While lack of efficacy data from experimental cancer drug tesmilifene rocked YM Biosciences
Earlier this month, YM announced that AeroLEF had met its primary endpoint in its randomized, placebo-controlled Phase 2b trial, which enrolled opioid-naive patients with post-operative pain following orthopedic surgery. The drug demonstrated a statistically significant difference in pain relief and pain intensity compared to placebo. AeroLEF is an inhaled formulation of the strong painkiller fentanyl, uniquely formulated to provide both immediate and prolonged relief from pain. Plans for future development of the drug include filing an IND (Investigational New Drug) with the FDA and initiating a phase 2 trial in the United States.
During the quarter, YM also advanced the global development of nimotuzumab through multiple licensees in several tumor types. Enrollment is expected to be completed during the first half of 2007 in a phase 3 trial of this experimental cancer drug as first-line therapy in pediatric pontine glioma, conducted by Oncoscience AG in Germany. YM is also in the planning stages of a phase 2 study for the same indication in North America, and the company anticipates filing an IND for a phase 2 trial evaluating the drug in colorectal cancer in the near term.
With a solid balance sheet -- more than $70 million in cash and no debt -- and encouraging results for AeroLEF, the future of YM Bio hinges on successfully advancing its two leading drug candidates through clinical trials. For patient biotech investors, YM shares are trading at attractive levels barely above the company's cash position, as the market awaits future clinical trial data and the potential commercialization of AeroLEF and nimotuzumab.
Looking for more Foolish biotech coverage? Check out the Fool's market-beating Rule Breakers newsletter service, which scours the market for innovators of all stripes and types. You can check out all of our recommendations, and get access to our message boards and exclusive content, with a 30-day free trial.
Fool contributor Mike Havrilla, R.Ph., B.S., Pharm.D., is a Rite Aid pharmacist who lives, writes, works, and enjoys running on the streets and trails in the small Pennsylvania town of Portage. He invites your comments and feedback. Mike does not have a position in any company mentioned in this article. The Fool has a disclosure policy.