Posts tagged clinical study
Theralase researcher discovers potent anti-cancer drugs

Theralase Technologies (OTCQX:TLTFF; TSXV:TLT) recently identified a new platform of super potent anti-cancer drugs, or PDCs, discovered by Dr. Sherri McFarland, Professor, Department of Chemistry and Biochemistry, University of North Carolina at Greensboro, the original inventor of the Theralase licensed ruthenium-based PDCs.

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Tetra in cannabis pact with Constance Therapeutics

Tetra Bio-Pharma (OTCQB:TBPMF; CSE:TBP) has signed a letter of intent with Constance Therapeutics of San Francisco for the clinical development and commercialization in Canada of its signature medicinal cannabis extract products.

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Histogenics pathway for NeoCart cleared in Japan

Histogenics (NASDAQ:HSGX) has successfully completed all formal consultations with the Office of Cellular and Tissue-based Products of the Japan Pharmaceuticals and Medical Devices Agency (PMDA) regarding the marketing and manufacturing authorization pathway for its NeoCart autologous cell therapy to treat cartilage defects in the knee in the Japanese market. 

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RepliCel hair loss trial meets primary endpoints

RepliCel Life Sciences (OTCQB:REPCF; TSXV:RP; FRA:P6P2) has successfully completed its first-in-human clinical study of the company's autologous cell therapy for the treatment of androgenetic alopecia (pattern baldness).

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BioLight’s CellDetect posts positive results in prostate cancer

BioLight Life Sciences (TASE:BOLT) reported promising results from a feasibility clinical study designed to detect prostate cancer cells in urine specimens using its CellDetect technology.

The study successfully demonstrated the feasibility of detecting intact cells originating in the prostate from urine samples following prostate massage.

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Anavex gets orphan drug status in Rett syndrome

The FDA has granted orphan drug designation to Anavex Life Sciences’ (NASDAQ:AVXL) ANAVEX 2-73 for the treatment of Rett syndrome.

In a statement, Christopher Missling, president and CEO, said orphan drug designation marks the first U.S. movement for ANAVEX 2-73.

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BioSight completes Phase 1/2a leukemia trial

Closely-held BioSight has completed patient treatment in its ongoing Phase 1/2a clinical study of Astarabine in acute leukemia patients and expects to report final results in coming months.

The Phase 1/2a trial is an open-label study to evaluate the safety and efficacy of Astarabine as single agent in adults with acute myeloid leukemia (AML) and relapsed/refractory acute lymphoblastic leukemia (ALL).

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Titan Pharma receives FDA feedback on Parkinson’s implant

The FDA has provided written feedback to Titan Pharmaceuticals (NASDAQ:TTNP) on the initial development plan for its proprietary ropinirole hydrochloride implant for Parkinson’s disease.

Based on the FDA’s feedback on the development plan submitted in December 2015, Titan is proceeding with the required non-clinical studies to support a potential IND submission in the fourth quarter of 2016, followed by an initial pharmacokinetic and proof-of-concept clinical study. Titan is pursuing a 505(b)(2) registration pathway for the implant.

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BioLight reports positive TeaRx test results for DES

BioLight Israeli Life Sciences Investments (OTCQX: BLGTY; TASE: BOLT) has completed a second successful U.S. clinical study to assess the effectiveness of its TeaRx multi-assay test in evaluating tears’ components of healthy subjects as well as of patients suffering from dry eye syndrome (DES).

The study, conducted by development partner Ora Inc., enrolled 74 subjects in the U.S. All study subjects were evaluated using a composite of four established benchmark tests for the assessment of DES, used in previous FDA regulatory approval processes for other DES products, to define and distinguish populations of healthy subjects from those with different grades of DES.

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