US-based biopharmaceutical firm Xenetic Biosciences’ licence partner Pharmsynthez has completed dosing in its Phase II clinical trial with MyeloXen in patients with relapsing remitting and secondary progressive (RRSP) multiple sclerosis (MS).
The new vaccine uses the ImuXen Technology based on the concept of simultaneous delivery of multiple active pharmaceutical ingredients (APIs) as antigens within the same liposome.
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A total of 26 patients in three groups have been enrolled in the trial, which is being conducted in Russia.
The first group included single dose of MyeloXen in six healthy volunteers and the drug was well tolerated and the data allowed progression into the remaining cohorts.
The second and third groups include patients with RRSP and they were given six multiple escalating doses weekly from 50µg to 900µg.
These groups included RRSP patients with Expanded Disability Status Scale (EDSS) of =3.0 and =5.5, not less than one attack during the previous year and failure of previous immunomodulation and/or immunosuppression therapy.
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By GlobalDataOf the 20 patients enrolled, 19 finished the trial, while 15 of the 19 patients who completed the trial have completed the follow up period.
The trial showed that MyeloXen was well tolerated at multiple doses up to 900µg.
According to the company, follow up of all patients and data analysis will be complete in the first quarter of 2015.
Xenetic Biosciences chief executive officer Scott Maguire said: "Early data in this dose-escalation study on a novel vaccine for MS are promising and we look forward to Pharmsynthez completing the study and providing us with additional data on this study.
"Our company’s business strategy is to de-risk drug development by utilising clinical data generated by our partners in Russia and India- who are also our shareholders- before advancing these clinically vetted drug candidates into clinical trials in the US.
"We currently have 12 drug candidates outlicensed to our Russian and Indian partners, which provides a potentially significant pipeline for the company.
The company’s product pipeline includes ErepoXen, which is currently in a Phase II trial in Australia and New Zealand with potential benefits over current marketed erythropoiesis-stimulating agents.
Currently, the company is planning to start a Phase IIa trial of its product OncoHist, in the US in the first half of 2015, as a treatment for acute myeloid leukaemia as well as another undisclosed orphan cancer indication.
Image: Photomicrograph of a demyelinating multiple sclerosis-Lesion. Photo: courtesy of Marvin 101.
