Final Phase 1 Trial Results Demonstrate Galectin Therapeutics' GR-MD-02 is Safe With Potential for Therapeutic Effect on Fibrosis in NASH Patients With Advanced Fibrosis

NORCROSS, Ga., Jan. 7, 2015  -- Galectin Therapeutics (GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces that final results from its Phase 1 trial show that GR-MD-02 had an effect on a serum biomarker (as assessed by FibroTest(R)) and liver stiffness (as assessed by FibroScan(R)) that suggest a potential for therapeutic effect on fibrosis that warrants further exploration. This first-in-man study, which enrolled 30 patients in three cohorts, principally evaluated the safety, tolerability and pharmacokinetics for single and multiple doses of its galectin-inhibiting drug GR-MD-02 when administered intravenously to patients with fatty liver disease, or nonalcoholic steatohepatitis (NASH) with advanced fibrosis. The study also secondarily examined exploratory biomarkers as well as a newer non-invasive liver stiffness measure. Final Phase 1 data are included in a new corporate presentation which is available on the Company's website (www.galectintherapeutics.com).

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CytRx Announces Positive Interim Phase 2 Aldoxorubicin Results in Glioblastoma Multiforme (Brain Cancer)

Aldoxorubicin Shows a Complete Response, Tumor Shrinkage, Prolonged Stable Disease, and Favorable Tolerability in Patients
Novel Albumin-Binding Drug Candidate Appears to Allow Doxorubicin to Cross the Tumor's Blood-Brain Barrier in Humans

LOS ANGELES, Jan. 6, 2015 -- CytRx Corporation (CYTR), a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer.  The open-label, multisite trial is designed to investigate the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide.  Preliminary results in 12 patients show both prolonged stable disease and tumor shrinkage in several patients, including one patient who demonstrated no microscopic evidence of tumor when tissue was examined after resection, representing a complete response.  These observations suggest that aldoxorubicin allows doxorubicin to cross the tumor's blood-brain barrier in humans.

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Tonix Pharmaceuticals Provides Clinical and Regulatory Update on its Continued Development of TNX-102 SL in Fibromyalgia

Phase 3 Program to Begin in the Second Quarter of 2015

NEW YORK, Jan. 6, 2015  -- Tonix Pharmaceuticals Holding Corp. (TNXP) has received written guidance from the U.S. Food and Drug Administration (FDA) on its Phase 3 clinical study design for TNX-102 SL in fibromyalgia.

"Getting this confirmation from the FDA -- particularly its acceptance of the 30 percent responder analysis as the primary outcome measure -- represents a clear step forward in our ongoing development of TNX-102 SL in fibromyalgia," said Seth Lederman, M.D., president and chief executive officer of Tonix.

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Minerva Neurosciences Reports Positive Data Showing an Analog of Minerva's MIN-301 Compound Improves Symptoms of Parkinson's Disease in Primates

Results provide further support for research involving use of neuregulin-1 compounds in treatment of Parkinson's and other neurodegenerative disorders

WALTHAM, Mass., Jan. 5, 2015 -- Minerva Neurosciences, Inc. (NERV) today announced that results from a Primomed (use of PRIMate MOdels to support translational MEDicine) non-human primate study showed that treatment with an analog of MIN-301, the company's investigational neuregulin-1 compound, resulted in improvements in a range of symptoms associated with Parkinson's disease in primates. MIN-301 is a recombinant form of the neuregulin-1β1 extracellular domain. The analog used in the Primomed study differs from MIN-301 by a single amino acid.

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Protalix BioTherapeutics Announces New Strategy for Accelerated Growth

Prioritizing Pipeline Candidates to Focus on Bio-Better Products With a Clear Competitive Advantage

CARMIEL, Israel, Jan. 5, 2015 -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (PLX.TA), announced today the Company's newly implemented strategy for accelerated growth. The strategy centers around prioritizing existing and new pipeline candidates to focus on bio-better products with potentially clinically superior profiles that offer a clear competitive advantage. The following highlights the details of the strategic plan.

PRX-102 for Fabry disease
PRX-102 is designed to be an improved enzyme replacement therapy product for Fabry disease given its potential for clinically superior outcomes and enhanced safety when compared to currently marketed enzyme replacement therapies.

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