Knobias Clip Report (12-30-2008) NFLD
Submitted By Knobias ClipReport
NFLD Shares Soar in Premarket After FDA Accepts BLA for PolyHeme(R)
By Fain Hughes, fhughes@knobias.com
Shares of Northfield Laboratories Inc. (NFLD) are up over 100% in premarket after the Company announced that the FDA has accepted for filing its Biologics License Application (BLA) for PolyHeme(R), the Company’s investigative human hemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available. In addition, FDA has designated the submission for Priority Review, with a review goal date of April 30, 2009.
PolyHeme(R) is a solution of chemically modified human hemoglobin that is designed for rapid, massive infusion. It requires no cross-matching and is therefore compatible with all blood types. It has an extended shelf life in excess of 12 months.
There is a significant clinical need for a safe and effective oxygen-carrying resuscitative fluid when blood is not available. Some of those situations include scenes of injury or disaster in civilian or military settings; transport to the hospital via ground or air ambulance; in the operating room in the case of unplanned surgical hemorrhage; in remote or rural settings, including hospitals, where blood may be in limited supply; in situations where the needs of multiple, simultaneously injured patients may overwhelm a hospital’s inventory of stored blood; in cases of inventory imbalance or inadequate supply; in cases of incompatibility; and in cases of religious objection to blood.
The early development of hemoglobin-based oxygen carriers (HBOCs) has been problematic. Early preparations of unmodified tetrameric hemoglobin were plagued by renal, hepatic, gastrointestinal, pancreatic, and cardiovascular toxicities and organ dysfunction. The small molecular-weight tetrameric species of hemoglobin have been implicated as causative agents associated with these unacceptable adverse effects. The basis of these adverse effects has been attributed to vasoconstriction due to the small molecular-weight tetrameric hemoglobin.
The preparation of PolyHeme(R), however, is designed to avoid these toxicities by removing essentially all vasoactive tetramer through high-yield polymerization and subsequent filtration to purify the solution.
Northfield has completed a multicenter Phase III trial designed to evaluate the safety and efficacy of PolyHeme(R) when used to treat patients in hemorrhagic shock following traumatic injuries. This was the first U.S. trial of a hemoglobin-based oxygen-carrying resuscitative fluid in which treatment began in the prehospital setting. Findings from this study were presented at the American College of Surgeons, appeared online in the Journal of the American College of Surgeons in November, and are scheduled for publication in the print edition in January 2009.
For the first fiscal quarter ended August 31, 2008, the Company reported a net loss of $5.9 million, or $.22 per share, compared with a net loss of $4.8 million, or $.18 per share, for the corresponding period last year.
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