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Midatech Pharma starts dosing of sustained release tumour treatment in equivalence study

Published: 17:29 21 May 2018 AEST

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A clinical equivalence study will be carried out in 24 healthy people

Midatech Pharma PLC (LON:MTPH Nasdaq:MTP) has started dosing patients in its first in-human study of sustained release product Q-Octreotide (MTD201).

The study is for carcinoid cancer and acromegaly, two rare, debilitating and often fatal hormone-based tumours.

READ: Midatech Pharma primed and funded for success

A clinical equivalence study in 24 healthy people will evaluate the interchangeability between Q-Octreotide and the reference product, Sandostatin (SLAR) following single dose administration.

Equivalence studies are used to establish a treatment is no worse than the current standard or care.

Midatech wants to demonstrate that Q-Octreotide can achieve safe and effective growth hormone levels while also highlighting the advantages of its release system over SLAR.

Data from the equivalence study is expected in the second half of 2018 with the intention to expand the number of subjects to 100 in 2019.

If the studies are successful, Midatech intends to file for US marketing authorisation in 2020 on a similar label to SLAR and sees Q-Octreotide capturing 5% of US$2bn sales.

Craig Cook, Midatech's CEO-designate, said: "Having resolved important manufacturing challenges and requirements and incorporated invaluable regulatory authority feedback into the programme design, we are confident that we have a robust study which will provide meaningful data on MTD201 in the second half of this year. 

“Pre-clinical data so far illustrates the interchangeability as well as numerous benefits of Q-Octreotide as a therapy for the debilitating and lethal diseases of carcinoid cancer and acromegaly versus the standard of care.”

 

 

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