MONTCLAIR, N.J., September 22, 2016 /PRNewswire/ -- Nexus BioPharma, Inc., (OTC-BB NEXS), a company specializing in the development of a weight loss drug therapy, announced today the appointment of Helen Stefanovic as Director of Regulatory Affairs. Ms. Stefanovic has broad and extensive experience in all aspects of the FDA drug approval process and has worked on product approvals in endocrinology, biologics, biosimilars, vaccines & anti-infectives, and oncology. She served as Manager, Science Policy, Corporate Strategic Planning and Policy at Pfizer Inc, World Headquarters. Previously she was Project Leader, Regulatory Affairs, Bristol-Myers Squibb Canada. She began her career in regulatory affairs at Sandoz, Canada where she was instrumental in the successful registration of the key products SANDIMMUNETM and NEORALTM. Ms. Stefanovic earned a B.Sc. Biological Sciences at Concordia University, Montreal, Quebec and a M.Sc. Microbiology & Immunology at the University of Ottawa, Ontario.
Warren C. Lau, President and CEO of Nexus stated, “We are pleased to have Helen on board. She has the expertise and experience to plan the company’s pre-IND program and push toward our goal of commencing human clinical trials before the end of next year.”
“I am looking forward to the challenge of bringing this important life-changing product to the market in the most expeditious time frame possible,” said Stefanovic. “We will be exploring all avenues that might include Orphan Drug Designation for Prader Willi Syndrome, as well as Accelerated Approval Pathway, Breakthrough and Fast Track Designation to compress the timeline.” About Nexus BioPharma, Inc. www.nexusbiopharma.com
About Nexus BioPharma, Inc. www.nexusbiopharma.com
Nexus BioPharma, Inc. is developing a new weight loss drug that works differently than any currently available prescription drug. It adjusts the body’s metabolism to increase the burning of fat by activating the AMPK metabolic pathway, the same pathway activated by intense physical exercise.
The underlying biochemistry was described in an article in the journal Cell Metabolism by Claire C. Bastie, and Jeffrey E. Pessin, entitled "Fyn-Dependent Regulation of Energy Expenditure and Body Weight Is Mediated by Tyrosine Phosphorylation of LKB1". Cell Metab. 2010 Feb 3;11(2):113-24
In completed pre-clinical trials of the pharmaceutical activation of this pathway, test subjects showed reduced fat mass with no loss of lean muscle mass, plus a higher rate of energy expenditure, increased insulin sensitivity, increased fatty acid oxidation, improved plasma and tissue triglyceride levels, with lower cholesterol. Upon translation of this pharmaceutical activation to humans, these effects are expected to have a significant impact on obesity and diabetes.
Using the most advanced high throughput screening technology, Nexus BioPharma has identified small molecule compounds in a number of discrete chemical structure families that can efficiently activate the pathway. The Company has filed for intellectual property protection on a selection of compounds in a number of discrete chemical backbones. The Company's goal is to advance to pre-IND trials in preparation for FDA human trials of a drug that will safely mimic this effect in humans.
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This press release may contain certain "forward-looking statements" relating to the business of Nexus BioPharma, and its subsidiary companies. All statements, other than statements of historical fact included herein are "forward-looking statements" including statements regarding: the impact of the proceeds from the private placement on the Company's short term business and operations,; the general ability of the Company to achieve its commercial objectives, including the ability of the Company to sustain growth; the business strategy, plans and objectives of the Company and its subsidiaries; and any other statements of non-historical information. These forward-looking statements are often identified by the use of forward-looking terminology such as "believes," "expects" or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company's periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.