Migenix
to Add 600mg Daily Celgosivir Dose to Phase II Viral Kinetics Study VANCOUVER
and SAN DIEGO, Jan. 31 -- PRNewswire-FirstCall -- Migenix Inc.(TSX: MGI, OTC:
MGIFF), a clinical-stage developer of drugs for infectious diseases, will add
a 600 mg celgosivir combination therapy arm to its currently enrolling Phase II
viral kinetics study in hepatitis C virus ("HCV") treatment-naive patients.
The protocol amendment to this study has received Health Canada and Institutional
Review Board (IRB) approvals. The purpose of this new treatment arm is to assess
600 mg celgosivir (an oral alpha glucosidase I inhibitor) for tolerability, pharmacokinetics
and viral kinetics when combined with the standard of care drugs, pegylated interferon
plus ribavirin, as compared to the standard of care drugs alone and to 400mg celgosivir
plus the standard of care for up to 12 weeks of therapy. AnnKatrin
Petersen, MD, VP Clinical Development for Migenix, commented, "The favorable
tolerability experienced to date with 400 mg per day of celgosivir in triple combination
with pegylated interferon plus ribavirin, along with the clinically significant
benefit demonstrated in our previous non-responder study, gives us confidence
that increasing the dose to 600mg per day in combination therapy is an important
development step for the optimization and advancement of celgosivir." The
currently enrolling Phase II viral kinetics study is a 12-week randomized, active-controlled
study initially planned to enroll up to 20 patients in two treatment arms: (i)
celgosivir (400mg once daily) plus peginterferon alfa-2b [PegIntron] plus ribavirin;
and (ii) peginterferon alfa-2b plus ribavirin. Tolerability, pharmacokinetics
and viral kinetics are being evaluated in the trial. The approved protocol amendment
allows for the addition of a 600mg once daily dosing arm and the flexibility to
increase the total number of patients in the study up to 50.
With 15 patients
enrolled to date, it is planned that approximately six additional patients will
be enrolled, all in the new 600 mg arm. Results from the study are expected to
be reported in the third calendar quarter 2008. Jim
DeMesa, MD, President and CEO of Migenix, added, "With results from this
study expected in the third quarter 2008, we now have another near-term clinical
milestone. Additional key clinical milestones include Omigard Phase III results
for preventing catheter-related infections (CLIRS study) expected by our partner,
Cadence Pharmaceuticals, in the second half of 2008 (enrollment to be completed
in the second quarter) and Cutanea Life Sciences, our partner in the CLS001 rosecea
product, planning to advance CLS001 to Phase III." About
Celgosivir (MX-3253) Celgosivir,
an oral inhibitor of alpha-glucosidase I, is currently the only anti-HCV drug
in clinical development which acts on host-directed glycosylation. In preclinical
studies, celgosivir has shown in vitro synergy with various interferons on the
market or in development including Pegasys, PEGIntron, Infergen, Alferon and IFN-omega
(with or without ribavirin) and other drugs in development for the treatment of
HCV (e.g. polymerase inhibitors) and therefore could have the potential to be
included as part of many combination therapeutic approaches to improve efficacy
in future anti-HCV therapies. Results
announced in April 2007 from a Phase II study demonstrated a clinically significant
benefit when celgosivir was added to the standard of care in non-responder patients.
Interim results from the first 10 patients in the current viral kinetics study
who had completed 4-weeks of therapy were reported in December 2007. Detailed
analysis of data from these two studies, and an extension protocol designed to
provide expanded access to the non-responder patients, provided the rationale
for increasing the dose of celgosivir from 400mg per day to 600mg per day in combination
therapy as the next step for the optimization and advancement of celgosivir. 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 http://www.migenix.com. |