Ahhh, been looking at these guys for over two years now when they 1st called me about working for them. It was slow, but when they got Dick Brewer (old Scios CEO) on the board I knew they were serious.
In May they announced they were 50% done with the major Phase 3 study and that the data cut (for safety) at 25% was perfect. They will now look at the 50% data cut for mortality trends and safety...I would think they will be moving on getting a sales force together in the near future.
They are not public atm but keep an eye on these guys!
Tilarginine Acetate Injection
Arginox's lead compound is Tilarginine Acetate Injection (TAI), a synthetically produced endogenous small molecule that inhibits the production of nitric oxide (NO). The drug is now undergoing clinical evaluation for use in the treatment of heart attack-related cardiogenic shock (CS). Data from a phase II dose-ranging study were presented at the American Heart Assocation meeting in November, 2004. The study found that TAI was well tolerated in the full cohort of patients tested, including those most at risk of dying from CS such as the very old (over age 75) and those with the worst heart function. Although the study was not statistically designed to evaluate mortality, the survival findings were encouraging: Among patients treated with the highest doses of TAI, the death rate was lower than that typically seen in this very sick population.
In May 2005 Arginox launched a single pivotal phase III study to evaluate the effectiveness and safety of TAI for this indication. The 658 patient study, called TRIUMPH (Tilarginine Acetate for Injection in a Randomized International Study in Unstable AMI Patients with Cardiogenic Shock), is the largest study ever in the setting of cardiogenic shock.
In addition, Arginox received Orphan Drug designation for TAI from the FDA.
All those with start up experience, get those resumes ready!
In May they announced they were 50% done with the major Phase 3 study and that the data cut (for safety) at 25% was perfect. They will now look at the 50% data cut for mortality trends and safety...I would think they will be moving on getting a sales force together in the near future.
They are not public atm but keep an eye on these guys!
Tilarginine Acetate Injection
Arginox's lead compound is Tilarginine Acetate Injection (TAI), a synthetically produced endogenous small molecule that inhibits the production of nitric oxide (NO). The drug is now undergoing clinical evaluation for use in the treatment of heart attack-related cardiogenic shock (CS). Data from a phase II dose-ranging study were presented at the American Heart Assocation meeting in November, 2004. The study found that TAI was well tolerated in the full cohort of patients tested, including those most at risk of dying from CS such as the very old (over age 75) and those with the worst heart function. Although the study was not statistically designed to evaluate mortality, the survival findings were encouraging: Among patients treated with the highest doses of TAI, the death rate was lower than that typically seen in this very sick population.
In May 2005 Arginox launched a single pivotal phase III study to evaluate the effectiveness and safety of TAI for this indication. The 658 patient study, called TRIUMPH (Tilarginine Acetate for Injection in a Randomized International Study in Unstable AMI Patients with Cardiogenic Shock), is the largest study ever in the setting of cardiogenic shock.
In addition, Arginox received Orphan Drug designation for TAI from the FDA.
All those with start up experience, get those resumes ready!
