OCEANPORT, N.J., Jan. 5 /PRNewswire-FirstCall/ -- Life Medical Sciences, Inc. (BULLETIN BOARD: CHAI.OB) , today announced that a planned interim analysis of patient data from its REPEL-CV pivotal clinical trial was completed by a Data and Safety Monitoring Board ("DSMB") comprised of medical and biostatistical specialists who are not participating in this clinical trial. Based on data from over forty patients, the DSMB recommended that the trial proceed as planned and that no modifications to the trial protocol were indicated. To preserve the integrity of the clinical trial, the Company remains blinded to the data. According to Eli Pines PhD, the Company's Vice President of Research, "The DSMB recommendation suggests there is a reasonable likelihood that the clinical endpoint can be met to establish the efficacy of REPEL-CV and there are no unexpected safety issues associated with the product use."
Patient enrollment in the REPEL-CV trial began in early 2004 involving neonatal patients who require a staged series of open heart surgical procedures. Post-operative adhesion formation is a prevalent and serious complication experienced in the approximately 1 million open heart surgical procedures performed worldwide on an annual basis. REPEL-CV could become the first adhesion barrier approved by the FDA for use in cardiac surgery which could represent a $250 million annual worldwide market opportunity. Life Medical Sciences, Inc. is a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products. The Company is developing a broad range of bioresorbable polymer products to prevent/reduce post-operative adhesion formation.
Statements in this Press Release that are not statements of historical fact, including statements regarding indications of the potential outcome of the REPEL-CV clinical trial, the timing or ability to achieve regulatory approval in respect of REPEL-CV or the potential market size for REPEL-CV, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include but are not limited to (i) potential adverse developments regarding the progress, timing and results of the clinical trial and the Company's efforts to obtain required FDA approval, including that the DSMB recommendation described in this Press Release is not indicative of the results of the trial and that failure can occur at any stage of testing and (ii) potential inability to secure funding as and when needed to support the trial and the Company's other activities. Reference is made to the Company's Annual Report on Form 10-KSB for the year ended December 31, 2003 for a description of these, as well as other, risks and uncertainties.
Life Medical Sciences, Inc.
CONTACT: Robert P. Hickey of Life Medical Sciences, Inc.,+1-732-728-1769, firstname.lastname@example.org