U.S. Food and Drug Administration approves application for Investigational New Drug; Phase I Clinical Study set to commence enrolment in late 2018

24 September 2018 | AIM:TILS

THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

 

Tiziana Life Sciences plc (AIM: TILS), a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, is pleased to announce that further to the announcement made on 16 August 2018 the Investigational New Drug application (“IND”) made in collaboration with the Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts (“BWH”) to initiate Phase 1 clinical trials with Foralumab (TZLS-401), has been approved.

 

The enrolment for this first-in-human Phase 1 clinical study will commence in late 2018 with first dosing expected to begin by November. This single-site study will be conducted at BWH and will be initiated to evaluate safety, tolerability and immunomodulatory effects of nasally administered Foralumab in healthy volunteers with a stable formulation at 10, 50 and 250 µg/day using a nasal spray device. Major objectives of this study are to demonstrate safety and immunomodulatory effects of a potentially revolutionary immunotherapeutic approach for the treatment of neurodegenerative diseases, such as progressive multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS).

 

The Company plans to submit an additional IND application to administer oral formulation of Foralumab to healthy volunteers in a Phase 1 clinical trial targeted at the treatment of autoimmune and inflammatory diseases such as non-alcoholic steatohepatitis or fatty liver disease (NASH) and Crohn’s disease.

 

The person who arranged for the release of this announcement on behalf of the Company was Dr. Kunwar Shailubhai, Chief Executive Officer of Tiziana. 

 

About Dr. Howard Weiner

 

Dr. Howard L. Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners MS Center and Co-Director of the Ann Romney Center for Neurologic Diseases at BWH in Boston. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer's disease, amyotrophic lateral sclerosis, stroke and brain tumors. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 mAbs to induce regulatory T cells for the treatment of these diseases.

 

About Harvard Medical Centre and BWH

 

BWH is located adjacent to Harvard Medical School.  It is the largest hospital of the Longwood Medical and Academic Area in Boston, Massachusetts, USA. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare, the largest healthcare provider in Massachusetts. Brigham and Women's Hospital conducts the second largest hospital-based research program in the world, with an annual research budget of more than $630 million.  Pioneering milestones include the world's first successful heart valve operation and the world's first solid organ transplant.

 

About Tiziana Life Sciences

 

Tiziana Life Sciences is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. We believe Foralumab is the only fully human anti-CD3 mAb in clinical development in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as NASH, primary biliary cholangitis (PBS), ulcerative colitis, MS, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

 

Forward-looking statements

 

This news release contains forward-looking statements that reflect Tiziana Life Science’s current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the clinical benefits of Foralumab and the safety profile and commercial potential of Foralumab. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including, inter alia, the success of the Company’s research strategies, the applicability of the discoveries made therein and the successful and timely completion and uncertainties related to the regulatory process. A further list and description of risks and uncertainties associated with an investment in Tiziana Life Sciences can be found in its filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Tiziana Life Sciences undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

 

For more information go to http://www.tizianalifesciences.com

 

Contacts:

 

Tiziana Life Sciences plc

Gabriele Cerrone, Chairman and founder                               +44 (0)20 7493 2853

 

 

Cairn Financial Advisers LLP (Nominated adviser)

Liam Murray / Jo Turner                                                            +44 (0)20 7213 0883

 

Stockdale Securities (Broker)

Antonio Bossi / Andy Crossley                                                 +44 (0)20 7601 6100