Posts tagged biomarker
3DS completes assay validation for HL

3D Signatures (TSX-V:DXD; OTCQB:TDSGF; FSE:3D0) has successfully completed internal analytical assay validation for its Hodgkin's lymphoma (HL) test (Telo-HL) according to FDA guidelines.

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3DS initiates HL validation program

The validation program for 3D Signatures’ (TSX-V:DXD; OTCQB:TDSGF; FSE:3D0) Hodgkin's lymphoma test (Telo-HL) is under way. Telo-HL is powered by the company's TeloView software platform.

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Can-Fite submits Phase 3 RA trial protocol to EMA

Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) has submitted to the European Medicines Agency (EMA) a protocol design for a Phase 3 trial and registration plan for its lead compound, CF101, in the treatment of rheumatoid arthritis. The company previously had a pre-submission meeting with the EMA.

The global trial is expected to begin in either the second or third quarter of 2016. It will investigate the efficacy and safety of CF101 administered orally twice daily for 16 weeks to patients with active rheumatoid arthritis treated with conventional disease modifying drugs.

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Can-Fite submits Phase 3 protocol for RA study

Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) has submitted its Phase 3 clinical study protocol to the Institutional Review Board of Barzilai Medical Center in Israel and will file similar submissions in several European countries, Canada and the U.S. for a pivotal Phase 3 trial of its lead drug candidate, CF101, in the treatment of rheumatoid arthritis (RA).

The Phase 3 protocol submission in Israel follows a successful meeting that Can-Fite concluded on Dec. 8 with the Medical Products Agency (MPA) in Sweden regarding the European registration of CF101 in the treatment of RA.

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