Experimental Drug for RRMS, SPMS Enters Phase 2 Trial

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by Patricia Silva, PhD |

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Xenetic BiosciencesLexington, MA-based biopharmaceutical company Xenetic Biosciences, Inc. has just announced its new license partner Pharmsynthez has completed dosing in its ongoing Phase 2 clinical trial with pipeline product MyeloXen™ for relapsing remitting and secondary progressive (SPMS) multiple sclerosis.

The MyeloXen trial is currently underway in Russia with 26 patients divided into 3 groups. The first group includes 6 healthy participants who received a single dose of the drug and were reported last year to have tolerated it well. The results from this cohort prompted dosing in two more groups. The 2nd and 3rd groups enrolled patients with relapsing remitting or secondary progressive MS with a determined Expanded Disability Status Scale (EDSS) of ≥3.0 and ≤5.5, who had experienced at least one exacerbation in the past year, and who had an unsuccessful treatment response to prior immunomodulation and/or immunosuppression therapy.

The patients received 6 increasing doses every week, beginning with 50μg up to 900μg. 15 patients completed the study and the follow up period, and exhibited good tolerance of multiple doses of MyeloXen up to 900μg. Additional follow up data is expected to be ready within Q1 2015.

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M. Scott Maguire, the chief executive officer of Xenetic Biosciences, said that the results gathered from the dose-escalation study on MyeloXen proved quite promising, and should serve as reliable groundwork for the continuing efforts of the company’s license partner Pharmsynthez. “Our company’s business strategy is to de-risk drug development by utilizing 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 U.S.”

Maguire added that Xenetic currently has 12 novel pipeline products outlicensed in Russia and India. One of these is ErepoXen®, an improved, polysialylated form of erythropoietin indicated for anemia in pre-dialysis patients living with chronic kidney disease. This product is currently undergoing a Phase 2 trial in Australia and New Zealand. Another leading pipeline product from Xenetic is OncoHist®, a recombinant human histone H1.3 molecule for refractory acute myeloid leukemia, which is about to be studied in a Phase 2a clinical trial in the US in 2015.

Xenetic has successfully gathered clinical findings on 6 drugs and vaccines, indicated for 8 diseases. The company is expecting to add more clinical information from other ongoing research programs by the end of 2014.

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