Enrollment starts in Ph 2 Stenoparib trial in Advanced Ovarian Cancer Patients
”The intensive review and finalization of this new protocol, with feedback from the FDA, the IRB and our treating physicians marks a critical milestone in our effort to accelerate stenoparib as a potentially safer, more effective alternative to additional lines of chemotherapy,” said Thomas Jensen, CEO of Allarity Therapeutics. “Importantly, this new protocol simultaneously allows us to accelerate the development of stenoparib alongside the stenoparib-DRP as a companion diagnostic. Pushing both in parallel will generate the critical data needed to support timely, connected regulatory approval for both. We are very excited about the thoughtful, unique design of this new protocol as it allows us to quickly and effectively get stenoparib into the hands of the world’s best gynecologic oncologists, benefiting patients who need safer and more effective treatment options than the toxic chemotherapy options they would otherwise have to rely upon. We are particularly excited about the prospects of this trial advancing stenoparib’s journey toward commercialization.”
Share:
More News
PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is
