NEW YORK, NY / ACCESSWIRE / September 18, 2019 / CLS Therapeutics, a privately held oncology-focused gene therapy company developing a platform technology based on the identification of a novel therapeutic target that can be utilized for many cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CLS-014 for the treatment of pancreatic cancer.h.
CLS-014, the Company’s lead product candidate, has demonstrated in preclinical studies the potential to significantly suppress the growth of pancreatic adenocarcinoma and prevent the metastasis formation. CLS Therapeutics expects to file an investigational new drug application (IND) with the FDA for CLS-014 in 2021.
“Receiving Orphan Drug Designation marks a major milestone for CLS-014 and an important step forward for our transformative anticancer gene therapy platform,” commented George Tetz, M.D., Ph.D., Co-Founder and CEO. “There remains a significant unmet need for the treatment of pancreatic cancer that is the third leading cause of cancer-related deaths in the U.S. Current therapies are not sufficiently effective for pancreatic cancer with the lowest 5-year survival rate of any cancer (8%) attributing to over 45,000 people dying from it in the U.S. last year. CLS has identified blood tumor-derived cell-free DNA as a new therapeutic target for the successful anticancer therapy which has been independently confirmed by leading universities and research groups. Importantly, we have shown that with our gene therapy approach, we can significantly decrease the primary tumor growth and prevent metastases formation in pancreatic cancer models.”
The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.
For more information on CLS Therapeutics, please visit www.clstherapeutics.com.
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CLS Therapeutics Inc., a preclinical-stage biopharmaceutical company developing next-generation gene therapy anticancer drugs, today announced that George Tetz, MD, Ph.D., Chief Executive Officer, presented the poster, “TRANSFORMATIVE ANTICANCER GENE THERAPY PLATFORM ADDRESSING A NOVEL THERAPEUTIC TARGET” at the Targeting Tumor Heterogeneity Conference organized by the New York Academy of Sciences May 8, 2019, in New York, New York.
NEW YORK, March 29, 2019 – CLS Therapeutics, Inc., today announced a poster presentation “First-In-Class-AAV-Based Gene Therapy For Pancreatic Cancer Based On The Destruction Of Cell-Free DNA with Vector-delivered DNase I” at the New York Academy of Sciences symposium “Cancer Metabolism and Signaling” being held on May 9, 2019, in New York City. The presentation includes the first animal data for the activity of AAV-based vector (in silico designed ) encoding DNase I of the treatment of pancreatic cancer animal model.
CLS Therapeutics Inc., a preclinical-stage biopharmaceutical company developing next-generation gene therapy anticancer drugs, today announced that George Tetz, MD, Ph.D., Chief Executive Officer, presented the poster, “CELL-FREE TUMOR DNA AND NEUTROPHIL EXTRACELLULAR TRAPS AS NOVEL THERAPEUTIC TARGETS FOR PANCREATIC CANCER” at the Frontiers in Cancer Immunotherapy organized by the New York Academy of Sciences May 14-15, 2019, in New York, New York.