Pharmaceutical company Rexahn has submitted a Phase II protocol to the US Food & Drug Administration for the study of its oncology drug product Archexin, as a treatment for certain ovarian cancers.
According to the protocol, this Phase II study will evaluate the safety and efficacy of Archexin in combination with chemotherapeutic drugs carboplatin and paclitaxel as a second-line therapy in patients who have been determined to be platinum-sensitive following induction therapy relapse.
The trial will be carried out in multiple centers across the United States and will feature two arms: one arm will receive carboplatin and paclitaxel and the other arm will receive carboplatin, paclitaxel and Archexin. A number of measures of clinical benefit are to be assessed as part of the protocol.
Archexin is a first-in-class, potent Akt protein kinase inhibitor with the potential to inhibit cancer cell survival and proliferation, angiogenesis and drug resistance. According to a Phase I clinical trial, Archexin has a very good human safety profile, with fatigue being the only side effect.
Currently, Archexin has FDA Orphan drug designation for five different cancer types, including renal cell carcinoma, glioblastoma, pancreatic, stomach and ovarian cancer.
"Treatment options are limited for patients who are stricken with ovarian cancer, therefore we look forward to investigating Archexin as a potential combination treatment for this disease.” said Rick Soni, President of Rexahn. “To date, Archexin has demonstrated promising safety profile, and it has been granted orphan drug designation in ovarian cancer and several other solid tumors by the FDA. We expect to report preliminary Phase IIa results from our pancreatic cancer trial with Archexin later this year.”
Source: Therapeutics Daily
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