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Midatech Pharma starts dosing in tumour treatment study
Oncology and immunotherapy pharmaceutical firm Midatech Pharma announced on Monday that it has started dosing patients in its first in-human study of sustained release product Q-Octreotide (MTD201).
The study, which is for rare debilitating and often fatal hormone based tumours carcinoid cancer and acromegaly, will evaluate the interchangeability between Q-Octreotide and the reference product, Sandostatin (SLAR) following a single dose administration in 24 patients.
Such equivalency studies are used to establish that the new treatment is not inferior to currently used treatments.
Craig Cook, chief executive designate of Midatech, said: "Having resolved important manufacturing challenges and requirements, and incorporated invaluable regulatory authority feedback into the program design, we are confident that we have a robust study which will provide meaningful data on MTD201 in the second half of this year."
Following the release of data in the second half of the year, the AIM-traded company intends to expand the study to 100 patients in 2019.
Midatech said that it intends to file for US marketing authorisation on a similar label to SLAR the following year and expects that Q-Octreotide will manage to capture 5% of $2bn sales.
"Our 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. We are working hard to bring this product to market to offer patients, physicians and payors an alternative choice for treating these diseases," said Cook.
As of 1255 BST, Midatech Pharma's shares were up 19.3% at 34.00p.
The study, which is for rare debilitating and often fatal hormone based tumours carcinoid cancer and acromegaly, will evaluate the interchangeability between Q-Octreotide and the reference product, Sandostatin (SLAR) following a single dose administration in 24 patients.
Such equivalency studies are used to establish that the new treatment is not inferior to currently used treatments.
Craig Cook, chief executive designate of Midatech, said: "Having resolved important manufacturing challenges and requirements, and incorporated invaluable regulatory authority feedback into the program design, we are confident that we have a robust study which will provide meaningful data on MTD201 in the second half of this year."
Following the release of data in the second half of the year, the AIM-traded company intends to expand the study to 100 patients in 2019.
Midatech said that it intends to file for US marketing authorisation on a similar label to SLAR the following year and expects that Q-Octreotide will manage to capture 5% of $2bn sales.
"Our 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. We are working hard to bring this product to market to offer patients, physicians and payors an alternative choice for treating these diseases," said Cook.
As of 1255 BST, Midatech Pharma's shares were up 19.3% at 34.00p.
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