Knobias Clip Report (02-19-2008)
Submitted By Knobias ClipReport
ADLS: CEO Discusses Positive QT Study and Development of Cethromycin
Advanced Life Sciences Holdings, Inc. (ADLS) was higher on Tuesday after the Company announced positive results from Trial CL07-001, a thorough QT study of the Company’s novel once-a-day oral antibiotic, cethromycin. This study was conducted to evaluate the cardiac safety of cethromycin and to enhance the safety database for the Company’s upcoming New Drug Application (NDA) submission for cethromycin to treat community acquired pneumonia (CAP). The FDA requires thorough QT studies for all new chemical entities because prolongation in QT interval (corrected for changes in heart rate, or QTc, may signify an increased risk of developing cardiac arrhythmias.
At the therapeutic and supratherapeutic doses, cethromycin showed no signal of any electrocardiographic effects and, hence, the study supported its favorable cardiac safety profile. The Company has requested and established a meeting on April 7, 2008 with the FDA to discuss the anticipated NDA submission in CAP.
The CEO of Advanced Life Sciences Holdings, Dr. Michael Flavin, said in a conference call today, “Our NDA submission of cethromycin in CAP has been enhanced greatly by the results of this QT study. We are also engaged with the FDA and our national Advisory Board in order to submit the highest quality NDA.”
Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections. In in vitro tests, cethromycin appears to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin has a mechanism of action that may slow the onset of future bacterial resistance.
CAP is the sixth most common cause of death in the United States. Macrolides and penicillins are currently the first-line treatments for respiratory tract infections such as CAP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.
Dr. Flavin added, “The true market opportunity of cethromycin may also exist in its potential as an overall community-based antibiotic. We are advancing significant discussions with several potential partners that recognize the potential value beyond the CAP indication. We would envision a partnership that would be structured with upfront payments and milestones with down line royalties.”
“If approved, cethromycin would be entering a field with dwindling competition due to an increase in generic formulations of commonly prescribed drugs.”
The Company also reported today a fourth-quarter loss that was narrowed to $5.53 million, or 18 cents a share, from $5.9 million, or 21 cents a share, a year earlier. Analysts had expected a per-share loss of 16 cents. The Company used approximately $6.0 million in cash in the fourth quarter of 2007 and ended the year with cash totaling $18.3 million.
“Our overall R&D expenses are expected to be lower in 2008. Our cash burn this year will primarily be focused on the NDA submission for CAP,” commented Dr. Flavin.
Dr. Flavin concluded, “We made great progress in 2007 in the development of cethromycin. We expect this progress to continue in 2008. Cethromycin’s unique features form the basis of a strong NDA submission. If approved, it will help to differentiate cethromycin in the marketplace.”
The Company also has under development a compound, ALS-357, that has shown evidence of anti-tumor activity against malignant melanoma in preclinical studies. The Company has established an open IND for ALS-357 with the FDA and developed the protocol for a Phase I/II escalating dose study.
ALS-886 is a novel therapeutic of Advanced Life Sciences in preclinical development for the treatment of inflammation-related tissue damage, including tissue damage associated with acute respiratory distress syndrome (”ARDS”). Patients suffering from ARDS have a high fatality rate, and there are currently only limited treatment options available. The Company has established an IND application for ALS-886 with the FDA
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