Cellix Biosciences Announces Regulatory Pathway Confirmation for CLX-106 in the U.S.

Cellix Biosciences Inc. (“Cellix Bio”), a development-stage
pharmaceutical company, today announced confirmation from the U.S. Food
and Drug Administration (FDA) that the 505(b)(2) regulatory pathway is
appropriate for development of CLX-106 for treatment of
relapsing-remitting multiple sclerosis (RRMS). CLX-106 is a novel
molecular conjugate designed to deliver an optimal therapeutic profile
of monomethyl fumarate (MMF) for RRMS. MMF is the active moiety of
dimethyl fumarate (DMF), an approved RRMS therapy that achieved global
sales of over $4 billion in 2016. A pre-clinical safety study and a
clinical pharmacokinetic (PK) study will be conducted as expected;
future clinical studies will be designed as suggested by the FDA in a
recent pre-Investigational New Drug (pre-IND) meeting. Cellix Bio has
engaged Camargo Pharmaceutical Services, LLC (“Camargo”) for regulatory
consulting and strategic development services for CLX-106 in the United
States.

Mahesh Kandula, CEO of Cellix Bio, stated, “We are excited with the
responses we have received on our development plan from the FDA. With
the FDA’s confirmation that the 505(b)(2) pathway is acceptable for
CLX-106, we expect to have relatively lower drug development costs and a
faster path to approval.”

Camargo is the global development and commercialization partner with a
proven ability to help bring life-changing therapies to the market
faster and more cost-effectively. “Camargo’s goal is to guide our
clients in the most cost- and time-effective manner through the
505(b)(2) regulatory pathway, while driving commercial success for our
client-partners,” said Ruth Stevens, Chief Scientific Officer and
Executive Vice President, Camargo Pharmaceutical Services. “We look
forward to continuing work with Cellix Bio to advance its treatment for
RRMS to benefit patients in need worldwide.”

About Cellix Biosciences

Cellix Bio is an innovative biopharmaceutical company founded by Mahesh
Kandula, CEO and innovator of SynergixTM technology, and
Subbu Apparsundaram, CDO & COO. Cellix Bio is focused on the development
of innovative technologies that have the potential to make a significant
medical or commercial impact with value driven clinical outcomes. Cellix
Bio works closely with the scientific community, universities and
research institutions to advance and build the value of SynergixTM
technology, develop the most promising intellectual property, and create
value for its stakeholders and investors. Cellix Bio has a robust
pipeline of new medicines addressing unmet medical needs across diverse
therapeutic areas including neurology, inflammation and metabolic
diseases. For more information on Cellix Bio, visit http://www.cellixbio.com.

About Camargo Pharmaceutical Services

Camargo offers a full portfolio of pharmaceutical services from concept
through commercialization to improve medicines. Founded in 2003, Camargo
has emerged as one of the recognized experts and industry leaders
utilizing the FDA 505(b)(2) approval pathway. The company is passionate
about the client’s success and the differences we can make in the lives
of others. Camargo’s global reach and client base extends to more than
25 countries. Camargo is headquartered in Cincinnati, Ohio. For more
about Camargo Pharmaceutical Services, visit http://camargopharma.com.

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