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news.Shares in Maxim Pharmaceuticals plunged by over 20% before recovering, after the company announced disappointing trial results for Ceplene and a corporate realignment that will include 12 job cuts.
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Preliminary data from the phase II trial of Ceplene, conducted in cooperation with Schering-Plough, in combination with PEG-Intron and Rebetol for the treatment of hepatitis C patients who failed to respond to previous therapy, did not improve virological response compared to treatment with the PEG-Intron and Rebetol alone.
Meanwhile, preliminary analyses of two investigator-driven studies with Ceplene plus Interleukin-2 (IL-2) versus IL-2 alone in patients with metastatic renal cell carcinoma, have also been completed.
One study performed in Denmark showed a trend towards improvement in patients treated with Ceplene plus IL-2 versus IL-2 alone in overall survival, but not tumor response. There was no difference in overall survival or tumor response in patients treated with Ceplene plus IL-2 compared to treatment with IL-2 alone, in the second study performed in the UK.
In view of recent developments in Ceplene’s regulatory path and clinical results, Maxim has implemented a plan to realign its resources and corporate objectives. This includes cutting 12 jobs and provides sufficient capital to fund currently planned activities for the next year and a half. Most of the cuts are related to Ceplene development programs, which are winding down, but do not impact Maxim’s core drug development or drug discovery teams, which remain intact.
Maxim will now focus on advancing its apoptosis modulator discovery and development program, advancing current lead oncology compounds towards the clinic and seeking a worldwide development and marketing partnership for Ceplene and an oral histamine formulation.
The company also plans to engage an investment banking firm to assist in identifying and evaluating strategic opportunities that best leverage and build on current assets, including the company’s research and core drug development teams and its apoptosis modulator discovery platform and pipeline.
“The last several months have been a challenge for Maxim, but we continue to believe that Maxim has assets, such as a strong drug discovery program and core drug development team, that can provide shareholders with meaningful value,” stated Larry Stambaugh, Maxim’s president and CEO.