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news.Midatech Pharma has announced the submission of a clinical trial application (CTA) for a first in human study of its MTD201 programme in carcinoid cancer and acromegaly.
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The Company expects to enter the clinic in Q4 2017, pending the regulatory approval to conduct the clinical trial which is expected shortly.
These indolent and rare hormone tumour diseases cause debilitating morbidity and mortality for patients, and it is anticipated that MTD201 will provide a much-needed addition to the choice of therapies available to patients, physicians, and payors.
MTD201 uses Midatech's innovative sustained release platform to produce a long-acting dose of octreotide, a somatostatin analogue treatment for these tumours being developed as an alternative version of the commercially available product, Sandostatin® LAR (SLAR). The market for octreotide is estimated to be $2bn globally1.
MTD201 is manufactured using Midatech's proprietary Q-Sphera microsphere platform which uses micro-fluidic technology to produce a precision sustained release particle formulation.
The study aims to establish that MTD201 is interchangeable with SLAR pharmacokinetically and/or pharmacodynamically and, by extrapolation, that it will achieve equivalent therapeutic control of growth hormone whilst providing an alternative to SLAR in patients with active acromegaly.
The study is expected to complete in the first half of 2018. The potential benefits of MTD201 versus SLAR include interchangeability, faster and simpler reconstitution with fewer errors and less wastage, reduced pain on injection due to a smaller syringe needle and volume injected, and improved economics.
Dr Jim Phillips, Chief Executive Officer of Midatech Pharma, said: "MTD201 will provide a much-needed addition to currently available therapies for the treatment of carcinoid cancer and acromegaly.
“This clinical trial is the culmination of more than five years of development and is a key value inflection point for our proprietary sustained release technology platform as it moves into the clinic for the first time on track for Q4 2017. We have seen compelling data for MTD201 in pre-clinical models, and we are excited by the potential for this to be evidenced in patients as well."