VANCOUVER, and SAN DIEGO, May 1 - - MIGENIX Inc. (TSX: MGI; OTC:
MGIFF), a clinical-stage developer of drugs for infectious diseases, reports
that the Company's development and commercialization partner for the North
American and European markets for Omigard(TM) (CPI-226), Cadence
Pharmaceuticals, Inc. ("Cadence") announced that it intends to discuss with
the U.S. Food and Drug Administration (FDA) a proposal to increase the number
of patients to be enrolled in the ongoing, Phase III clinical trial of
Omigard.
"In discussions with Cadence regarding their preparations for regulatory
submissions, we agreed with their approach to enhance the statistical power of
the study and allow a better opportunity to achieve a positive result in this
pivotal Phase III study," stated Jim DeMesa, M.D., President and CEO of
MIGENIX. "While the timelines for completing enrollment in the study are
anticipated to change, it will be well worth it if the planned increase leads
to a positive result."
The following is the text of Cadence's April 30, 2007 announcement:
Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), announced today that it
intends to discuss with the U.S. Food and Drug Administration (FDA) a proposal
to increase the number of patients to be enrolled in the ongoing Phase III
clinical trial of its experimental product candidate, Omigard(TM) (omiganan
pentahydrochloride 1% aqueous gel) for the prevention of local catheter site
infections (LCSIs). This ongoing trial is known as the Central Line Infection
Reduction Study, or CLIRS trial.
The plan to increase the number of patients in the CLIRS trial is
intended to maintain the statistical power of the trial and was prompted by
the company's planned re-analysis of data from the initial Phase III clinical
trial of this product candidate. This extensive re-analysis is being performed
as part of the standard procedure for analyzing data to prepare a final report
of the study for a potential New Drug Application or other applications for
marketing authorization. The re-analysis, which uses a slightly different,
stricter definition of LCSI, indicates a statistically significant reduction
of LCSIs of approximately 42% in the Omigard treatment arm as compared to the
povidone-iodine treatment arm (the previous analysis indicated an
approximately 49% reduction), as well as a reduction in the overall LCSI
infection rate. The catheter colonization and catheter-related bloodstream
infection results from the initial Phase III study were not impacted by the
re-analysis.
Because the target sample size for the CLIRS trial is based, in part,
upon the LCSI rate and treatment effect, the company now believes that adding
patients is prudent in order to maintain the statistical power of the study.
Additionally, improvements to hospital infection prevention practices since
the CLIRS trial began may reduce catheter-related infection rates, further
supporting an increase in the number of patients.
The CLIRS trial is being conducted under a Special Protocol Assessment
(SPA) with the FDA, so Cadence must obtain the FDA's concurrence with the
proposal to increase enrollment in this trial. The company intends to initiate
discussions with the FDA immediately.
"We are taking these measures because we believe they will enhance the
statistical power of this study and allow us a better opportunity to achieve a
positive result in the CLIRS trial. Clearly, our efforts will be focused on
accelerating enrollment in order to off-set as much as possible the longer
duration of the trial," said Ted Schroeder, Cadence Pharmaceuticals' President
and Chief Executive Officer. "After we have completed our discussions with the
FDA, we expect to announce details regarding the number of patients to be
added to the trial, the anticipated financial impact, and other potential
implications on the Omigard development program. However, we currently
anticipate that adding patients to the CLIRS trial will move the completion of
enrollment in this study from the second half of 2007 to mid-2008."
Cadence Conference Call and Webcast Details
Cadence's management will host a conference call on Tuesday, May 1 at
8:30 am Eastern Time (5:30 am Pacific Time) to discuss today's announcement.
Interested investors and others may participate in the conference call by
dialing (800) 811-0667 (domestic), or (913) 981-4901 (international). A replay
of the webcast and teleconference will be available approximately two hours
after the call. To access the webcast, please log on to the company's website
at www.cadencepharm.com at least 15 minutes prior to the call to ensure
adequate time for any software downloads that may be required. The webcast
will remain available on the company's website for fifteen days.
About the Omigard Clinical Development Program
Cadence's ongoing Phase III trial of Omigard for the prevention of LCSIs
(known as the Central Line Infection Reduction Study, or CLIRS trial) is a
multi-center, randomized, evaluation committee-blinded study in patients whose
medical condition requires a central venous catheter (CVC). The primary
efficacy endpoint of the clinical trial is to evaluate whether Omigard is
superior to 10% povidone-iodine in the prevention of LCSI in patients
requiring central venous catheterization. The CLIRS trial, which was designed
to recruit 1,250 patients randomized to receive either Omigard or 10%
povidone-iodine, began enrollment in August 2005 and is currently being
conducted at centers in the United States and Europe. The CLIRS trial is
designed to have 80% power to detect significance at the 0.05 level. The
Omigard development program holds fast track status from the FDA.
In February 2003, Cadence's licensor for Omigard, MIGENIX, Inc. (then
known as Micrologix Biotech Inc.) and Astellas Pharma, Inc. (then known as
Fujisawa Healthcare, Inc.), MIGENIX' former collaborator, completed a
multi-center, randomized, evaluation committee-blinded Phase III trial that
compared Omigard to 10% povidone-iodine in patients receiving CVCs,
peripherally inserted central catheters, and/or arterial lines. The study was
conducted in 1,407 patients in 27 centers in the United States. The primary
efficacy endpoint was to evaluate the superiority of Omigard compared to 10%
povidone-iodine for the prevention of catheter related bloodstream infections
(CRBSIs). Secondary efficacy endpoints included evaluating the superiority of
Omigard for the prevention of LCSI and catheter colonization. The initial
Phase III clinical trial demonstrated statistically significant results for
the two secondary endpoints of this trial but did not show statistical
significance for the primary endpoint, the prevention of CRBSIs.
(End of Cadence's announcement)
About MIGENIX
MIGENIX is committed to advancing therapy, improving health, and
enriching life by developing and commercializing drugs primarily in the area
of infectious diseases. The Company's clinical programs include drug
candidates for the treatment of chronic hepatitis C infections (Phase II and
preclinical), the prevention of catheter-related infections (Phase III) and
the treatment of dermatological diseases (Phase II). MIGENIX is headquartered
in Vancouver, British Columbia, Canada with US operations in San Diego,
California. Additional information can be found at www.migenix.com.
"Jim DeMesa"
------------
James M. DeMesa, M.D.
President & CEO
FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements within the meaning
of the United States Private Securities Litigation Reform Act of 1995, and
forward-looking information within the meaning of applicable securities laws
in Canada, (collectively referred to as "forward-looking statements").
Statements, other than statements of historical fact, are forward-looking
statements and include, without limitation, statements regarding our strategy,
future operations, timing and completion of clinical trials, prospects, plans
and objectives of management. The words "anticipates", "believes", "budgets",
"could", "estimates", "expects", "forecasts", "intends", "may", "might",
"plans", "projects", "schedule", "should", "will", "would" and similar
expressions are often intended to identify forward-looking statements, which
include underlying assumptions, although not all forward-looking statements
contain these identifying words. By their nature, forward-looking statements
involve numerous assumptions, known and unknown risks and uncertainties, both
general and specific, that contribute to the possibility that the predictions,
forecasts, projections and other things contemplated by the forward-looking
statements will not occur.
Although our management believes that the expectations represented by
such forward-looking statements are reasonable, there is significant risk that
the forward-looking statements may not be achieved, and the underlying
assumptions thereto will not prove to be accurate. Forward-looking statements
in this news release include, but are not limited to, statements concerning:
Cadence's belief that adding patients is prudent in order to maintain the
statistical power of the study; Cadence's intention to initiate discussions
with the FDA immediately; and Cadence currently anticipating that adding
patients to the CLIRS trial will move the completion of enrollment in the
study from the second half of 2007 to mid-2008.
With respect to the forward-looking statements contained in this news
release, there are numerous assumptions regarding, among other things:
Cadence's ability to enroll sufficient patients to complete the pending Phase
III clinical trial of Omigard; and the anticipated timing and Cadence's
ability to obtain the FDA's concurrence to increase patient enrollment and
ultimately complete the trial.
Actual results or events could differ materially from the plans,
intentions and expectations expressed or implied in any forward-looking
statements, including the underlying assumptions thereto, as a result of
numerous risks, uncertainties and other factors including: dependence on
corporate collaborations; the potential that the FDA may not agree with
Cadence's proposal to increase patient enrollment, or may apply a statistical
penalty to the clinical trial; uncertainties related to early stage of
technology and product development; uncertainties as to the requirement that a
drug be found to be safe and effective after extensive clinical trials and the
possibility that the results of such trials, if completed, will not establish
the safety or efficacy of our products; uncertainties as to future expense
levels and the possibility of unanticipated costs or expenses or cost
overruns; the possibility that opportunities will arise that require more cash
than presently anticipated and other uncertainties related to predictions of
future cash requirements; and other risks and uncertainties which may not be
described herein. Certain of these factors and other factors are described in
detail in the Company's Final Prospectus dated November 29, 2006, Annual
Information Form and Annual Report on Form 20-F for the year ended April 30,
2006 and other filings with the Canadian securities regulatory authorities and
the U.S. Securities & Exchange Commission.
Forward-looking statements are based on our current expectations and
MIGENIX assumes no obligations to update such information to reflect later
events or developments.
The Toronto Stock Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of this release.
