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29-Oct-2018

Cellix Biosciences Completes Pre-IND Meeting with FDA on CLX-103 for Ulcerative Colitis

Cellix Biosciences Inc. (“Cellix Bio”), a development-stage pharmaceutical company, today announced successful completion of a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for the development of CLX-103, a novel molecular conjugate of mesalamine for the treatment of mild to moderate ulcerative colitis. CLX-103 is designed to specifically target the release of mesalamine within the lower gastrointestinal tract. This will potentially allow local exposure to mesalamine, while minimizing systemic exposure to potentially reduce the known side effects of mesalamine. At the Pre-IND meeting, Cellix Bio received guidance for the development of CLX-103 and, accordingly, Cellix Bio plans to submit its IND application by the second quarter of 2019. Mahesh Kandula, Founder, Cellix Bio India, stated, “We are excited by the responses we have received from the FDA for the development of this novel prodrug of mesalamine. We believe it has the potential to improve the therapeutic profile mesalamine for the treatment of ulcerative colitis.” Cellix Bio has engaged Dr. Frank Diana (Chemistry, Manufacturing and Controls) and Dr. Mudher Albassam (Non-clinical) to bolster its pipeline development team. Cellix Bio also has engaged Camargo Pharmaceutical Services, LLC, to lead the regulatory and strategic development of CLX-103 in the United States.

About Cellix Biosciences

Cellix Bio is an innovative biopharmaceutical company founded by Mahesh Kandula, innovator of SynergixTM technology, and Subbu Apparsundaram. Cellix Bio focuses on improving the therapeutic profile of existing drugs for improved treatment outcome for patients. Cellix Bio works closely with the scientific community, universities and research institutions to advance and build the value of SynergixTM technology, develop promising intellectual property, and create value for its stakeholders and investors. Cellix Bio aims to develop a robust pipeline of new medicines addressing unmet medical needs across diverse therapeutic areas. For more information on Cellix Bio, visit http://www.cellixbio.com.

About Camargo Pharmaceutical Services

Camargo is the preferred partner for the ideation, development, and approval of advanced medicines that help people live a better life. Camargo offers a full portfolio of pharmaceutical services from concept through commercialization to improve medicines. Camargo’s global reach and client base extends to more than 32 countries. Camargo is headquartered in Cincinnati, Ohio. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com.

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Last Updated: 29-Oct-2018