Navigation Links
IDM Pharma Announces Updated Phase 3 Mifamurtide (L-MTP-PE) Data Confirms Statistically Superior Overall Survival in Osteosarcoma Patients
Date:11/1/2007

e are currently in the process of amending the L-MTP-PE New Drug Application with more complete long-term survival data from the same study, with the goal of obtaining regulatory approval and bringing L-MTP-PE to the patients who haven't had an improvement in treatment outcomes for the last 20 years."

Study design and findings

The multicenter, open label, randomized, factorial, four parallel treatment group Phase 3 study evaluated the effects of the addition of L-MTP-PE to chemotherapy in patients with resectable osteosarcoma without metastatic disease. There were 672 with newly diagnosed, non-metastatic, resectable osteosarcoma included in the COG analyses.

In the analyses by the COG investigators, Event Free Survival (EFS), including secondary malignancies, after six years in patients treated with chemotherapy and L-MTP-PE was 67%, compared to 61% in patients treated only with chemotherapy and no L-MTP-PE (p=0.08). Overall Survival (OS) after six years in patients treated with chemotherapy and L-MTP-PE was 78%, compared to 70% in patients treated only with chemotherapy and no L-MTP-PE (p=0.03).

Treatment with L-MTP-PE was generally well tolerated in all phases of study. Adverse events were mild to moderate in severity and included chills, fever, nausea, vomiting, myalgia, headache, tachycardia (fast heart rate), hypo- and hypertension, fatigue and shortness of breath, all of which are consistent events with the activation of monocytes and macrophages by L-MTP-PE and the flu-like symptoms that follow cytokine release. These side effects are readily prevented or treated with acetaminophen or ibuprofen.

L-MTP-PE Regulatory Status

The L-MTP-PE New Drug Application (NDA) includes efficacy and safety data from 678 patients with non-metastatic resectable osteosarcoma, 332 of whom received L-MTP-PE, and from 115 patients with metastatic or unresectable osteosarcoma, 39 of whom received L-MTP-PE, in the controlled Phase 3 trial conducted
'/>"/>

SOURCE IDM Pharma, Inc.
Copyright©2007 PR Newswire.
All rights reserved

1

GOOD

Page: 1 2 3 4 5 6

Related medicine technology :

1. Sygnis Pharma AG announces date for presentation of clinical results
2. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
3. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
4. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
7. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
8. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
9. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
10. Array BioPharma to Present at the C.E Unterbeg, Towbin Emerging Growth Conference
11. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/18/2010)... , March 18 Ahead of World ... Margaret Hamburg helped public and private sector partners ... of combination treatments for tuberculosis — and replace an ... for TB Drug Development, the Critical Path Institute, and ...
(Date:3/17/2010)... 17 DURECT Corporation (Nasdaq: DRRX ) announced today that Matt Hogan , Chief Financial Officer, will be presenting at the Barclays Capital Global Healthcare ... ... , , ... ...
(Date:3/17/2010)... Early Show .  New York physician Dr. Jon Turk introduced the breakthrough treatment to millions of viewers as the bridge between facial fillers and surgical facelifts.   ... ... ... ...
Breaking Medicine Technology:Global Partners Join Forces to Speed Development of New TB Drug Combinations 2Global Partners Join Forces to Speed Development of New TB Drug Combinations 3Global Partners Join Forces to Speed Development of New TB Drug Combinations 4Global Partners Join Forces to Speed Development of New TB Drug Combinations 5Global Partners Join Forces to Speed Development of New TB Drug Combinations 6DURECT to Present at the Barclays Capital Global Healthcare Conference 2DURECT to Present at the Barclays Capital Global Healthcare Conference 3'The AccuLift Phenomenon' Kicks off on CBS' The Early Show 2'The AccuLift Phenomenon' Kicks off on CBS' The Early Show 3Embryology study offers clues to birth defects 8775 1Embryology study offers clues to birth defects 8775 2Clock Ticking In Boston Archdiocese Abortion Scandal 48361 1Clock Ticking In Boston Archdiocese Abortion Scandal 48361 2Apria Healthcare Awards Technology Solutions Contract to Perot Systems 48359 1Apria Healthcare Awards Technology Solutions Contract to Perot Systems 48359 2Apria Healthcare Awards Technology Solutions Contract to Perot Systems 48359 3
... analysis from ATHENA Study showed that Multaq(R) on ... of hospital days,by 28% in patients with atrial ... New data from the,landmark ATHENA trial showed ... of hospital stays among patients with atrial,fibrillation/atrial flutter ...
... Remission / Unconfirmed Complete Remission Rate 3.5 Fold Higher ... Compared to Standard ... and MTA: CTIC) announced today that it achieved the primary,efficacy ... for patients with advanced, relapsed aggressive non-Hodgkin,s,lymphoma (NHL) based on ...
Other Medicine Technology:Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation 2Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation 3Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation 4Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation 5Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation 6Cell Therapeutics' Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint 2Cell Therapeutics' Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint 3Cell Therapeutics' Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint 4
(Date:3/21/2010)... "Tonight,s historic vote marks a major milestone in the ... and provide quality, affordable health care for millions of ... leadership of President Barack Obama and Speaker ... necessary to defeat the special interests and do what ... remember those who stood with us and those who ...
(Date:3/21/2010)... WASHINGTON, March 22, 2010 NPR,s Car Talk guys, ... motor mouths, but they always put a lid on ... confirm their serious commitment to addressing the issue of ... by teaming with the University of Utah to launch ... cartalk.com/distraction . , The center, sponsored by Allstate, ...
(Date:3/21/2010)... Lifts, will now buy back used lifts from AmeriGlide or Summit, make ... , ... (Vocus) March 21, 2010 -- 4 Stair Lifts has announced ... lifts from AmeriGlide and Summit. The company will buy them back ... are working correctly before putting them on sale at discounted prices., , ...
(Date:3/21/2010)... 2010 With stomach irritation preventing almost 2 out ... reported discovery of several substances that may be among ... pain in every cup. , Their report, presented ... Chemical Society, included the counter-intuitive finding that espresso, French ... the tummy because these roasts contain a substance that ...
(Date:3/21/2010)... from Charmaine Yoest , President & CEO of Americans United for Life Action: , ... , ... ... ... "This deal to pass the largest expansion of abortion since Roe v. Wade is a tragedy for America.  We believe ...
Breaking Medicine News(10 mins):Health News:'A Monumentally Important Victory for Our Country' 2Health News:Driver safety Web site from Car Talk, U of Utah 2Health News:4 Stair Lifts Announces Used Stair Lift Buy Back Program 2Health News:Brewing up a gentler java: Dark-roasted coffee contains stomach-friendly ingredient 2Health News:Brewing up a gentler java: Dark-roasted coffee contains stomach-friendly ingredient 3
... Air Pollution While EPA Shirks Responsibility , , ... TODAY released their study of schools where the outside air poses ... school staff. The study identified 435 schools in "toxic hot ... what the Center for Health, Environment and Justice (CHEJ) has been ...
... WASHINGTON, Dec. 8 The independent, non-profit, ... medical records for every doctor,s office and hospital ... key elements of which were announced as part ... Address ( http://change.gov/newsroom/entry/the_key_parts_of_the_jobs_plan/ ). , ...
... December 8 - 14; Urges Immunization into December, January and ... D.C., Dec. 8 Mothers -- often the family,s primary ... their families vaccinated against influenza throughout the winter months and ... the American Lung Association as part of its Faces ...
... Traumatic Injury Protection Program Expands Benefits , ... Veterans Affairs (VA) announced some severely injured military personnel and ... Life Insurance Traumatic Injury Protection Program, known as TSGLI . ... was created to relieve some of the financial burdens on ...
... for men with a family history of the disease, researchers say ... men living with a significant other are more prone to get ... The study, published in Cancer Epidemiology, Biomarkers & Prevention ... cancer were 40 percent less likely to be screened if they ...
... 8 Screening with an ultrasound machine has ... with sickle cell disease, by identifying children who ... an eight-year period at The Children,s Hospital of ... ultrasonography (TCD), along with regular transfusions for children ...
Other Medicine News:Health News:If Your Child Says School Makes Him Sick - He Might Be Right 2Health News:eHealth Initiative Applaudes President-Elect Obama's Recognition of the Importance of Information Technology to Improve U.S. Health Care System 2Health News:Survey Shows Mothers See Value in Influenza Vaccination for Their Families Through the Winter and Spring 2Health News:Survey Shows Mothers See Value in Influenza Vaccination for Their Families Through the Winter and Spring 3Health News:Survey Shows Mothers See Value in Influenza Vaccination for Their Families Through the Winter and Spring 4Health News:Survey Shows Mothers See Value in Influenza Vaccination for Their Families Through the Winter and Spring 5Health News:VA Announces Changes to Servicemembers' Group Life Insurance 2Health News:Ultrasound Screening Helps Prevent Stroke in Children With Sickle Cell Disease 2Health News:Ultrasound Screening Helps Prevent Stroke in Children With Sickle Cell Disease 3
Surgitie&trade Single Use Ligating Loops with Delivery System...
Surgitie&trade Single Use Ligating Loops with Delivery System...
Surgitie&trade Single Use Ligating Loops with Delivery System...
ENDO STITCH&trade Triple-Stitch Single Use Loading Units for use with ENDO Stitch* 10 mm Suturing Device....
Medicine Products: