Though still trading much closer to the bottom than the top of its 52-week range, IDM Pharma Inc.'s stock got an impressive boost Monday after the firm announced the publication of a long-term follow-up study demonstrating improved overall survival in bone cancer patients receiving the company's mifamurtide, which formerly went by the name Junovan.

The analysis was published in the Feb. 1, 2008, issue of the Journal of Clinical Oncology by researchers from the Children's Oncology Group.

The results had first been presented at the annual meeting of the Connective Tissue Oncology Society last November. But that publication, IDM's CEO Tim Walbert told BioWorld Today, was merely a "small encapsulation" of the data as opposed to a full publication in a peer-reviewed journal.

The analysis evaluated the use of mifamurtide with either a three-drug or four-drug chemotherapy regimen, comparing overall survival and event-free survival between the groups in 662 patients with newly diagnosed nonmetastatic osteosarcoma.

At 78 percent, overall survival after six years of follow-up was significantly higher in patients receiving additional mifamurtide compared to those who received chemotherapy alone. The results translated to approximately 30 percent decrease in the risk of death.

The researchers also looked at differences in event-free survival between the groups. Here, the data missed significance - though at a p value of 0.08, or not by much.

Walbert said the finding was not part of the planned analysis and would not affect the company's dealings with the FDA, and also noted that given that the trial had not been powered to detect differences in event-free survival, the company regards the trend toward event-free survival as essentially good news.

IDM Pharma (NASDAQ;IDMI) ended the day up 35 cents, or 44.3 percent, to close at $1.14. That investor enthusiasm is a bit of much-needed good news for the company, which has been in something of a rough patch.

The company hired consultants to evaluate its strategic options in December. That evaluation took on a new urgency after the Sanofi-Aventis group bailed on its collaboration for IDM's Uvidem, which is in Phase II trials for melanoma. (See BioWorld Today, Jan. 2, 2008.)

The loss of a partnership came not too long after the company received a non-approvable letter asking for more clinical data from the FDA last August. (See BioWorld Today, Aug. 28, 2007.)

Ironically, at that point the six-year survival data for mifamurtide could have been available to the FDA, but it was not used in the agency's decision, which was based, Walbert said, on data from 2003.

Walbert, who joined the company as CEO shortly after the FDA's non-approvable letter, noted that the FDA did not ask for the extended survival analysis prior to reviewing the data in 2007.

But he also said that "our belief is that there is an opportunity to improve the quality of the NDA," and that is what the company intends to do with an amended NDA in the second half of the year. The company is working with the Children's Oncology Group to "capture all patients, especially those that were lost to follow-up," which amounts to roughly 20 percent of the trial participants at this time.

The first priority, however, is to work with the European Committee for Medicinal Products for Human Use, where IDM filed an application in November 2006. The European regulatory agency, where the filing is based on the 2006 data, has been more positive toward mifamurtide than the FDA. At the end of January, the agency announced its opinion that the drug provides a "possible" survival benefit, but also asked for clarification about the data as well as additional information on chemistry, manufacturing and controls.

Walbert said the company expects to provide the required data and receive an opinion from the committee by the third quarter, and a final decision from the European commission by the fourth quarter.

As for whether the company will take advantage of the stock's climb for any financing activity, Walbert said that IDM still was evaluating its options, but declined to comment on any specific financing activities.