NEW YORK, Oct. 26, 2017 (GLOBE NEWSWIRE) -- AIT Therapeutics Inc. (OTC:AITB), a clinical-stage biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with serious lung infections, today announced it has made three key new hires to support its clinical development and regulatory progress. Joining the Company are Giora Davidai, M.D. as Chief Medical Officer, Rhona Shanker as Director of Regulatory Affairs, and Professor Asher Tal, M.D. as Senior Vice President of Clinical Research.
“I am delighted to welcome these extraordinarily talented industry veterans to our growing team. As we move toward initiating two pivotal clinical studies in 2018 with our inhaled NO therapy, their knowledge and experience will be invaluable for AIT,” said Steve Lisi, Chairman and Chief Executive Officer of AIT Therapeutics. “Giora provides us with critical expertise in executing advanced clinical and post-marketing studies. Rhona’s vast knowledge of the many facets of the regulatory process gives the AIT team the structure it needs to succeed. Asher has helped AIT since the early days, so to have him come on board in this role is quite special for us.”
Giora Davidai, M.D., joins AIT from Boehringer Ingelheim (BI), where he oversaw clinical development, most recently as Executive Director and Department Head of Established Products in Clinical Development and Medical Affairs. Dr. Davidai also served as the head of Cardiovascular, Metabolic, CNS, and Respiratory, Clinical and Medical Affairs. Prior to BI, Dr. Davidai held various management roles at Glaxo Wellcome (GW), establishing the Global Bone Research team within GW R&D, in addition to leading clinical development as Global Medical head for Migraine, Headache, Epilepsy, and Smoking Cessation. Dr. Davidai is a Board-Certified physician in Pediatrics and Pediatric Nephrology and received his medical degrees from Tel Aviv Sackler School of Medicine, Haifa Medical Center and Duke University School of Medicine.
Rhona Shanker joins AIT as a seasoned regulatory affairs expert having reviewed thousands of medical device applications during her 35-year career as an FDA/CDRH/ODE expert regulatory reviewer and FDA regulatory consultant. Throughout her distinguished career, Ms. Shanker focused on developing strategies for complying with FDA pre- and post-market regulatory requirements, including: developing regulatory strategies for pre-market submissions, planning IDE, 510(k), PMA, HUD, HDE, and CE projects; preparing 510(k), IDE, PMA, Design Dossiers, and Clinical Evaluation Reports for submission. Ms. Shanker has been an invited speaker at multiple medical and regulatory affair conferences, expositions and webinars. She graduated from Emory University with a degree in Biology and has co-authored several professional publications.
Asher Tal, M.D., Professor of Pediatrics and Founder of the Pediatric Pulmonary Unit at Soroka Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel, joins AIT as Senior Vice President of Clinical Research. During his 25 years as head of the Department of Pediatrics at Soroka, Professor Tal authored or co-authored over 100 publications. His research interests include childhood asthma, bronchiolitis and wheezing in infancy, sleep-disordered breathing, pediatric and adult obstructive sleep apnea syndrome and insomnia. During his esteemed career, Dr. Tal was responsible for developing the Tal score for assessing the severity of bronchiolitis in infants, which is now the accepted clinical measure of severity of respiratory infections in clinical and research settings.
About AIT Therapeutics Inc.
AIT Therapeutics Inc. is a clinical-stage biopharmaceutical company using nitric oxide (NO) to treat respiratory and other diseases. The Company is currently applying its therapeutic expertise to treat lower respiratory tract infections that are not effectively addressed with current standards of care. AIT Therapeutics is advancing its revolutionary NO respiratory targeted system in clinical trials for the treatment of bronchiolitis and nontuberculous mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.
This press release contains “forward-looking statements.” Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” “likely,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; and our short operating history. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.
Steven Lisi, Chief Executive Officer
AIT Therapeutics, Inc.
LifeSci Advisors, LLC
(646) 597 6989
Source:AIT Therapeutics, Inc.