Article Excerpt:
TWST: We would like to begin with a brief historical sketch of MIGENIX and a picture of the things you are doing at the present time.Dr. DeMesa: Our company was founded in 1993 based on an antimicrobial technology from the University of British Columbia. Today, we are a drug development company with a broad portfolio of product candidates focused on the prevention and treatment of infectious and degenerative diseases. Our pipeline consists of compounds and technologies in various phases of development from late stage clinical programs (Phase II and Phase III) to early preclinical programs. Currently, we have a Phase III product candidate, omiganan 1% gel (CPI-226), which we feel is within two years of becoming a potential revenue stream for us. This product is indicated for the prevention of percutaneous device-related infections, with an initial focus on catheter-related infections (one of the most frequent nosocomial infections in hospitals). Next, we have a product candidate in Phase II for the treatment of chronic hepatitis C virus infections, a disease with high unmet medical need. It is called celgosivir, or MX-3253. And, we have several products in our pipeline, being developed for indications such as serious bacterial infections, dermatological conditions, and neurodegenerative diseases.
TWST: Would you give us a brief explanation of the one that is in Phase III, the
one that is related to catheter infections, and the hepatitis C?
Dr. DeMesa: Our latest-stage product candidate is currently in its second Phase
III clinical study for preventing catheter-related infections in the hospital.
This is a potent, topical, broad-spectrum anti-infective, which is placed at the
insertion site of indwelling catheters, such as central venous catheters (CVCs).
The active ingredient in this product is an antimicrobial cationic peptide,
which is in a gel formulation. It is used around the insertion site of catheters
at the time of insertion and at each dressing change, which typically occurs
around three to four times during the life of the catheter (approximately every
three days). This product has already completed a large Phase III trial (1,400
patients), with statistically significant results in the endpoint required for
approval. It has been granted a Special Protocol Assessment, or SPA, from the US
FDA, providing us an agreement with the agency for the requirements for approval
of the drug. With the SPA, the product has relatively low regulatory risk. It
also has relatively low clinical risk because of the highly statistically
significant results in the first Phase III trial. In addition, we have partnered
this product in North America and Europe with Cadence Pharmaceuticals, a
specialty pharma company based in San Diego. Cadence is paying for the
development of the product and will be commercializing it once approved. So, our
financial risk on this product is essentially zero. So, bottom line, we have
relatively low risk product opportunity here with CPI-226, which has a
relatively near-term opportunity for revenues for us.
The second product in our pipeline is in Phase II for the treatment of chronic
hepatitis C virus infections. This is currently undergoing two clinical trials
in hepatitis C. One study is in a non-responder population (patients who have
failed on previous therapy). This study has completed enrollment and so we
expect final (12-week) results in the October, November time frame this year. We
also have a treatment-naive study (in patients who have never been on anti-HCV
therapy) that is just about to start enrollment, and we expect four-week interim
results before the end of the calendar year and final results in the first half
of 2007. So there will be several near-term clinical results on this program
within the next year, and then another clinical result in our Phase III trial
for our catheter product, CPI-226, sometime in the second half of next year
(2007).
Tickers included in this excerpt: MGI:TSX
TWST Newsletter
For more information call (212) 952 7433. The Wall Street Transcript does not endorse any of the comments made by interviewees, and does not make stock recommendations.