Ovarian Cancer

The American Cancer Society estimates that approximately 22,000 women a year will be newly diagnosed with ovarian cancer and approximately 14,000 women will die from the disease in the U.S. each year1.

Ovarian cancers are commonly treated with platinum-based chemotherapy regimens. Initial tumor response rates are relatively high. However, up to 75% of ovarian cancer patients who respond to initial treatment will relapse within approximately 18 months after first therapy. In published studies, median survival in platinum-resistant recurrent ovarian cancer patients ranged from six to nine months2.

VAL-083 for the Treatment of Ovarian Cancer

A Distinct Mechanism of Action Against Ovarian Cancer

VAL-083 offers a distinct mechanism of action versus platinum-based chemotherapy currently used in the treatment of ovarian cancer. Our research has demonstrated that the anti-cancer activity of VAL-083 is less dependent on the status of tumor protein p53 than that of cisplatin. p53 is mutated in the majority of ovarian cancers leading to treatment resistance. In addition, synergy was observed when VAL-083 was combined with platinum-based chemotherapy or PARP inhibitors in our laboratory studies.

The potency of VAL-083 is increased when a cell's homologous recombination (HR) DNA repair mechanism is impaired, further demonstrating that VAL-083-induced DNA lesions are repaired via the HR pathway. Deficiencies in HR are common in ovarian cancer suggesting VAL-083 has increased anti-cancer activity against HR-impaired ovarian cancer.

These results support VAL-083's potential as a treatment option for ovarian cancer patients who have failed 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 PARP inhibitors.

The FDA Office of Orphan Products Development (OOPD) has granted us orphan drug designation for VAL-083 in the treatment of ovarian cancer.

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  1. NCI-SEER: Surveillance-Epidemiology and End Results
  2. Herzog, Clin Cancer Res (2004)