Maxim realigns its objectives

Maxim Pharmaceuticals has implemented a plan realigning its resources and corporate objectives.

The realignment is based upon the need for an additional Phase III trial of Ceplene therapy for the treatment of Acute Myeloid Luekemia before Maxim can submit a New Drug Application to the FDA. It also follows disappointing resukts for Ceplene in the treatment of Hep C and various cancers.

One result is a reduction of Maxim's workforce by 12 to 39 employees. The changes should provide sufficient capital to fund currently planned activities for approximately 18 months from January 2005. Most of the reductions are related to the company's Ceplene development programs, which are winding down, but do not impact Maxim's core drug development or drug discovery teams, which remain intact.

Maxim released preliminary data from its Phase II trial, conducted in cooperation with Schering-Plough, of the investigational drug Ceplene (histamine dihydrochloride) in combination with PEG-Intron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) for the treatment of hepatitis C patients who failed to respond to previous therapy. The data showed the regimen did not improve virological response compared with treatment with the PEG-Intron and Rebetol alone. However, the combination therapy was generally well tolerated, and safety was consistent with previous clinical experience.

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 (p=0.08), but not tumour response. There was no difference in overall survival or tumour 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 the setbacks in Ceplene's regulatory path and clinical results, Maxim has realigned its objectives to focus on the following initiatives:

• advance Maxim's apoptosis modulator discovery and development program through the screening of new compound libraries

• advance current lead oncology compounds towards the clinic either internally or in collaboration with partners through licensing agreements.

• engage an investment banking firm to assist in identifying and evaluating strategic opportunities that best leverage and build on Maxim's assets, including its research and core drug development teams, as well as its apoptosis modulator discovery platform and pipeline that uses high throughput technology to screen for molecules that specifically modulate the apoptosis pathway.

• seek a worldwide development and marketing partnership for Ceplene and Maxim's oral histamine formulation.

'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. We remain committed to efforts to deliver that value by developing and applying these assets in a manner that may include a strategic transaction that makes sound business sense,' stated Larry Stambaugh, Maxim's president and chief executive officer.