IDM Pharma Announces Data Presentation From Mifamurtide (L-MTP-PE) Compassionate Use Program
Friday November 2, 6:00 am ET
IRVINE, Calif., Nov. 2 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI - News) today announced the presentation of data from a compassionate use program evaluating mifamurtide (L-MTP-PE) in patients with lung metastases as a result of the progression of osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults. The data show that L-MTP-PE in combination with other therapies is safe, well-tolerated and exhibited signs of disease control.
"These results are encouraging as there is a significant unmet treatment need for patients with osteosarcoma," said Dr. Peter Anderson, professor of pediatrics, The University of Texas M.D. Anderson Cancer Center in Houston. "The safety and tolerability as well as signal of disease control associated with L-MTP-PE treatment in combination with other agents is promising as we continue to investigate therapies to control lung metastases as a result of the progression of osteosarcoma."
The data were presented during a poster presentation at the 39th Congress of International Society of Pediatric Oncology (SIOP) today in Mumbai, India.
Study design and findings
Thirteen high-risk osteosarcoma patients have been treated in the compassionate use program to date. Patients in the program had documented diagnosis of high grade osteosarcoma with relapsed or recurrent disease, locally or metastatic, with resectable or not completely resectable disease, or who are unable to complete recommended chemotherapy due to toxicity.
L-MTP-PE (2 mg/m2 IV over 1 hour) was administered twice a week for 12 weeks followed by once a week for 24 weeks in combination with aerosol recombinant granulocyte monocyte colony stimulating factor (GM-CSF), an immune stimulating agent. In addition, some patients in the program were also treated with gemcitabine (n=2) or ifosfamide (n=2). Daily lung function was monitored in some patients during aerosol GM-CSF using remote spirometry.
L-MTP-PE in combination with aerosol GM-CSF results:
-- One of three patients who completed treatment remains without active lung metastases.
-- Two patients that stopped treatment prior to receiving 40 doses (one for pleural effusion) have showed no signs of lung metastases (past 12 months); one of these patients had disease progression in Inferior vena cava (IVC) blood clot and pelvis.
-- Nine of 13 patients have developed and/or had progression of lung metastases.
-- Four of 13 patients survive free of lung metastases.
Treatment with L-MTP-PE combined with aerosol GM-CSF was generally well tolerated. The most common adverse events were fever and malaise, which occurred in all patients within five hours of the first dose and was successfully treated with ibuprofen 400 mg. Two patients developed pleural effusions (one malignant effusion), which was resolved in one patient by stopping treatment and in the other patient with intra-pleural cisplatin treatment.
"The experience in our pivotal Phase 3 trial, in addition to the compassionate use experience, shows that L-MTP-PE may be a viable treatment option for osteosarcoma patients with non-metastatic disease as well as patients with lung metastases," said Timothy P. Walbert, president and chief executive officer, IDM Pharma. "We continue to provide L-MTP-PE via compassionate use to help as many patients as possible with this devastating disease." |
