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news.Xenetic Biosciences' license partner Pharmsynthez has completed dosing patients in its Phase II clinical trial with MyeloXen to treat relapsing remitting and secondary progressive (RRSP) multiple sclerosis (MS).
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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.
The trial being conducted in Russia has enrolled a total of 26 patients in three groups.
The first group included single dose of MyeloXen in six healthy volunteers and the drug was well tolerated, while the data allowed progression into the remaining groups.
The second and third groups include patients with RRSP and they were given six multiple escalating doses weekly from 50 up to 900 µg.
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.
Of the 20 patients enrolled, 19 completed 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 to up to 900µg.
According to the company, follow up of all patients and data analysis will complete in the first quarter of 2015.