NEW YORK, NY -- (Marketwire) -- 03/01/13 -- LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Adherex Technologies Inc. (TSX: AHX) (OTCQB: ADHXF), a clinical-stage biotechnology company focused on the development of eniluracil (EU) in combination with 5-fluorouracil (5-FU) and leucovorin (LV) to treat metastatic breast cancer. The drug is being compared to Xeloda® in a Phase II trial that completed enrollment at the end of 2012, with data expected in mid-2013. Preliminary results demonstrate that patients who had rapid disease progression on Xeloda and then crossed over to take EU/5-FU/LV experienced 89% clinical benefit and 33% tumor response. A small clinical trial with these patients may be an attractive path for rapid entry into the market.
"Adherex's eniluracil development program has the potential to provide reliable oral administration of the important chemotherapeutic 5-fluorouracil for patients with metastatic breast cancer, with an improved side-effect profile," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "Further, eniluracil could potentially allow patients who rapidly fail Xeloda to continue with another oral 5-FU therapy rather than switching to the less well-tolerated microtubule-interfering agents."
Adherex's lead compound, eniluracil (EU), enhances the chemotherapeutic drug 5-fluorouracil (5-FU). Adherex is developing EU in combination with 5-FU and leucovorin (LV) to treat metastatic breast cancer (MBC). In April 2011, Adherex began a Phase II trial (AHX-03-202) comparing the efficacy and safety of EU/5-FU/LV versus Xeloda (capecitabine) in MBC patients. The trial randomized patients (4:3) to receive EU/5-FU/LV (Arm 1) or Xeloda (Arm 2), where patients on Xeloda (Arm 2) with disease progression have the option to switch over and take EU/5-FU/LV (Arm X). The primary endpoint is progression free survival (PFS). The goal of the trial is to compare the efficacy and safety of EU/5-FU/LV versus Xeloda. Enrollment of the Phase II trial is complete and data is expected in mid-2013.
Adherex is also developing Sodium Thiosulfate (STS), a chemoprotectant against hearing loss associated with platinum-based chemotherapy. Adherex partners, the Children's Oncology Group (COG) and the International Childhood Liver Tumor Strategy Group (SIOPEL) are each conducting a Phase III trial comparing cisplatin with the combination of cisplatin plus STS in children with cancer. The primary endpoint is hearing loss. The fully-enrolled, COG-sponsored trial was designed to enroll 135 pediatric patients worldwide in five different disease indications. Enrollment for the COG-sponsored trial is complete and data are expected in 2013. The SIOPEL sponsored trial will enroll 100 pediatric patients with liver cancer worldwide, of which 62 patients were enrolled as of November 10, 2012.
In a 43 page Initiation Report by LifeSci Advisors, we explain the potential advantages of EU/5-FU/LV when compared to Xeloda, the market opportunity for eniluracil, and the treatment paradigm and competitive landscape for metastatic breast cancer treatment. The report also includes an explanation of the mechanism of action and a detailed background of the clinical development program for eniluracil.
Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company's website, www.lifesciadvisors.com.
The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company. LifeSci Advisors has been compensated by the company that is the subject of the report described and future research reports, investor relations services, and general consulting services. Please read each report's full disclosures and analyst background on the LSA website, www.lifesciadvisors.com, before investing. LifeSci Advisors is not a registered investment adviser or broker-dealer.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent LSA's judgment as of the date of this release. LifeSci Advisors disclaims, however, any intent or obligation to update these forward-looking statements.
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