Protalix Biotherapeutics PLX Stock News

Protalix BioTherapeutics Inc (NYSEAMERICAN: PLX) is making a run for the top in the market this morning, trading on gains of more than 10% before the bell. The company announced positive data from a Phase III clinical trial.

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PLX Stock Runs For The Top On Positive Data

Protalix BioTherapeutics provided strong data from a Phase III clinical trial of PRX-102. The trial, known as the Phase III BRIDGE clinical trial, is assessing PRX-102 as a potential option for patients with Fabry disease.

The clinical trial was a 12 month open-label, single arm switch-over study evaluating the safety and efficacy of the treatment at doses of 1 mg/kg infused every 2 weeks. The treatment was provided to Fabry disease patients that have been previously treated with Replagal for at least two years and on a stable dose for a period of at least six months.

The topline data proved promising.

In the release, PLX said that the treatment resulted in substantial improvement in renal function in both male and female patients who swiched from agalsidase alfa to PRX-102.

The company said that 22 patients were enrolled in the study with two withdrawing early from the study due to hypersansitivity reaction. 20 patients involved successfully treated the 12-month treatment duration.

Moreover, 18 of the 20 patients treated opted to roll over to a long-term extension study and continue being treated with the candidate.

In a statement, Dror Bashan, President and CEO at PLX, had the following to offer:

The completion of our Phase III BRIDGE study and its subsequent analysis mark a significant milestone towards our goal to establish PRX-102 as a new treatment option for Fabry disease. We are encouraged that the BRIDGE study successfully met its main objectives for safety and efficacy, and we are further motivated to continue our work in progressing pegunigalsidase alfa.

Our BRIDGE study, together with our other two ongoing fully enrolled Phase III clinical trials, the BALANCE study and the BRIGHT study, represents what we believe to be the most comprehensive and robust Phase III clinical program for Fabry disease currently in progress. As the first of our three studies to complete Phase III, we believe the BRIDGE study findings support that PRX-102 has the potential to be an important enzyme replacement therapy for the treatment of Fabry disease.

This Is Great News

This is huge news for Protalix BioTherapeutics. Think about it, this is a Phase III clinical trial that resulted in data suggesting that PRX-102 is a better option for Fabry disease patients than the current standard of care.

This is huge, especially when we think about the shear size of the Fabry disease market. In fact, experts expect that the market will grow to be worth more than $3 billion annually.

PLX has a market cap of just over $100 million. Should the company tap into such a large market with a treatment that is proving to be superior to other options in the clinic, the opportunity here could be tremendous, making this a stock that’s hard to ignore.

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