What's ahead
Post# of 30028
LymPro
Sept. 2, 2014 - We are extremely pleased to be working with ICON, and we anticipate completion of the Fit for Purpose Flow Cytometry Assay Validation in the fourth quarter.
Oct. 9, 2014 - Amarantus anticipates completing enrollment of the 68 patient LP-002 extension in the fourth quarter and will announce data from an in-depth analysis from the full cohort of 140 subjects (72 patients + 68 patient extension) shortly thereafter.
Oct. 9, 2014 - Amarantus plans to launch LymPro for RUO in the fourth quarter of 2014, primarily targeting pharmaceutical clinical trials.
Oct. 9, 2014 - The company anticipates launching LymPro under CLIA shortly after product launch in the RUO marketplace.
Eltoprazine
Oct. 27, 2014 - We are looking forward to receiving pre-IND feedback from the FDA later in the fourth quarter and being able to open a new IND in the Neurology Division of FDA shortly thereafter. The Phase 2b trial is on schedule to start in early 2015.
Oct. 27, 2014 - We previously outlined our intentions to initiate a Phase 2b trial for Eltoprazine in Adult ADHD following the initiation of the Phase 2b PD LID clinical trial, and we remain on track to achieve this as much of the groundwork for the Adult ADHD trial is being completed for the Phase 2b PD LID trial.
MANF
Oct. 7, 2014 - These data clearly support our focus on the further development of MANF in orphan ophthalmic indications, such as retinitis pigmentosa and CRVO. We plan to pursue complementary IND pathways in these indications, as well as in glaucoma.
Oct. 27, 2014 - We recently applied to the FDA for orphan drug designation for MANF in Retinitis Pigmentosa and expect additional orphan filings in the near future in the area of ophthalmology.
Oct. 27, 2014 - We expect to initiate GMP manufacturing for MANF this quarter to support multiple IND filings for MANF in various indications.
Company
Oct. 27, 2014 - As a holding company, Amarantus is continuing to evaluate methods of returning value to shareholders, including a potential spinoff of the company’s diagnostic division. In addition to LymPro and our NuroPro Parkinson’s diagnostic, we are actively evaluating additional complementary late-stage neurology-focused diagnostic assets that would bolster our diagnostic division and make for a successful ‘spin-out’ while concurrently returning value to our shareholders. We believe we will be able to execute on this strategy in the near-term.
Oct. 27, 2014 - With this strategy we are insulated from enterprise risk from any one program, thereby giving us leverage as we look for additional product opportunities and allowing us to return value to our long-term shareholders either through equity gains or dividends.