07:00 , Sep 8, 2014 |  BC Week In Review  |  Clinical News

Aerosolized Alpha-1 antitrypsin: Phase II/III final data

Final data from a double-blind, European and Canadian Phase II/III trial in 168 patients with AAT deficiency showed that twice-daily 160 mg inhaled AAT for 50 weeks missed the secondary endpoints of reducing the time...
07:00 , May 19, 2014 |  BC Week In Review  |  Clinical News

Aerosolized Alpha-1 antitrypsin: Phase II/III data

Top-line data from a double-blind, European and Canadian Phase II/III trial in 168 patients with AAT deficiency showed that twice-daily 160 mg inhaled AAT missed the primary endpoint of improving time to first moderate or...
00:18 , May 17, 2014 |  BC Extra  |  Clinical News

Kamada slides on AAT miss, still planning MAA submission

Kamada Ltd. (Tel Aviv:KMDA; NASDAQ:KMDA) fell $4.74 (34%) to $9.08 in New York on Friday after reporting that twice-daily aerosolized alpha-1 antitrypsin (AAT) missed the primary endpoint in a 168-patient Phase II/III trial to treat...
07:00 , Mar 31, 2014 |  BC Week In Review  |  Clinical News

Aerosolized Alpha-1 antitrypsin: Phase II started

Kamada began a double-blind, placebo-controlled, U.S. Phase II trial to evaluate 80 or 160 mg inhaled AAT twice daily for 12 weeks in 36 patients. Patients will be eligible to enroll in a 12-week, open-label...
08:00 , Dec 3, 2012 |  BC Week In Review  |  Clinical News

Alpha-1 HC Aerosol recombinant alpha-1 proteinase inhibitor regulatory update

The European Commission granted Orphan Drug designation to Grifols' Alpha-1 HC Aerosol to treat cystic fibrosis (CF). The aerosolized formulation of alpha-1 proteinase inhibitor, an alpha 1-antitrypsin ( AAT ) inhibitor of elastase protease, is...
07:00 , Oct 15, 2012 |  BC Week In Review  |  Clinical News

Recombinant Alpha1-Proteinase Inhibitor: Phase II started

Grifols began a double-blind, placebo-controlled, dose-escalation, U.S. Phase II trial to evaluate 100 and 200 mg Alpha-1 HC aerosol daily via nebulizer for 3 weeks in 30 patients. The product has Orphan Drug designation in...
07:00 , May 2, 2011 |  BioCentury  |  Finance

Familiarity breeds content

European life sciences firm LSP raised €36 million ($52.5 million) last week in an IPO for its first in-house fund to invest in public companies. The firm is capitalizing on investors' familiarity with its venture...
08:00 , Feb 21, 2011 |  BC Week In Review  |  Clinical News

Aerosolized Alpha-1 antitrypsin: Interim Phase II/III data

Interim data from a double-blind, placebo-controlled, European Phase II/III trial in patients with emphysema showed that inhaled AAT for 13 months was safe. The product, which uses the eFlow Nebulizer System from Pari, has Orphan...
08:00 , Dec 20, 2010 |  BC Week In Review  |  Clinical News

Prolastin-C: Phase II started

Talecris began the double-blind, crossover, U.S. Phase II SPARK trial to compare 60 and 120 mg/kg doses of weekly IV Prolastin-C for 8 weeks in 30 patients. The 60 mg/kg dose is already approved to...
08:00 , Nov 8, 2010 |  BC Week In Review  |  Company News

Talecris sales and marketing update

Talecris launched Prolastin-C in Canada to treat panacinar emphysema in patients with alpha1-antitrypsin ( AAT ) deficiency. The company said Prolastin-C, which is a more purified and concentrated formulation of its Prolastin alpha proteinase inhibitor,...