Pharma in silica receives positive feedback from FDA and Health Canada, paving the way for OpPacli™ clinical trials

Quebec City, November 20, 2023 - Pharma in silica, a leading biotechnology company focused on innovative cancer treatments, is pleased to announce positive outcomes from its initial meetings with the U.S. Food and Drug Administration (FDA) and Health Canada regarding the clinical development of OpPacli™, a groundbreaking nanomedicine.

The company sought guidance from both regulatory agencies on the optimal clinical development path for OpPacli™ in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) without actionable genomic alterations. The meetings were instrumental in establishing a clear roadmap for the upcoming preclinical and clinical studies. The FDA, in particular, has indicated that the company may benefit from the 505(b)(2) drug approval pathway, potentially streamlining the process for submitting an Investigational New Drug (IND) application. OpPacli™ is a novel nanomedicine being designed to address unmet medical needs by offering a potentially more effective and tolerable treatment option for patients.

OpPacli™ is a new nanomedicine designed to satisfy unmet medical needs by offering an efficacious and tolerated treatment option for certain solid cancers.

Jean-François Haince, strategic advisor to Pharma in silica, commented, «These positive responses from the FDA and Health Canada are a significant milestone for our OpPacli™ program. They validate our approach and provide a clear path forward for initiating clinical trials. We are excited to continue advancing OpPacli™ towards its goal of improving outcomes for patients with NSCLC.»

About Pharma in silica inc.

Laboratoires Pharma in silica inc. is a preclinical-stage pharmaceutical company based in Québec City's Parc Technologique. Since 2019, it has been developing novel treatments for solid cancers (lung, breast, etc.) using OpPacli™, a patented drug nanocarrier. The company is driven by a dynamic group of chemists, pharmacists and managers led by François Arcand, an experienced life sciences entrepreneur (Medicago, Conferences on Plant-made Pharmaceuticals, ERA Biotech). The company established its own research and production facilities and collaborates with oncology experts and world-renowned research centers and has completed the pre-IND/CTA meetings with the FDA and Health Canada.

For more information

François Arcand
President, Pharma in silica inc
514 994 1023 / 418 874-0054 #233
info@pharma-insilica.com

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