Navigation Links
Immune-based drug approved in Europe for pediatric cancer patients
Date:3/10/2009

HOUSTON ? The European Commission, which oversees legislation and regulation for the European Union, has approved a therapy for pediatric patients with non-metastatic, resectable osteosarcoma, a type of bone cancer. The approval is based on clinical studies led by researchers at The University of Texas M. D. Anderson Cancer Center and a national co-operative group.

MEPACT (mifamurtide, L-MTP-PE) is an immune-based therapy, that when combined with chemotherapy, resulted in approximately a 30 percent decrease in the risk of death with 78 percent of patients surviving more than six years following treatment. This therapy is the first in more than 20 years to improve the long-term survival of osteosarcoma patients.

Eugenie Kleinerman, M.D., head of the Children's Cancer Hospital at M. D. Anderson Cancer Center, was the first investigator to translate the drug from preclinical testing to a Phase I clinical trial in humans. She also led the Phase II clinical trial for pediatric patients with relapsed osteosarcoma, which was followed by a Children's Oncology Group Phase III trial for newly diagnosed patients.

Kleinerman originally proposed the use of this immune therapy for osteosarcoma after Isaiah J. Fidler, D.V.M., Ph.D., professor in M. D. Anderson's Department of Cancer Biology and director of the Center for Metastasis Research, demonstrated that MEPACT induced the regression of melanoma lung metastases in mice.

"When he showed that MEPACT caused the macrophages in the lung to kill tumor cells, I decided that the drug may have therapeutic potential in patients with osteosarcoma, which most often metastasizes to the lungs," says Kleinerman. "From my own preclinical research, we were able to show how MEPACT stimulated human immune cells to react against osteosarcoma cells."

MEPACT works by stimulating certain white blood cells, called macrophages, to kill tumor cells. The drug is shaped in a sphere, also known as a vesical, made up of lipids. Inside the vesical is muramyl tripeptide (MTP). The lipids trigger the macrophages to consume MEPACT. Once consumed, the MTP stimulates macrophages, particularly in the liver, spleen and lungs, to find tumor cells and kill them.

Patients undergo pre-operative chemotherapy followed by surgery to resect the bone tumor and then receive post-operative chemotherapy. While receiving post-operative chemotherapy, patients also are given the immune therapy intravenously twice a week for three months and then once a week for six months. The chemotherapy acts like a bomb sent in to destroy the tumor, while MEPACT acts as a special forces unit sent in to clean out any remaining pockets of microscopic disease.

"Relapsed osteosarcoma is often resistant to chemotherapy," says Kleinerman. "By giving MEPACT to newly diagnosed patients, we hope to prevent relapse by taking care of any remaining tumor cells after chemotherapy."

Currently, only relapsed pediatric patients with osteosarcoma are able to receive treatment with MEPACT through compassionate use in the United States. MEPACT was granted orphan drug status in the United States in 2001 but has not been approved by the Food and Drug Administration for use in newly diagnosed patients. Orphan drug status is given to therapeutic agents that target rare diseases as an incentive for pharmaceutical companies to manufacture these agents.

"We have been working with this therapy for more than two decades, so getting approval in Europe is a huge milestone for those of us fighting pediatric cancer," says Kleinerman. "This drug has made significant strides for long-term survival of children with osteosarcoma."


'/>"/>

Contact: Sara Farris
sfarris@mdanderson.org
713-792-9133
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert

Related medicine news :

1. $52.5 Million Settlement Against Sepracor Inc. Approved
2. FDA Cracks Down on Unapproved Cough Medicines
3. Video: New FDA-Approved Sun Protectant Saves Skin All Year Round
4. Optometry-Backed Vision Care for Kids Act Approved by U.S. House
5. Voltaren(R) Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis
6. A fresh look at existing therapies: Researchers explore ways to teach approved drugs new tricks
7. Barrs Generic Version of Estrostep(R) Fe Tablets Approved
8. PEGINTRON(TM) and REBETOL(R) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy
9. Pennsylvania American Waters Rate Case Approved
10. RNs Statement on Death of Nataline Sarkisyan: CIGNA Should Have Listened to her Doctors and Approved the Transplant a Week Ago
11. Hiemstra Approved to Manufacture Medical Devices in New CER
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... ... ... According to a new study by NCPA Senior Fellow John R. Graham, "the ... has directed the CBO to follow. The CBO itself previously recognized Obamacare would kill ... a reduction in employer-based coverage due to the GOP reform, which is not plausible. ...
(Date:3/24/2017)... ... March 24, 2017 , ... Shamanic healer and ... Shamanic Healing and Spiritual Awakening, proudly presents her Sacred Peru retreat with ... sacred and spiritual journey during the Summer Solstice will also be her final ...
(Date:3/24/2017)... ... March 24, 2017 , ... On June 9, 2017, Cassie ... Litigation seminar in Chicago, Illinois. She will present on: , Filing Benefit ... under ERISA involve claims for long-term disability benefits. This session will address ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... of enhancements, upgrading their training and leads programs. , In February, 2017, Empower ... elite sales agents, Performance Partners is designed to teach how to maximize their ...
(Date:3/24/2017)... ... March 24, 2017 , ... “Vintage and Harvest A ... minister and college Bible teacher residing in North Carolina with his wife, Anna Marie. ... blessed them with six grandchildren. David is also the author of “Shadow and Substance.” ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... 24, 2017 Research and Markets has ... U.S.: Consumer Strategies" report to their offering. ... Pain Management ... and treat their physical pain, emphasizing consumer survey analysis, including ... sufferers and adults who have selected illnesses/conditions strongly associated with ...
(Date:3/24/2017)... , March 24, 2017 FinancialBuzz.com ... ... leading publisher of cannabis market research, the legal cannabis market ... CAGR through 2021, despite conflicting signals from the current presidential ... out that the two biggest drivers of growth in this ...
(Date:3/24/2017)... , March 24, 2017 A ReportsnReports.com report ... been growing rapidly as the global sales of Adcetris and Kadcyla ... in the antibody drug conjugates market is driven by large number ... and wider therapeutic window offered by ADCs. ... Browse 3 Tables and 94 Figures, 10 ...
Breaking Medicine Technology: