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

by the Pediatric Oncology Group (POG) and the Children's Cancer Group (CCG), now the Children's Oncology Group (COG), sponsored by the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute. Also included are safety and efficacy data from 51 patients with metastatic osteosarcoma treated in earlier Phase 2 studies. The biological effects and safety of L-MTP-PE are further supported by data from 7 other Phase 1 and 2 clinical studies performed under IND, in which an additional 197 patients received at least one dose of L-MTP-PE.

L-MTP-PE was granted orphan drug status in the United States in 2001. The NDA for L-MTP-PE was submitted to the U.S. Food and Drug Administration (FDA) in October 2006 and was accepted for review in December 2006.

The FDA's Oncologic Drugs Advisory Committee, or ODAC, met in May 2007 and voted 12 to 2 that the results of the Company's Phase 3 trial do not provide substantial evidence of effectiveness of L-MTP-PE in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy. In July 2007, following a meeting with the FDA, the Company announced that it would collect, analyze and submit additional data for L-MTP-PE to the FDA, in an amendment to the NDA, by the first quarter of 2008. In August 2007 the FDA, considering ODAC's recommendation, issued a not approvable letter to the Company after completing the review of the NDA for L-MTP-PE. In this letter, the FDA requested data from additional clinical trials to demonstrate the benefit of L-MTP-PE, as well as information or clarification with respect to other sections of the NDA.

IDM Pharma also is seeking marketing approval from the European Medicines Agency (EMEA) for the use of L-MTP-PE, or MEPACT as it is known in Europe. L-MTP-PE was granted orphan drug status in Europe in 2004. The Marketing Authorization Application (MAA) for L-MTP-PE was submitted to the EMEA and accepted for review in November 2006. The E
'/>"/>

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

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:8/29/2014)... Calif. , Aug. 29, 2014 Medina ... as CEO and member of the Board of Directors ... of medical device development and commercialization experience, including over ... Mr. Engelson previously served as a Partner of the ... President and CEO of two Foundry start-ups. Mr. Engelson ...
(Date:8/29/2014)... 29, 2014 Research and Markets ... Instrument Industry Report, 2014-2017" report to their offering. ... rising proportion of reimbursement for medical expenses, the Chinese ... its scale presenting a CAGR of 19.2% during 2009-2013. ... product segments of orthopedic instruments in China ...
(Date:8/29/2014)... , August 29, 2014 ... Seed Oil Market by Extraction type (SFE, Cold ... & Personal Care, Pharmaceutical, Food Supplements, Fragrance, & Others) ... by MarketsandMarkets, defines and segments the Amaranth Seed ... the market size in terms of value. The ...
Breaking Medicine Technology:Medina Medical Announces Erik T. Engelson Joins as Chief Executive Officer 2China Orthopedic Instrument Industry Report, 2014-2017 2Amaranth Seed Oil Market worth $700.6 Million by 2019 2Amaranth Seed Oil Market worth $700.6 Million by 2019 3Amaranth Seed Oil Market worth $700.6 Million by 2019 4
... NASHVILLE, Tenn., May 4, 2011 Cumberland Pharmaceuticals Inc. ... focused on hospital acute care and gastroenterology markets, today announced ...   For the three months ended March 31, 2011, net ... corresponding period in 2010. Revenue grew year-over-year despite a brief, ...
... May 4, 2011The U.S. Food and Drug Administration ... manufacture, market, or distribute over-the-counter (OTC) liquid drug ... to measure and dispense the doses of medication. ... The guidance, titled Dosage Delivery Devices for ...
Cached Medicine Technology:Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results 2Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results 3Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results 4Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results 5Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results 6Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results 7Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results 8Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results 9Cumberland Pharmaceuticals Reports First Quarter 2011 Financial Results 10FDA Issues Final Guidance for Liquid OTC Drug Products With Dispensing Devices 2FDA Issues Final Guidance for Liquid OTC Drug Products With Dispensing Devices 3
(Date:8/30/2014)... 30, 2014 Serving contented clients since ... Profit By Outsourcing is now offering discount for ... company gives emphasize on putting forward the best of ... clients. Their dedicated team of professionals and web developers ... can handle even the critical issues of web development ...
(Date:8/30/2014)... Saturday 30 August 2014: Transvenous lead extraction (TLE) ... according to data from the European Lead Extraction ConTRolled ... ESC Congress 2014 by Dr Maria Grazia Bongiorni, chair ... "The number of cardiac implantable electronic devices (CIED) implant ... technology the number of complications has increased and leads ...
(Date:8/30/2014)... 2014 Top10BestSEOHosting.com is a well-known ... announced that HostGator.com http://secure.hostgator.com/~affiliat/cgi-bin/affiliates/clickthru.cgi?id=seohosts is the ... Also, they has announced that Bluehost and Arvixe ... Hostgator, one of the Top 10 Web Hosting ... Windows hosting, and it offers rich features and ...
(Date:8/30/2014)... LiveStreamingFitness.com, a company dedicated to providing live at ... is proud to announce it has been recognized as one ... solutions by ABC’s Good Morning America. , ... Morning America, “Live Streaming Fitness is the hottest new trend ... streamlining your workout…to boot camp at Life Streaming Fitness for ...
(Date:8/30/2014)... McLeod's Sunset Park Auto Service , a family owned ... to the community celebrates sixty years in business. In addition, ... chosen by The Tampa Tribune’s readers again as ... McLeod’s father, Norris (most know him as Mac) opened McLeod's ... Tim runs the day to day, taking on the family ...
Breaking Medicine News(10 mins):Health News:Profit By Outsourcing Offering Discount for Labor Day on all Web Development Services 2Health News:Transvenous lead extraction clinically successful in 98 percent of cases 2Health News:Transvenous lead extraction clinically successful in 98 percent of cases 3Health News:Top10BestSEOHosting.com: HostGator.com Is The Best Windows Hosting Supplier 2Health News:LiveStreamingFitness.com is New Trend In Fitness 2Health News:McLeod's Sunset Park Auto Service Celebrates 60 Years Honored with Best of South Tampa 2
... Royer Animal Health, LLC, a wholly owned subsidiary ... agreement with MWI Veterinary, Supply, Inc. (Nasdaq: ... MATRIX III CISPLATIN BEADS and R-GEL ... products provide veterinary professionals with localized treatment options for ...
... of protests in Washington urging inclusion of the Community ... Impact points to the success of existing community-based, affordable ... number of those who need more intense health care ... million people with disabilities in the U.S., there is ...
... SCOTT DEPOT, W.Va., April 30 International Coal Group, Inc. (NYSE: ... the lead Pink Ribbon sponsor for the 2009 Susan G. Komen ... is scheduled to start at 9 a.m. in front of the ... honors the late Susan G. Komen, who died of breast cancer ...
... 30 SynCare, LLC, today announced it was awarded ... HealthCare USA members in Missouri. HealthCare USA engaged SynCare ... membership into appropriate case management programs.HealthCare USA is a ... Medicaid and SCHIP members. Their mission is to improve ...
... The Providence Service Corporation (Nasdaq: PRSC ... results for its first quarter ended March 31, 2009 on ... a conference call at 11:00 a.m. EDT (9:00 a.m. MDT ... to discuss its financial results and corporate developments. Interested ...
... McEntee praises Obama request for $1.5 billion in additional ... union survey of more than 100 health care facilities ... prepared to protect workers, health and safety during an ... In Peril: Preparing to Protect Worker Health and Safety ...
Cached Medicine News:Health News:Royer Animal Health Enters Into Exclusive Agreement With MWI Veterinary Supply for U.S. Distribution of Next-Generation Therapeutics to Treat Cancer and Infections 2Health News:Community Approach Necessary For Affordable Long-Term Care, Says NCB Capital Impact 2Health News:SynCare, LLC(TM) Awarded HealthCare USA Health Risk Assessments Contract 2Health News:Providence Service Corporation to Report First Quarter 2009 Results on Wednesday, May 6th After the Market Closes 2Health News:Providence Service Corporation to Report First Quarter 2009 Results on Wednesday, May 6th After the Market Closes 3Health News:Union Survey on Influenza Pandemic Finds Lack of Adequate Health and Safety Measures for Health Care Workers 2Health News:Union Survey on Influenza Pandemic Finds Lack of Adequate Health and Safety Measures for Health Care Workers 3
Two 2.75 mm long tips separated 1 mm with 1 x 2 teeth. Serrated handle with dull finish....
Colibri style tips with 0.12 mm, 1 x 2 teeth. Round knurled handle with alignment pin and polished finish....
Titanium. 0.12 mm 1 x 2 teeth with 6 mm platform and 2.0 mm angled tips. Flat serrated handle, dull finish....
0.4 mm, 1 x 2 teeth 7 mm tying platform. Serrated handle with polished finish....
Medicine Products: