Sep 18, 2019
CLS Therapeutics Receives Orphan Drug Designation for CLS-014 for the Treatment of Pancreatic Cancer

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.

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Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

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Investor/Media Contact

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Jenene Thomas
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Sep 29, 2022

NEW YORK, NY /  September 28, 2022 / CLS Therapeutics, an oncology-focused gene therapy company that utilizes Extracellular DNA and NETs as novel anticacer therapeutic targets, announces that its project entered the final of “Creating the World·Sailing to the Future” Innovation and Entrepreneurship Competition 2022 Hangzhou.

Apr 07, 2021

NEW YORK, NY /  April 06, 2021 / CLS Therapeutics,  cancer gene therapy company utilizing a novel therapeutic target, announces presentation at the upcoming 2021 American Society of Gene & Cell Therapy (ASGCT) 24th Annual Meeting.

May 10, 2019

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.