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10/26/2016 12:33:33 AM
10/26/2016 12:33:33 AM UTC-0400

OGXI Up On Phase II Results, DPRX Falters On Missed Steps, LXRX Awaits Dec Data

(RTTNews) - AmpliPhi Biosciences Corp. (APHB) has reported favorable topline safety and tolerability results from its phase I trial of AB-SA01 in patients suffering from chronic rhinosinusitis.

Initiated in January 2016, the trial has enrolled 9 patients. The company noted that the Safety Monitoring Committee overseeing the trial has determined that AB-SA01 was well-tolerated by all nine patients and that there were no drug-related serious adverse events.

APHB closed Tuesday's trading at $1.14, down 2.56%.

Shares of Dipexium Pharmaceuticals Inc. (DPRX) slumped 78% on Tuesday on failure of two phase III trials of its investigational product of Locilex in patients with mild infections of diabetic foot ulcers.

The two trials of Locilex, dubbed OneStep-1 and OneStep-2, did not meet the primary clinical endpoint of superiority versus vehicle plus standardized wound care and also did not show any meaningful difference in wound closure rate between the Locilex arm and the vehicle arm in each study.

The trials also failed the secondary endpoint of demonstrating a higher rate of eradication of bacteria for the Locilex arm.

DPRX closed Tuesday's trading at $2.80, down 78.04%.

Lexicon Pharmaceuticals Inc.'s (LXRX) phase II clinical trial of Sotagliflozin in patients with type 1 diabetes has met its primary endpoint, dubbed inTandem4, showing a statistically significant reduction in A1C at 12 weeks.

A second pivotal phase III clinical trial of Sotagliflozin, known as inTandem2, is underway, with top-line results expected in December 2016. The company reported positive top-line results from its first pivotal phase III trial of Sotagliflozin, dubbed inTandem1, on September 9, 2016, sending the stock up over 16% that day.

LXRX closed Tuesday's trading at $15.86, up 0.70%.

Shares of OncoGenex Pharmaceuticals Inc. (OGXI) were up over 29% in extended trading on Tuesday, following positive survival results from a phase II trial of Apatorsen in metastatic bladder cancer.

In the trial, dubbed Borealis-2, patients were randomized to receive Apatorsen in combination with Docetaxel treatment or Docetaxel treatment alone.

According to the trial results, patients who received Apatorsen treatment experienced a 20% reduction in risk of death, compared to patients receiving Docetaxel alone.

OGXI closed Tuesday's trading at $0.37, up 0.11%. In after-hours, the stock was up 29.55% to $0.48.

Portola Pharmaceuticals Inc. (PTLA) has submitted a New Drug Application to the FDA seeking approval to market Betrixaban for extended-duration prophylaxis of venous thromboembolism in acute medically ill patients.

Whether or not, the FDA accepts the NDA for review will be known within 60 days.

The company plans to submit a Marketing Authorization Application for approval of Betrixaban in the EU by the end of this year.

Betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant that directly inhibits the activity of Factor Xa that plays a key role in the blood coagulation.

PTLA closed Tuesday's trading at $19.76, up 1.33%.

Vertex Pharmaceuticals Inc. (VRTX) expects to start two phase II studies to evaluate VX-440 and VX-152 in triple combination regimens with tezacaftor (VX-661) and ivacaftor in people with cystic fibrosis by the end of 2016.

The phase II study of VX-440 is designed to evaluate the safety and efficacy of 4-week dosing of VX-440 in combination with tezacaftor and ivacaftor in approximately 40 people with CF who have one F508del mutation and one minimal function mutation and approximately 25 people with two copies of the F508del mutation.

The phase II study of VX-152 will evaluate 2 weeks of triple combination dosing in approximately 35 people with CF who have one F508del mutation and one minimal function mutation and approximately 25 people with two copies of the F508del mutation.

Data from both the studies are expected in the second half of 2017.

VRTX closed Tuesday's trading at $78.71, down 0.03%. In after hours, the stock was up 6.23% to $83.61.

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