application, or NDA, to the FDA in the fourth quarter of 2008.
-- Updated Phase 3 data on L-MTP-PE was presented at the Connective
Tissue Oncology Society, or CTOS, meeting in November 2007. Also,
data from our L-MTP-PE compassionate use program was presented at the
November 2007 meeting of the International Society of Pediatric
Oncology, or SIOP.
-- Announced Phase 3 Mifamurtide (L-MTP-PE) study demonstrating improved
survival was published in the Journal of Clinical Oncology in February
2008. Children's Oncology Group report shows the addition of L-MTP-PE
to chemotherapy reduced the risk of death by 30% in osteosarcoma
-- In June 2007, we completed a registered direct offering of our common
stock, and warrants to purchase common stock, and received
approximately $25.0 million in gross proceeds, and finished 2007 with
$28.4 million, providing cash for operations into the first half of
"We made significant progress over the past year in our efforts to
bring our lead product candidate, L-MTP-PE, to market in Europe," said
Timothy P. Walbert, president and chief executive officer, IDM Pharma. "We
are developing L-MTP-PE for the treatment of osteosarcoma, the most common
type of bone cancer affecting adolescents. We believe our updated survival
data from the L-MTP-PE Phase 3 trial, demonstrating statistically superior
overall survival in long-term patient follow-up, were critical to the
recent non-binding opinion of the Committee for Medicinal Products for
Human Use in Europe that L-MTP-PE suggested a possible clinical benefit in
terms of survival. We remain committed to resolving the remaining items of
the L-MTP-PE European Marketing Authorization Application and working at
the same time to advance this important potential treatment through its
U.S. regulatory path.
|SOURCE IDM Pharma, Inc.|
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