-Report Cites Potential for VAL-083 to Treat Refractory Glioblastoma Patients-
-AACR Data to be Reported this Sunday Demonstrates VAL-083 Retains Activity Independent of MGMT Repair-
Report is Available for Download at: www.lifesciadvisors.com/clients/delmar
NEW YORK, NY – March 30, 2012 – 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 Del Mar Pharmaceuticals (private), a clinical-stage biopharmaceutical company focused on developing cancer therapeutics for orphan indications. VAL-083 is a unique bi-functional alkylating agent, which is being developed by Del Mar Pharma for the treatment of glioblastoma multiforme (GBM) in patients refractory to Temodar® and Avastin® therapy. VAL-083 has been granted Orphan Drug Designation by the FDA and benefits from extensive NCI-sponsored development including detailed pre-clinical evaluation and over 40 NCI-sponsored human clinical studies representing an estimated $50MM in historical investment. Historically, VAL-083 has demonstrated an average response rate of 40% in glioblastoma patients.
“MGMT is the repair enzyme responsible for resistance to mono-functional alkylating agents, namely Temodar®, which is the current standard of care in combination with radiation for GBM patients,” said Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. “Furthermore, MGMT expression is correlated with decreased survival in GBM patients. Del Mar Pharma is due to report data at the upcoming AACR conference, which demonstrates that VAL-083 retains activity independent of MGMT repair due to its unique bi-functional alkylation mechanism.”
Currently, there is approximately a 25% 1-year survival rate for GBM patients that relapse after first-line therapy demonstrating a significant unmet medical need. Moreover, we estimate that 48% of GBM patients fail first and second-line therapies representing an initial market opportunity >$200MM for VAL-083. An oral version of VAL-083 could present an ideal product profile to advance to a first or second-line therapy resulting in an expanded market opportunity >$1B.
In a 40-page Initiation Report by LifeSci Advisors, the pre-clinical data to date is presented and the scientific rationale behind VAL-083 outlined. Previous Phase II studies by the NCI are broken down with a randomized study demonstrating a VAL-083 therapeutic benefit to radiation alone. Patients from this study treated with VAL-083 plus radiation or radiation alone, had a median survival of 16.8 months versus 8.8 months, respectively, or a treatment benefit of 8 months. In the report, a GBM disease background, market dynamics, competitive landscape, and the manufacturing and regulatory strategy of VAL-083 are elucidated.
Del Mar Pharma is currently conducting a Phase I/II study of VAL-083 in patients recurrent to GBM therapy. The Phase I portion of the study (n=20-30) has a dose-escalating design using a modernized dosing regimen and the primary endpoint is to reconfirm the maximum tolerated dose (MTD) in the context of modern care. Based upon the results from the Phase I portion and the modernized MTD, the Company plans to seek FDA guidance on a registration trial that could be conducted by expanding the Phase II portion of the trial to approximately 100 patients that are refractory to GBM therapy. We anticipate that the Phase I portion of this study will be complete by the end of 2012.
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.
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