, that model has not responded satisfactorily to any standard or experimental treatment, according to Kelly.
Novogen has developed a drug technology platform that targets both ovarian cancer stem cells and somatic cancer cells. In the laboratory, certain lead candidate drugs have proved highly efficient in eradicating both forms of cells.
Mor, who will co-lead clinical development efforts for CanTx, is reportedly the first researcher in the world to isolate ovarian cancer stem cells, the cells responsible for the initial growth of ovarian tumors and their recurrence following chemotherapy. Mor and his team have developed an innovative targeted delivery system for that allows the entire dose of the injected drug to reach the intended target in mice. Typically, when anticancer drugs are injected intravenously, approximately 3 percent of the drug actually reaches the tumor. With this new delivery system, it is anticipated that virtually all the injected drug will reach its target.
Yale is conducting all early preclinical studies on a sponsored research basis. Novogen then will assume responsibility for taking the drug through the later preclinical stages, into gaining an IND and then being taken into and through the clinic.
“The novelty of the CanTx approach is the ability to target the stem cells in particular, and the full spectrum of cells within the hierarchy of an ovarian cancer in general,” Kelly explained. “By eradicating the cancer stem cells in first-line therapy, we hope to achieve as close to 100- percent eradication of the tumor cells as possible, but also to reduce the likelihood of the development of multidrug resistant mechanisms and recurrence.
Mor added, “The result is personalized chemotherapy, in which we identify the individual genotype and match the drug to it. This is the first time we’re combining chemistry with biology in the clinic, understanding the source of the disease and looking at the efficacy of how the drugs kill the cancer cells.”
“Yale and Novogen understood the importance of the problem and the strength of the team to achieve better therapy for ovarian cancer patients,” Mor concluded. “Sometimes groups just converge at the right place and the right time.”