MTPH Midatech Pharma Plc

TIDMMTPH

RNS Number : 4269V

Midatech Pharma PLC

13 December 2021

13 December 2021

Midatech Pharma PLC

("Midatech" or the "Company")

Investigational New Drug Application for Study of MTX110

in Recurrent Glioblastoma (GBM) Becomes Effective

Midatech Pharma PLC (AIM: MTPH; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, is pleased to announce that its Investigational New Drug (IND) application for a Phase 1 study of MTX110 , a panobinostat complex to be administered by convection enhanced delivery in patients with recurrent glioblastoma multiforme (rGBM), has been cleared by the US FDA. Accordingly, Midatech has initiated preparations for a study start in the first half of 2022 .

Employing the Company's MidaSolve(TM) technology, MTX110 solubilises panobinostat, a histone deacetylase (HDAC) inhibitor currently used in the treatment of multiple myeloma. In a liquid formulation as MTX110, panobinostat can be delivered directly to a patient's tumour under constant pressure via a catheter system (Convection Enhanced Delivery, or "CED") thereby bypassing the blood-brain barrier and allowing for high drug concentrations and broader drug distribution in and around the tumour while simultaneously minimising systemic toxicity and other side effects. Panobinostat has demonstrated high potency against patient-derived tumour cells in in vitro and in vivo models.

GBM is the most common and aggressive form of brain cancer in adults, usually occurring in the white matter of the cerebrum. Treatments include radiation, surgical resection and chemotherapy although, in almost all cases, tumours recur. There are approximately 2-3/100,000(1) diagnoses of GBM per annum. Survival with standard of care treatment ranges from approximately 13 months in unmethylated MGMT patients to approximately 30 months in highly methylated MGMT patients(2) . Glioblastoma is an intractable brain cancer.

The primary objective of the Phase I study will be to assess the safety and tolerability of MTX110 in patients with rGBM. The study is expected to include two clinical centres in the US and to begin recruiting H1 2022.

Dmitry Zamoryakhin, Chief Scientific Officer of Midatech, said:

"Our solubilising technology in combination with a CED system offers the potential to deliver significantly higher doses of panobinostat, a potent HDAC inhibitor, directly to the tumour. Importantly, this targeting approach is designed to limit systemic circulation of drug and therefore toxicity. This signal finding Phase I study could point the way to a new treatment paradigm for this intractable brain cancer."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

 
       1. American Association of Neurosurgeons 
        2. Radke et al (2019). Predictive MGMT status in a homogeneous 
        cohort of IDH wildtype glioblastoma patients. Acta Neuropathologica 
        Communications 7:89 Online: https://doi. org/10.1186/s40478-019-0745-z 
 
        For more information, please contact: Midatech Pharma PLC 
         Stephen Stamp, CEO, CFO 
          Dmitry Zamoryakhin, CSO 
         Tel: +44 (0)29 2048 0180 
         www.midatechpharma.com 
 
         Panmure Gordon (UK) Limited (Nominated Adviser and Joint 
          Broker) 
         Freddy Crossley, Emma Earl (Corporate Finance) 
         Rupert Dearden (Corporate Broking) 
         Tel: +44 (0)20 7886 2500 
 
         Turner Pope Investments (TPI) Limited (Joint Broker) 
         Andrew Thacker / James Pope (Corporate Broking) 
          Tel: +44(0)20 3657 0050 
         IFC Advisory Limited (Financial PR and UK Investor Relations) 
         Tim Metcalfe / Graham Herring 
         Tel: +44 (0)20 3934 6630 
         Email: midatech@investor-focus.co.uk 
 
         Edison Group (US Investor Relations) 
          Maxwell Colbert 
          Tel: +1 (646) 653 7028 
          Email: mcolbert@edisongroup.com 
                   About Midatech Pharma PLC 
                    Midatech Pharma PLC (dual listed on LSE AIM: MTPH; and NASDAQ: 
                    MTP) is a drug delivery technology company focused on improving 
                    the bio-delivery and bio-distribution of medicines. The Company 
                    combines approved and development medications with its proprietary 
                    and innovative drug delivery technologies to provide compelling 
                    products that have the potential to powerfully impact the 
                    lives of patients. 
                    The Company has developed three in-house technology platforms, 
                    each with its own unique mechanism to improve delivery of 
                    medications to sites of disease. All of the Company's technologies 
                    have successfully entered human use in the clinic, providing 
                    important validation of the potential for each platform: 
                     *    Q-Sphera(TM) platform: a disruptive micro-technology 
                          used for sustained release to prolong and control the 
                          release of therapeutics over an extended period of 
                          time (from weeks to months). 
 
 
                     *    MidaSolve(TM) platform: an innovative nanotechnology 
                          used to dissolve insoluble drugs so that they can be 
                          administered in liquid form directly and locally into 
                          tumours. 
 
 
                     *    MidaCore(TM) platform: a leading-edge nanotechnology 
                          used for targeting medications to sites of disease. 
 
 
 
                    The platform nature of the technologies offers the potential 
                    to develop multiple drug assets rather than being reliant 
                    on a limited number of programmes. Midatech's technologies 
                    are supported by 36 patent families including 120 granted 
                    patents and an additional 70 patent applications. Midatech's 
                    headquarters and R&D facility is in Cardiff, UK. For more 
                    information please visit www.midatechpharma.com 
 Forward-Looking Statements 
  Certain statements in this press release may constitute "forward-looking 
  statements" within the meaning of legislation in the United 
  Kingdom and/or United States Private Securities Litigation 
  Reform Act. All statements contained in this press release 
  that do not relate to matters of historical fact should be 
  considered forward-looking statements, including, but not 
  limited to, , any payments that may be received, the success 
  of the research collaboration in developing novel products, 
  the strategic review and formal sale process. 
  Reference should be made to those documents that Midatech 
  shall file from time to time or announcements that may be 
  made by Midatech in accordance with the London Stock Exchange 
  AIM Rules for Companies ("AIM Rules"), the Disclosure and 
  Transparency Rules ("DTRs") and the rules and regulations 
  promulgated by the US Securities and Exchange Commission, 
  which contains and identifies other important factors that 
  could cause actual results to differ materially from those 
  contained in any projections or forward-looking statements. 
  These forward-looking statements speak only as of the date 
  of this announcement. All subsequent written and oral forward-looking 
  statements by or concerning Midatech are expressly qualified 
  in their entirety by the cautionary statements above. Except 
  as may be required under the AIM Rules or the DTRs or by relevant 
  law in the United Kingdom or the United States, Midatech does 
  not undertake any obligation to publicly update or revise 
  any forward-looking statements because of new information, 
  future events or otherwise arising. 
 
 

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December 13, 2021 04:42 ET (09:42 GMT)

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