08.10.2014 06:51:47

BCLI Gets A Pat On The Back, OXGN At Work, MDGN Rises After Hours

(RTTNews) - BrainStorm Cell Therapeutics Inc. (BCLI) has secured FDA's Fast Track product designation for its core technology, NurOwn, which is currently being studied in a randomized, double-blind, placebo-controlled phase II clinical trial in amyotrophic lateral sclerosis patients.

The NurOwn technology processes adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many other cell types.

BCLI closed Tuesday's trading at $3.98, up 2.84%.

OXiGENE Inc. (OXGN) has enrolled the first patient in a phase 1b/2 clinical study that will evaluate its drug candidate Fosbretabulin in combination with GlaxoSmithKline PLC's (GSK) approved cancer medication Votrient in patients with recurrent ovarian cancer.

The study is estimated to enroll up to 128 patients at sites in the United Kingdom. The primary endpoint is progression-free survival, and secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.

OXGN closed Tuesday's trading 6.88% higher at $2.33.

Medgenics Inc. (MDGN) is all set to present initial data from its ongoing phase 1/2 clinical trial of MDGN-201 at the 22nd Annual Congress of the European Society of Gene and Cell Therapy being held in The Hague, Netherlands from October 23rd-26th, 2014.

The phase 1/2 clinical trial is evaluating the potential of the company's updated BioPump platform to offer sustained production and delivery of erythropoietin (EPO) to treat anemia in dialysis patients with end-stage renal disease (ESRD) or chronic kidney disease (CKD).

MDGN closed Tuesday's trading at $5.86, down 4.72%. In after-hours, the stock gained 15.19% to $6.75.

StemCells Inc. (STEM) has initiated a phase II proof of concept clinical trial using its proprietary HuCNS-SC platform of human neural stem cells for the treatment of cervical spinal cord injury.

By definition, a proof-of-concept study is conducted to provide the first evidence that a candidate drug might be effective for a disease.

The trial, referred to as Pathway Study, will be conducted as a randomized, controlled, single-blind study - with the primary efficacy outcome focusing on change in upper extremity strength as measured in the hands, arms, and shoulders.

STEM closed Tuesday's trading at $1.22, down 3.17%.

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