On September 13, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), reported that the Company and its collaborators from the University of Texas MD Anderson Cancer Center presented new data in a research poster entitled "Activity of dianhydrogalactitol (VAL-083) in ovarian tumor models, sensitive or resistant to cisplatin" at the 11th Biennial Ovarian Cancer Research Symposium (Press release, DelMar Pharmaceuticals, SEP 13, 2016, View Source [SID:SID1234515118]).

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The data, presented on the evening of Monday, September 12th at the Rivkin Center for Ovarian Cancer in Seattle, Washington, support a distinct mechanism of action for VAL-083 versus platinum-based chemotherapy currently used in the treatment of ovarian cancer.

"We were pleased to present these data, which are highly supportive of VAL-083’s potential as a new therapeutic option for ovarian cancer patients whose treatment is underserved by currently available therapy. We plan to work with our advisors to develop a strategy to advance VAL-083 into clinical trials for the treatment of ovarian cancer, either as a single-agent or in combination with other approved agents," said Jeffrey Bacha, Chairman & CEO of DelMar.

The researchers also reported observations of synergy when VAL-083 was combined with platinum-based chemotherapy or PARP inhibitors and that the potency of VAL-083 is increased when a cell’s homologous recombination ("HR") DNA repair mechanism is impaired, further suggesting that VAL-083-induced DNA lesions are repaired via the HR pathway.

Dr. Dennis Brown, DelMar’s Chief Scientific Officer noted, "These data are important because they provide further support of our previous research suggesting that VAL-083 imparts its anti-cancer activity via double-strand breaks as a result of DNA cross-links at the N7-position of guanine. Homologous recombination is the mechanism generally employed by cells to repair damage resulting from DNA double strand breaks. Deficiencies in HR are a hallmark of many cancers, including ovarian cancers, while normal cells retain HR function. This may explain why VAL-083 has been observed to possess high activity against cancer yet exhibit limited toxicity against normal cells."

In summary,

VAL-083 demonstrated cytotoxic activity against all ovarian cancer cell lines tested and is substantially less dependent on wild-type p53 for cytotoxic activity.
VAL-083 was able to circumvent 70-85% of cisplatin-resistance in an ovarian cancer cell line panel with several known p53 mutations and displays synergy with cisplatin in p53 mutant cell line H1975.
VAL-083 demonstrated synergy with AstraZeneca’s PARP inhibitor Olaparib in ovarian cancer cell line A2780.
The potency of VAL-083 activity was increased when HR was impaired in A2870 cells with BRCA1 knockdown, demonstrating that VAL-083 induced DNA-lesions are repaired via HR.
"Taken together, these results support VAL-083’s potential as a treatment option for ovarian cancer patients failing platinum-based therapy particularly in an HR-impaired setting. They further suggest a potential benefit of therapeutic combination regimens containing VAL-083 plus platinum-based chemotherapy or VAL-083 in combination with a PARP inhibitor such as Olaparib," concluded Mr. Bacha.

VAL-083 is a "first-in-class" small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia in prior clinical trials sponsored by the US National Cancer Institutes both as a single-agent and in combination with other treatments. DelMar recently announced completion of Phase I/II clinical trials with VAL-083 as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The Company plans to advance VAL-083 into a pivotal Phase III clinical trial for refractory GBM and also plans to advance VAL-083 into clinical trials for other solid tumors such as non-small cell lung cancer and ovarian cancer.

In April 2016, the FDA Office of Orphan Products Development (OOPD) granted orphan drug designation for VAL-083 in the treatment of ovarian cancer. VAL-083 had earlier received an orphan designation for glioma and medulloblastoma in the United States and for glioma in Europe.

DelMar CEO to Present Today at 18th Annual Rodman & Renshaw Global Investment Conference in New York

Jeffrey Bacha, DelMar’s president and CEO, will deliver a corporate address today at the 18th Annual Rodman & Renshaw Global Investment Conference. Mr. Bacha’s presentation is scheduled for 10:50-11:15 AM Eastern Time in the Kennedy II Ballroom at the Lotte New York Palace Hotel. A live webcast of the presentation will be available by accessing a link that will be posted on the Company’s website (www.DelMarPharma.com). A webcast replay will be available approximately two hours after the presentation ends and will be accessible for one month.

About Ovarian Cancer

According to Evaluate Pharma, the annual market for ovarian cancer therapies is expected to reach approximately $570 million in 2016, and is projected to grow to more than $3.5 billion in 2022. The American Cancer Society estimates that approximately 22,000 women will receive a new diagnosis of ovarian cancer and approximately 14,000 women will die from ovarian cancer in the United States each year. Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.

Ovarian cancers are commonly treated with a platinum-based chemotherapy regimen. Initial tumor response rates are relatively high; however, as up to 75% of ovarian cancer patients who respond to initial treatment will relapse within approximately 18 months after completing first-line therapy. In published studies, median survival in platinum-resistant recurrent ovarian cancer patients ranged from six to nine months.