YES! News out today on FDA approval for clinical trial!
Wednesday November 5 8:25 AM EST
Company Press Release
LXR Biotechnology Inc. Receives FDA Permission to Commence
Pivotal Clinical Trial for Heart Preservation Solution
RICHMOND, Calif., Nov. 5 /PRNewswire/ -- LXR Biotechnology Inc. (Amex:LXR) announced today that it has
received permission from the U.S. Food and Drug Administration (FDA) to commence a pivotal clinical trial on
its investigational device product, HK-Cardiosol(TM), a heart preservation solution.
LXR will proceed with clinical investigations in at least 6 medical centers (4 in the USA and 2 in Germany). A
minimum of 120 heart transplant patients will be enrolled in the study. In granting permission to the Company to
commence clinical trials, the Company is also required to make certain revisions to the protocol which is
expected to be completed within the 45 day period allotted by the FDA. LXR expects the trial to be completed as
early as the second quarter of 1999. If the trial is successful, a 510K submission will be made in the USA and
equivalent submission will be made in Europe.
''The commencement of this trial represents an important milestone as LXR continues in development of an
entirely new generation of drugs that regulate genetically programmed cell death,'' said L. David Tomei,
chairman and chief executive officer of LXR.
LXR is also developing a proprietary solution, CP-Cardiosol, for improved organ protection during heart/lung
bypass operations. The company plans to file an IND for CP-Cardiosol with the FDA this year. Approximately
650,000 heart/lung bypass operations are performed each year worldwide.
LXR Biotechnology Inc. is a biopharmaceutical company engaged in the research and development of innovative
therapeutics designed to treat diseases through the control of apoptosis or programmed cell death. Lead
compounds include HK-Cardiosol, a heart preservative solution for heart transplant; CP-Cardiosol, a
cardioplegia solution for bypass surgery; and Elirex for heart attack.
This press release contains forward looking statements regarding potential products and other matters. Words
such as ''believe'', ''expects'', ''likely'', ''may'', ''plans'' and ''could'' are intended to identify forward looking
statements, although not all forward looking statements contain these words. These forward looking statements
are subject to certain risks and uncertainties that could cause actual results to differ materially from those
forward looking statements, all of which are difficult to predict and many of which are beyond the control of the
company, including, but not limited to risks and uncertainties related to LXR's early stage of development,
results of research and development efforts, results of future clinical trials and future capital needs and the
uncertainty of additional funding, government regulation or approval of clinical trials, which are detailed in the
company's periodic reports and registration statements filed with the Securities and Exchange Commission. LXR
does not undertake to revise or update any forward looking statements to reflect events or circumstances that
may arise after the date hereof.
SOURCE LXR Biotechnology Inc. |
