Splash Pharmaceuticals has successfully completed the safety stage of its Phase 1 trial testing a combination of SPL-108 and chemotherapy in platinum-resistant ovarian cancer patients, the company announced in a press release.
Taking place at Rutgers Cancer Institute of New Jersey, the open-label trial (NCT03078400) is now recruiting participants into its dose escalation phase.
“The target, mechanism of action, and clinical data all support the idea of further testing SPL-108 and paclitaxel in ovarian cancer patients,” David Nelson, president and CEO of Splash, said in the release. “We believe that SPL-108 will be synergistic with other anti-tumor drugs as well and could be applicable in many different tumor types including breast and endometrial cancers. We are pleased that the first patients have cleared this critical safety hurdle.”
While SPL-108’s mechanism of action is not fully known, researchers believe it works by targeting a surface protein, called CD44, whose expression is increased in cancer stem cells.
Phase 1 and 2 trials with more than 100 patients have already tested the investigational therapy, which was reported to have excellent safety and tolerability. In preclinical studies with animal models for ovarian, breast, endometrial, prostate, liver and brain cancers, SPL-108 showed significant anti-cancer effects.
The ongoing trial is twofold, including a safety phase and a dose-escalation phase.
In the safety phase, researchers assessed the safety of SPL-108 in two groups of patients, with up to six participants each. Patients in the first group received SPL-108 once daily, plus weekly Taxol (paclitaxel), a chemotherapy approved for ovarian cancer, while those in the second group received SPL-108 twice daily, along with Taxol.
In the expansion phase, up to 12 ovarian cancer patients will receive the dose deemed safe during the first phase, together with weekly doses of Taxol.
The study’s primary objective is to assess the incidence of adverse events over a six-month period. Additional goals include objective response and quality of life measurements.
“Ovarian cancer is often first diagnosed in advanced stages and treated with platinum-based chemotherapy. For many patients, their disease will become resistant to this treatment. As a researcher, I am happy to have an opportunity to translate the discoveries in my laboratory and use SPL-108 in the clinic to further identify much needed therapy alternatives for this population,” said Lorna Rodriguez, MD, PhD, the study’s principal investigator and chief of the Gynecologic Oncology Program at Rutgers Cancer Institute.