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PJSC Pharmsynthez Completes Follow Up and Data Analysis From a Phase 2 Study of Novel Therapeutic Vaccine Xemys(TM) for MS


PJSC Pharmsynthez (LIFE.ME), a St. Petersburg, Russia based pharmaceutical company developing next generation vaccines and biologics has completed follow up and data analysis from a first-in-human, proof-of-concept and dose-escalation study of CD206-targeted proprietary liposomal oligopeptides in multiple sclerosis (MS) patients who are resistant to first-line disease modifying therapies. Xemys™ uses Xenetic Biosciences (XBIO) patented ImuXen™ technology.

In a phase IIA open-label dose-escalating study, a total of 20 patients with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) were subcutaneously injected weekly for six weeks with ascending doses of Xemys™ up to a total dose of 2.675 mg. Patients included in the study had experienced significant disease activity despite interferon-beta (IFN-b) or glatiramer acetate (GA) treatment, with 34 relapses during a one-year period prior to inclusion into the study.

Clinical evaluations, including expanded disability scale score (EDSS), magnetic resonance imaging (MRI), and serum cytokine levels were conducted before the first injection, during the six-week treatment period, and up to 17 weeks after the final injection. The level of EDSS, amounts of T2-w lesions and new gadolinium-enhancing lesions based on MRI were statistically unchanged at the study exit. Levels of serum cytokines MCP-1, MIP-1, and IL-7 decreased, whereas the level of TNF increased during treatment.

In this study, subcutaneous administration of Xemys™ was well tolerated in MS patients who had previously failed to achieve sustained disease control with glatiramer acetate (GA) or IFN-b. The adverse events related to Xemys™ were of mild or moderate severity and occurred mainly with submaximal and maximal doses of Xemys™. Adverse events required no concomitant medication and did not cause abnormalities in blood tests or other safety measures. Notably, at 20 weeks after inclusion to the study, 7 patients (37%) showed no evidence of disease activity as assessed by NEDA (No Evidence of Disease) scoring, and 16 patients (85%) were relapse-free with only 3 relapsing patients during whole study period. Statistically significant increases in the number of Gadolinium-enhancing lesions were apparent only within the small group of patients who experienced relapse.

About Xenetic Biosciences

Xenetic Biosciences, Inc. is a biopharmaceutical company developing next-generation biologic drugs and novel oncology therapeutics. Xenetic's proprietary drug technology platforms include PolyXen®, designed to develop next generation biologic drugs by enhancing activity and half-life through conjugation with polysialic acid (PSA).

Xenetic's lead product candidates include ErepoXen™, a polysialylated form of erythropoietin (EPO) for the treatment of anemia in pre-dialysis patients with chronic kidney disease, and development-stage oncology therapeutics Virexxa™ and OncoHist™, which have FDA orphan designations for the treatment of progesterone receptor negative endometrial cancer and refractory acute myeloid leukemia, respectively.

Xenetic is also working together with Baxalta Incorporated (formerly Baxter Healthcare) to develop a novel series of polysialylated blood coagulation factors, including a next generation Factor VIII. This collaboration relies on Xenetic's PolyXen technology to conjugate PSA to therapeutic blood-clotting factors, with the goal of improving the pharmacokinetic profile and extending the active life of these biologic molecules. The agreement is an exclusive research, development and license agreement which grants Baxalta a worldwide, exclusive, royalty-bearing license to Xenetic's PSA patented and proprietary technology in combination with Baxalta's proprietary molecules designed for the treatment of blood and bleeding disorders. Under the agreement, Xenetic may receive regulatory and sales target payments for total potential milestone receipts of up to $100 million plus royalties on sales. Baxalta is one of the Company's largest shareholders, having invested $10M in the common stock of the Company during 2014. Xenetic has also received strategic investments from OPKO Health (OPK) and is collaborating with Russian-based PJSC Pharmsynthez (an affiliate of a significant shareholder in Xenetic).

Story Source: The above story is based on materials provided by PIPELINEREVIEW
Note: Materials may be edited for content and length


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