SAN FRANCISCO and GENEVA, Aug. 17, 2015 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, announced financial results for the second quarter ended June 30, 2015. The Company also highlighted recent corporate and clinical development achievements for its Therapeutics Division and its wholly-owned subsidiary, Amarantus Diagnostics, Inc.
SECOND QUARTER 2015 AND RECENT HIGHLIGHTS
Corporate
- Commenced trading on the OTCQX Marketplace as part of the path to progress to a national stock exchange listing;
- Completed a capital restructuring in order to meet share price requirements in preparation for a national exchange listing
Amarantus Therapeutics
- Engineered Skin Subsitute (ESS): Autologous full thickness skin replacement product for severe burns
- Signed a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research and Rutgers, The State University of New Jersey to expand the development of ESS for the treatment of deep partial- and full-thickness burn wounds in adult patients (ClinicalTrials.gov Identifier: NCT01655407);
- Completed the acquisition of Cutanogen Corporation from Lonza Walkersville, Inc. (Lonza), a subsidiary of Lonza Group Ltd., thereby securing full ownership and exclusive worldwide license to intellectual property rights associated with ESS; and
- Engaged Lonza via a long-term services agreement to manufacture ESS under Good Manufacturing Practices for human clinical trials, and subsequent commercial distribution.
- Eltoprazine: Parkinson’s disease levodopa-induced dyskinesia (PD-LID), adult ADHD, and Alzheimer’s aggression
- Commenced enrollment and initiated dosing in the Phase 2b multi-center, 60-subject, double-blind, placebo-controlled, four-way crossover, dose range finding clinical study for the treatment of PD-LID (ClinicalTrials.gov Identifier: NCT02439125);
- Announced the publication of data on long-term efficacy and elucidating the mechanism of action of eltoprazine in an animal model of PD-LID;
- Announced the issuance of the U.S. patent covering proprietary methods of administration for eltoprazine for the treatment of Parkinson’s disease;
- Presented data from the Phase 1/2a clinical study of eltoprazine in PD-LID at the 19th International Congress of Parkinson’s Disease and Movement Disorders; and
- Completed Phase 2b clinical investigator meetings in both the United States and European Union.
- MANF: Mesencephalic-astrocyte-derived neurotrophic factor
- Announced the successful delivery and distribution of MANF in a preclinical model to brain areas involved in Parkinson’s disease, further solidifying the rationale for its development as a potential disease-modifying treatment for PD;
- Entered into a cGMP manufacturing agreement with Catalent Biologics for clinical-grade production of MANF to enable program advancement into human clinical studies in retinitis pigmentosa (RP), retinal artery occlusion and Parkinson’s disease;
- Presented positive preclinical data showing MANF preserves the light-sensing function of photoreceptor cells at the leading ophthalmology conference ARVO 2015;
- Received a Notice of Allowance for the U.S. patent application covering compositions of matter and methods of use related to proprietary manufacturing processes for synthetic MANF and its administration for protein therapy and cell therapy; and
- Received European Union Orphan Drug Designation (ODD) for MANF for the treatment of RP, complementing the U.S. ODD obtained in December 2014.
“The completion of the acquisition of Cutanogen from Lonza this quarter is a significant milestone for Amarantus Therapeutics. ESS is a potentially revolutionary solution for the treatment of severe burns that has demonstrated initial human proof-of-concept in an investigator-initiated setting,” commented Joseph Rubinfeld, Ph.D., member of the Amarantus Board Directors. “Our collaboration with the U.S. Army is an important part of the expansion plan for the clinical development program of ESS. We expect to focus on the regulatory strategy for ESS in the weeks ahead.”
Amarantus Diagnostics, Inc. (a wholly owned subsidiary of Amarantus BioScience Holdings, Inc.)
- Established a Strategic Advisory Committee for Amarantus Diagnostics comprising three seasoned, results-driven life science and healthcare industry leaders with expertise in commercializing molecular diagnostics to focus on advancing and deriving the full value of the company’s diagnostics business.
- LymPro Test® for the diagnosis of Alzheimer’s disease (AD)
- Presented data demonstrating that LymPro met primary and secondary endpoints in the blinded, multi-center LP-002 clinical study that confirms LymPro’s Fit-For-Purpose use in AD Clinical Trials at the 2015 Alzheimer’s Association International Conference®; and
- Advanced business development activities with the pharmaceutical industry for Investigational Use Only (IUO) LymPro Test biomarker services.
- MSPrecise® for the diagnosis of multiple sclerosis (MS)
- Published data in the Journal GENE from a clinical study demonstrating that MSPrecise supports identification of multiple sclerosis patients with 84% accuracy and performs well in identifying MS among a broad cohort of potential neurological diseases; and
- Reported preliminary data from a blood-based version of MSPrecise showing it has statistically significant sensitivity and specificity for classifying presentation of MS.
- Georgetown Assays for the diagnosis of AD
- Continued to explore the potential of the emerging AD IUO blood diagnostics market through the one-year, exclusive option agreement with Georgetown University to license patent rights for blood based biomarkers for AD and memory loss.
“The addition of ESS to our product portfolio adds a first-in-class regenerative medicine platform to our pipeline. The advancement of Eltoprazine into Phase 2b clinical development represents a significant achievement as we establish clinical and regulatory excellence at Amarantus Therapeutics,” added David A. Lowe, Ph.D., member of the Amarantus Board of Directors. “As we round out 2015 we expect to see additional momentum in our strategy for Amarantus Diagnostics under the guidance of our newly appointed Strategic Advisory Committee tasked with realizing the full value from our neuro-diagnostics business.”
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