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IDM Pharma's MEPACT(R) (Mifamurtide, L-MTP-PE) Receives Approval in Europe for Treatment of Patients with Non-Metastatic, Resectable Osteosarcoma

First New Agent Approved to Treat Osteosarcoma in More Than 20 Years IRVINE, Calif., March 9 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI ) today announced that the European Commission has formally granted a Centralized marketing authorization for MEPACT(R) (mifamurtide, L-MTP...

NCCN Announces Updates to Pancreatic Adenocarcinoma Guidelines

...equivocal CT findings) patients considered to have resectable disease at presentation. Laparoscopy is also recom...er neoadjuvant therapy in patients with borderline resectable disease, prior to laparotomy. Another import...nsus of the panel members which defines borderline resectable disease. Dr. Tempero also provided additiona...

Immune-based drug approved in Europe for pediatric cancer patients

...opean 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 Cen...

First Patient from CyberKnife Center of Palm Beach Enrolled in Worldwide Landmark Study of Operable Lung Cancer Patients

... has been enrolled in the landmark study comparing traditional surgery and CyberKnife® radiosurgery treatment outcomes in early stage operable and resectable lung cancer. The randomized, prospective clinical study, led by University of Texas M. D. Anderson Cancer Center in Houston, Texas, will eval...

Radiation before surgery improves pancreatic cancer outcomes

...jor study that has suggested that neoadjuvant radiation had any distinct advantage over postoperative radiation in terms of survival for patients with resectable tumors. In this retrospective analysis, Dr. Sherr -- along with Weill Cornell Graduate School of Medical Sciences student Alexander Stessin and New...

Sanofi-aventis: Encouraging First-Quarter 2008 Results Further Positive Phase III Results for Eplivanserin

...progression-free survival compared to surgery alone when given perioperatively (before and after surgery) to colorectal cancer patients with initially resectable liver metastases. Net sales of Tritace(R), affected by competition from generics in Canada and Europe, fell by 34.9% to EURO 138 million. Net sale...

Post-Op Chemo Fails to Boost Survival in Stomach Cancers

...in patients with localized gastric cancer, said Dr. Aiwen Wu and Dr. Jiafu Ji. "Surgery alone is no longer the standard treatment for patients with resectable gastric cancer, independent of the patient population or the practice location," they wrote. More information The American Cancer Society has ...

IDM Pharma Reports Third Quarter 2007 Financial Results

...DA) 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 met...effectiveness of L-MTP-PE in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy. In July 2007, following a ...

IDM Pharma Announces Data Presentation From Mifamurtide (L-MTP-PE) Compassionate Use Program

... or recurrent disease, locally or metastatic, with resectable or not completely resectable disease, or who are u... safety data from 678 patients with non-metastatic resectable osteosarcoma, 332 of whom received L-MTP-PE, and f... in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy. I...

Three Chemo Drugs Better Than Two for Advanced Head/Neck Cancers

... the volunteers had any signs of cancer in areas far from the original tumor site. Posner said his study included people who had both unresectable and resectable tumors. The study participants were randomly assigned to receive the standard two-drug regimen (cisplatin and fluorouracil) or the new three-drug t...
Resectable in Medical Technology

Perioperative Eloxatin(R)-Based Regimen Significantly Reduced the Risk of Relapse Versus Surgery Alone in Eligible Colorectal Cancer Patients with Initially Resectable Liver Metastases

- EPOC Results Published in March 22 Issue of The Lancet - BRIDGEWATER, N.J., March 20 /PRNewswire-FirstCall/ -- Sanofi-aventis today announced that efficacy results of the randomized phase III EORTC 40983 Intergroup study published in the March 22 issue of The Lancet showed that in eli...

The Eloxatin-Based Regimen (FOLFOX4) Significantly Improved Progression Free Survival When Given Before and After Surgery in Patients With Resectable Liver Metastases From Colorectal Cancer

Presentation at ASCO Plenary Session Reports EORTC 40983 (EPOC) Intergroup Study Results CHICAGO, June 04, 2007 /PRNewswire-FirstCall/ -- Results of the randomized phase III EORTC 40983 Intergroup study, or EPOC study, demonstrate for the first time that peri-operative (pre and post surgery) FOLFO...

IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP)

... CHMP considered the Company's Marketing Authorization Application (MAA) for mifamurtide (L-MTP-PE) for the treatment of patients with non-metastatic, resectable osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults. Based on discussions at that meeting, the Company ...

FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids

...e ExAblate(R) 2000 system utilizing MR-guided Focused Ultrasound Surgery (MRgFUS) for the enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids who are diagnosed with unexplained infertility. Twenty U.S. and international sites will enroll a total of 650 women with uterine f...

IDM Pharma Announces Updated Data From Mifamurtide (L-MTP-PE) Compassionate Access Program

... 8, 2008). 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 ...

IDM Pharma Announces Availability of Mifamurtide (L-MTP-PE) Through Compassionate Access Study

...steosarcoma 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 toxi...

IDM Pharma Announces Phase 3 Mifamurtide (L-MTP-PE) Study Demonstrating Improved Survival Published in the Journal of Clinical Oncology

...ation (MAA) for L-MTP-PE for the treatment of patients with non-metastatic, resectable osteosarcoma. Updated results from this study were previously presented at ...doxorubicin, methotrexate, and ifosfamide) in patients with newly diagnosed resectable osteosarcoma without metastatic disease. Patients received one of four pr...

IDM Pharma Announces Non-Binding Opinion of the European Committee for Medicinal Products for Human Use (CHMP) that Mifamurtide (L-MTP-PE) Provides a Possible Clinical Benefit in Survival

...n Agency (EMEA), regarding the Marketing Authorization Application (MAA) for mifamurtide (L-MTP-PE) for the treatment of patients with non-metastatic, resectable osteosarcoma. L-MTP-PE was granted orphan drug status in Europe in 2004. The Marketing Authorization Application for L-MTP-PE was submitted to the EME...

IDM Pharma Announces Updated Phase 3 Mifamurtide (L-MTP-PE) Data Confirms Statistically Superior Overall Survival in Osteosarcoma Patients

...ition of L-MTP-PE to chemotherapy in patients with resectable osteosarcoma without metastatic disease. There wer... safety data from 678 patients with non-metastatic resectable osteosarcoma, 332 of whom received L-MTP-PE, and f... in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy. I...

Coley Pharmaceutical Group Receives $3.0 Million Milestone Payment from GlaxoSmithKline

... MAGRIT trial (MAGE- A3 as Adjuvant Non-Small Cell Lung Cancer Immunotherapy) will target enrollment of about 2,270 patients with stage IB, II or IIIA resectable NSCLC. The primary endpoint of the trial is disease-free survival. The $3 million development milestone was triggered by the initiation of this Phase ...
Resectable in Biological Technology

Horizon Therapeutics Names Dr. Jeffrey W. Sherman Executive Vice President and Chief Medical Officer

...al, regulatory, and development teams that secured European Commission approval for MEPACT(R) (mifamurtide, L-MTP-PE), a treatment for non-metastatic, resectable osteosarcoma. Prior to IDM Pharma, Dr. Sherman served as vice president of clinical science at Takeda Global Research & Development Center, Inc.,...

IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma

...nternational): 4467870 About the mifamurtide (L-MTP-PE) NDA The L-MTP-PE 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 ...
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