The paper, entitled, 'Reduction in Surgical Site Infections by Localized Administration with D-PLEX100 in Patients with Multiple Risk Factors Undergoing Colorectal Surgery,' was published in the
The Phase 2 trial was a prospective, multicenter, randomized, controlled, single-blind, two arm study and was designed to assess the efficacy and the safety of D-PLEX100 in addition to standard of care (SoC) in preventing superficial and deep SSIs in patients undergoing elective colorectal surgery. This post-hoc analysis was intended to evaluate the effect of D-PLEX100 on SSI incidence in patients with multiple preoperative risk factors. Thirty-day SSI rates were examined in patients in the Intention-to-treat (ITT) population and in those with two or more patient related risk factors. Individual risk factor categories included diagnoses of diabetes, chronic obstructive pulmonary disease (COPD) or a history of smoking, obesity/overweight as defined as a body mass index (BMI) of 25 or more, hypertension, and peripheral vascular disease. The distribution of the assessed risk factors between the D-PLEX100 plus SoC and SoC cohorts was approximately even.
Two hundred and one patients were evaluated in the ITT population, 101 in the intervention arm and 100 in the control arm. The study showed a 53% statistically significant relative risk reduction of the SSI rate (superficial and deep) within 30 days post-index surgery in the D-PLEX100 cohort (N=10/101 [9.9%]) compared to SoC (N=21/100 [21%]; p = 0.033). In patients with two or more risk factors, the SSI rate in the D-PLEX100 plus SOC cohort was 15.8% (6/38) compared to 37.5% (15/40) in the SOC alone cohort, demonstrating a statistically significant relative risk reduction of 58% (p = 0.042).
The data from this post-hoc analysis are compelling, demonstrating that D-PLEX100 may be an effective addition to current SSI bundles in patients with increased risk for surgical complications, including SSI,' said
About D-PLEX100
D-PLEX100,
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Forward-looking Statements
This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as 'expects,' 'anticipates,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates' and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses that D-PLEX100 may be an effective addition to current SSI bundles in patients with increased risk for surgical complications, including SSI, that patients with one or more patient related risk factors could potentially benefit from D-PLEX100 and may help address the high unmet need in this vulnerable patient population. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the
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