FDA Clears IND Application for Ph 1b Study of PTM-101 for the Localized Treatment of Pancreatic Cancer
“Receiving FDA clearance for our phase 1b study of PTM-101 marks a pivotal achievement for PanTher and represents a significant milestone in our mission to transform clinical outcomes for patients with challenging pancreatic cancer diagnoses,” said Laura Indolfi, PhD, Chief Executive Officer, and co-founder of PanTher Therapeutics. “This study will build upon the company’s positive, early clinical data in patients with borderline resectable and locally advanced PDAC. PTM-101 was developed using PanTher’s Sagittari™ drug development platform, which creates products that provide continuous delivery of high drug concentrations exclusively at the tumor site for an extended period of time. This novel approach, which maximizes killing of tumor cells, has not previously been possible with other technologies.”
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
