Corbus Pharmaceuticals Receives Orphan Designation for Resunab for the Treatment of Cystic Fibrosis in the European Union

NORWOOD, MA--( October 18, 2016) - Corbus Pharmaceuticals Holdings, Inc. (CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced today that the European Commission has granted Orphan Designation in the European Union for the Company's novel synthetic oral endocannabinoid-mimetic drug, Resunab, for the treatment of cystic fibrosis ("CF").
 
The Company previously announced that Resunab was granted Orphan Drug Designation and Fast Track status for the treatment of CF and the treatment of systemic sclerosis in the U.S. by the Food and Drug Administration ("FDA"). Resunab is currently being evaluated in three Phase 2 trials in CF, systemic sclerosis, and dermatomyositis, respectively. A fourth National Institutes of Health-sponsored clinical study of Resunab insystemic lupus erythematosus is planned to begin in the first quarter of 2017.
 
"Receiving Orphan Designation for Resunab in the treatment of CF in the European Union is a noteworthy milestone in our global regulatory strategy for the clinical development of Resunab in CF," stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company.
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Cannabix Technologies Develops Beta 2.0 Marijuana Breathalyzer 

Cannabix Technologies Inc. (CSE:BLO)(CSE:BLO.CN)(OTC PINK:BLOZF) (the "Company") provides an update on the development of its FAIMS (high-field asymmetric waveform ion mobility spectrometry) based instrument for detection of trace amounts of tetrahydrocannabinol ("THC") from exhaled breath at the roadside and in the workplace. The Company is pleased to report that it has developed a "Beta 2.0" (Cannabix Marijuana Breathalyzer) device with major advances in the design and size of the device, including: greater sensitivity, improved performance by the square waveform generator. The current design includes features to allow for the addition of a rechargeable battery and touch screen and the device is approximately 10 times smaller than the Beta 1.0 device announced in July. Preliminary lab tests of the FAIMS device coupled with quadrupole ion trap mass spectrometry have shown lower levels of detection for THC standards than were achieved in past testing.
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Ritter Pharmaceuticals Concludes Last Patient Visit of Its Phase 2b/3 Clinical Trial of RP-G28 for the Treatment of Lactose Intolerance

LOS ANGELES, CA--(Oct 17, 2016) - Ritter Pharmaceuticals, Inc. (NASDAQ : RTTR ) ("Ritter Pharmaceuticals" or the "Company"), a pharmaceutical company developing novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, today announced that the last patient has completed dosing and all monitoring visits in its Phase 2b/3 clinical trial of RP-G28 for the treatment of lactose intolerance. Topline results of the trial are expected to be announced in the first quarter of 2017.
 
Andrew J. Ritter, Co-Founder and President of Ritter Pharmaceuticals stated, "We are pleased to have met our timeline and concluded the dosing of our investigational drug in 377 patients. This significant milestone brings us one step closer to data read-out and reporting. Considering the enormous population of over 40 million individuals in the United States that suffer from lactose intolerance and the lack of sufficient treatment options, we are eager to establish our therapeutic product as potentially the first FDA-approved treatment for this condition."
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CMX157 Advances Head-to-Head Phase 2a Clinical Study in Hepatitis B Patients with Favorable Recommendation from DSMB

EDISON, N.J., Oct. 17, 2016  -- ContraVir Pharmaceuticals, Inc. (CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that following a positive recommendation from an independent Data Safety Monitoring Board (DSMB), the company has begun enrolling the next dosing group in its head-to-head Phase 2a dose-escalation study comparing the safety and efficacy of ContraVir's CMX157 to tenofovir disoproxil fumarate (TDF, marketed by Gilead Sciences as Viread®) in patients with chronic hepatitis B (HBV). ContraVir expects to complete the remaining two escalation cohorts and report top-line results by year-end 2016.
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Omeros Announces Positive Data from OMS721 Phase 2 Clinical Trial in Renal Diseases

SEATTLE-- Omeros Corporation (OMER) today announced positive data from the company’s Phase 2 clinical trial of OMS721 for the treatment of kidney disorders, none of which currently have an approved treatment and all of which frequently lead to end-stage renal disease and dialysis. Statistical significance (p ≤ 0.017) was achieved on key endpoints of improvement in renal function. Omeros also reported the outcome of a recent FDA meeting regarding breakthrough therapy designation for OMS721 in immunoglobulin A (IgA) nephropathy (also known as Berger’s disease). Based on that meeting, Omeros is pursuing FDA breakthrough therapy designation. In addition to the Phase 2 program in renal diseases, OMS721 is being evaluated in a Phase 3 program for patients with atypical hemolytic uremic syndrome (aHUS) and in a Phase 2 program for patients with thrombotic microangiopathies (TMAs), including hematopoietic stem cell transplant-associated TMAs and thrombotic thrombocytopenic purpura. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.
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