AGIO At New High, TRIV Applauded, FDA Approves 2 Drugs For IPF, INSY Falls

(RTTNews) - Advaxis Inc. (ADXS) said that preliminary data from its phase 1/2 study of ADXS-HPV in human papillomavirus associated anal cancer indicate a "clinical complete response" in all 7 patients who have completed the treatment regimen.

The phase 1/2 trial is designed to enroll 25 patients to determine the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer in patients who have a high risk of recurrence based on their disease.

ADXS closed Wednesday's trading at $2.76, up 7.81%.

Agios Pharmaceuticals Inc. (AGIO) has initiated four expansion cohorts in its ongoing phase 1 study of AG-221 at 100 mg once daily in approximately 100 patients with IDH2-mutant hematologic malignancies, including acute myelogenous leukemia.

The company is scheduled to present data from its phase 1 study investigating AG-120 in IDH1-mutant cancers in November.

AGIO touched a new high of $69.98 on Wednesday before closing the day's trading at $65.23.

The FDA on Wednesday approved Esbriet, known chemically as pirfenidone, for the treatment of Idiopathic Pulmonary Fibrosis in the United States, well ahead of the decision date of Nov. 23, 2014.

Idiopathic pulmonary fibrosis, or IPF, is a condition in which the lungs become progressively scarred over time, with patients experiencing shortness of breath, cough, and difficulty in participating in everyday physical activities.

Esbriet, developed by InterMune, was approved in the European Union in 2011 for the treatment of adults with mild to moderate IPF in all 28 EU member countries, and has since been approved in Norway, Iceland and Canada. InterMune was acquired by Roche Holding AG (RHHBY.OB)for $8.3 billion in August of this year.

Another drug to win FDA approval for IPF on Wednesday is Boehringer Ingelheim Pharmaceuticals Inc.'s Ofev (Nintedanib). This drug has also been approved ahead of the decision date of Jan. 2, 2015.

The FDA has refused to file Insys Therapeutics Inc.'s (INSY) New Drug Application for Dronabinol Oral Solution stating that the pediatric study plan in its submission is an inadequate or incomplete to permit a substantive review.

Insys is seeking approval for Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy (CINV) in patients who have failed to respond adequately to conventional antiemetic treatments.

INSY closed Wednesday's trading 6.54% higher at $37.28. In after hours, the stock lost 8.80% and was at $34.

Tekmira Pharmaceuticals Corp. (TKMR) (TKM.TO) announced that its investigational drug TKM-HBV, a therapeutic agent targeting human hepatitis B virus, has demonstrated potent and rapid reduction in hepatitis B surface antigen in several preclinical models including the chronically infected humanized (chimeric) mouse.

The company plans to move TKM-HBV to clinical testing in early 2015.

TKMR closed Wednesday's trading at $23.90, up 1.27%.

TriVascular Technologies Inc. (TRIV) announced Wednesday that the FDA has approved CustomSeal Technology for its Ovation Prime System, a minimally invasive device treatment for abdominal aortic aneurysm.

According to the company, the CustomSeal Technology enables faster procedure times through a 30% reduction in cure time.

The original Ovation system received CE Mark clearance in August 2010 and FDA approval in October 2012. An improved version of the device - Ovation Prime system was approved by FDA in January 2013.

TRIV closed Wednesday's trading at $15.79, up 13.43%.