Date: 2012-11-19
Type of information:
phase: 1-2a
Announcement: initiation of the trial
Company: Xenetic Biosciences (UK)
Product: MyeloXen™
Action
mechanism: MyeloXen™ is a liposomal vaccine being developed in collaboration with Pharmsynthez for the treatment of multiple sclerosis. The active ingredient of MyeloXen is a number of peptides homologous to immunogenic sites of the myelin basic protein. Pre-clinical studies have shown that treatment with this preparation is more effective than with the current gold standard treatment - Copaxone. These studies also demonstrated that Myeloxen has no toxic, anaphylactogenic, allergic, immunotoxic, teratogenic or mutagenic properties and doesn’t adversely affect reproductive function.
Disease: multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country: Russia
Trial
details: The three-part, multicentre, open-label study is being conducted in compliance with Russian regulations under a protocol that includes a total of 26 subjects. The trial will be carried out in three Parts, being:
Part 1: Comprises 6 healthy volunteers
Part 2: Comprises 10 patients for the dose-escalation phase
Part 3: Comprises 10 patients being dosed at the dose levels determined in Part 2.
All six healthy volunteers in Part 1 have now commenced dosing. Patient subjects in Parts 2 and 3 are from groups diagnosed with relapsing, remitting and secondary progressive MS. The end point of the trial is to demonstrate that this novel candidate is safe and well tolerated in patient use; additionally, surrogate efficacy and mechanism of action indicators will be examined.
Latest
news: Xenetic Biosciences, a bio-pharmaceutical company specialising in the development of high-value differentiated biologics and vaccines and novel cancer drugs, has announced the commencement of a Phase I/II(a) human clinical trial of MyeloXen™, its novel vaccine candidate for the treatment of Multiple Sclerosis (MS).
The vaccine has been formulated using the Company\'s patented ImuXen™ liposomal entrapment technology and is one of up to six candidates (including both novel biologic and vaccine candidates) under the Co-Development Agreement (CDA) between Xenetic and Pharmsynthez in St Petersburg.
This trial is externally managed and monitored by OCT in St Petersburg.
