AbbVie Inc. (ABBV) said Tuesday that new data from its phase IIb trial of its investigational direct-acting antivirals, or DAAs, for the treatment of hepatitis C virus infection shows high Sustained Viral Response rates across multiple patient types with HCV Genotype 1.
In the trial, dubbed Aviator Trial, 96 percent of treatment-naive patients and 93 percent of prior null responders treated with AbbVie's investigational IFN-free, triple-DAA combination therapy achieved sustained viral response at 24 weeks or SVR24, the traditional definition of a cure.
ABBV closed Tuesday's trading at $45.14, up 2.13%.
Achillion Pharmaceuticals Inc. (ACHN) presented new data from a phase I study of ACH-3102, which further demonstrated potency of the compound in Genotypes 1a and 1b and against resistant Hepatitis C infection. The study also showed that ACH-3102 and Sovaprevir can be co-administered without interaction. Sovaprevir is another experimental drug of Achillion, currently in phase 2 clinical development and has shown clinical antiviral activity against genotypes 1 and 3.
Acorda Therapeutics Inc. (ACOR) has initiated a phase I trial of rHIgM22, a remyelinating antibody, in people with multiple sclerosis. rHIgM22, discovered at Mayo Clinic, represents a potential new approach to multiple sclerosis treatment.
ACOR touched a new high of $40.87 on Tuesday before closing at $39.22.
Amarin Corp. plc's (AMRN), Supplemental New Drug Application for Vascepa capsules for use as an adjunct to diet in the treatment of adult patients with high triglyceride levels greater than or equal to 200 mg/dL has been accepted by FDA.
Vascepa is already approved by the FDA as an adjunct to diet in the treatment of adult patients with severe hypertriglyceridemia - having triglyceride levels greater than or equal to 500mg/dL.
AMRN closed Tuesday's trading at $6.65, down 2.92%.
Celsion Corp. (CLSN), which took a hit in January of this year, losing over 80% of its stock value, after a phase III trial of its investigational liver cancer treatment ThermoDox failed to meet the primary endpoint of progression free survival, still has hopes on ThermoDox.
In a business update provided on Tuesday the company noted that a comprehensive analysis of the data from the failed phase III study, dubbed the HEAT Study, shows ThermoDox improves progression free survival and overall survival when heating is optimized.
To rein in operating costs to conserve capital, the company has implemented a restructuring program, which includes slashing about one-third of its workforce and the deferral of expenses associated with the phase II study of ThermoDox for the treatment of colorectal liver metastases.
CLSN closed Tuesday's trading 15.03% higher at $0.88.
CEL-SCI Corp (CVM) has hired two new Clinical Research organizations to manage the global phase III trial of its investigational drug Multikine for the treatment of head and neck cancer.
The two new CROs - Aptiv Solutions and Ergomed, will help the company expand the trial by 60-80 clinical sites globally. Ergomed will fund up to $10 million towards the study in exchange for a single digit percentage of milestone and royalty payments.
CVM closed Tuesday's trading at $0.26, down 1.38%.
CytRx Corp. (CYTR) has reached an agreement with FDA on a special protocol assessment for a global pivotal phase III trial with Aldoxorubicin for soft tissue sarcomas. The company said that preparations for the pivotal phase III trial are underway.
CYTR closed Tuesday's trading at $2.80, down 0.71%.
Halozyme Therapeutics Inc. (HALO) has initiated a phase II trial evaluating PEGPH20, a proprietary, investigational drug, as a first-line therapy for patients with stage IV metastatic pancreatic cancer. The study is designed to enroll 124 patients who will receive gemcitabine and nab-paclitaxel either with or without PEGPH20. The primary outcome will be to measure progression-free survival between patients administered PEGPH20 to those who are not.
HALO gained more than 8% on Tuesday to close at $6.54. In the after-hours, the stock was up 4.59% at $6.84.
iBio Inc. (IBIO) has offered to sell 8.925 units at a price of $0.48 per unit in an underwritten public offering. The company expects to raise gross proceeds of approximately $4.28 million in the offering. The transaction is expected to close on or about April 26, 2013.
IBIO shed 13.54% to close Tuesday's trading at $0.42.
InspireMD Inc. (NSPR) has received approval from FDA to begin regulatory trial for its MGuard EPS coronary stent system in the U.S. MGuard EPS is CE Mark approved, but is not approved for sale in the U.S.
The multi-center, randomized trial, dubbed MASTER II IDE trial, will consist of 1,114 patients suffering from ST Elevation Myocardial Infarction, throughout 35 sites in the U.S. and an additional 35 sites in Europe.
NSPR rose 4.32% to close Tuesday's trading at $2.05.
Isis Pharmaceuticals Inc. (ISIS) has initiated a phase II study of ISIS-SMNRx in infants with spinal muscular atrophy, and the study is expected to begin enrolling patients soon. Isis will earn a $3.5 million milestone payment from Biogen Idec, its collaboration partner for ISIS-SMNRx, when the first infant is dosed in the study, which is projected for May 2013.
ISIS touched a new high of $22.30 on Tuesday before closing at $22.16.
Prothena Corp. plc (PRTA) said Tuesday that the first patient has been dosed successfully in a phase 1 clinical trial of its antibody therapeutic candidate, NEOD001, which is evaluating its safety and tolerability in patients with AL amyloidosis.
AL amyloidosis or primary amyloidosis is a hematological disorder caused by tissue deposition of misfolded proteins that result in progressive organ damage.
PRTA closed Tuesday's trading at $8, unchanged from the previous day's price.
Sanofi Pasteur, the vaccines division of Sanofi (SNY) announced that its novel biologic candidate for Pseudomonas aeruginosa, KB001A, has been granted fast track designation. KB001A is currently under a phase I trial in the United States, and Sanofi has started the planning of a phase IIb study.
KB001-A was licensed from KaloBios Pharmaceuticals (KBIO) by Sanofi Pasteur in 2010 for the treatment of Pseudomonas aeruginosa-related hospital-acquired infections.
SNY touched a new high of $54.55 on Tuesday before closing at $54.28.
The FDA has approved the expanded use of Sucampo Pharmaceuticals Inc.'s (SCMP) AMITIZA for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.
AMITIZA is already approved in the U.S. for the treatment of chronic idiopathic constipation in adults and irritable bowel syndrome with constipation in adult women.
SCMP touched a new 52-week high of $8.55 on Tuesday before closing at $8.46.
Tranzyme Inc. (TZYM) has signed an agreement with privately held Ocera Therapeutics Inc., under which Ocera will merge with a subsidiary of Tranzyme in an all-stock transaction. Upon closing, the company will be named Ocera Therapeutics Inc., a NASDAQ-listed company. Ocera's lead clinical program, OCR-002, a differentiated product candidate for orphan liver diseases, is expected to advance into phase 2b trial later this year with additional phase 2a data anticipated in 2014.
TZYM closed Tuesday's trading at $0.52, down 5.35%.
Teva Pharmaceutical Industries Ltd. (TEVA) said the investigational phase II drug XEN402 being developed for the treatment of pain associated with erythromelalgia has been granted orphan-drug designation by the FDA.
XEN402 was licensed from Xenon Pharmaceuticals Inc. by Teva last December.
TEVA closed Tuesday's trading at $37.87, down 0.03%.
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