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IDM Pharma Announces Phase 3 Mifamurtide (L-MTP-PE) Study Demonstrating Improved Survival Published In The Journal Of Clinical Oncology
IDM Pharma, Inc.
(Nasdaq: IDMI) announced the Journal of Clinical Oncology (JCO) has
published findings from the Phase 3 mifamurtide (L-MTP-PE) clinical trial
(INT-0133), entitled "Osteosarcoma: The Addition of Muramyl Tripeptide to
Chemotherapy Improves Overall Survival - A Report from the Children's
Oncology Group." The landmark clinical trial, which is the largest study
completed in this disease was a National Cancer Institute (NCI) funded
cooperative group study conducted by the Children's Oncology Group (COG).
The COG's findings were based on long-term follow up of 662 patients
with newly diagnosed non-metastatic osteosarcoma treated in the Phase 3
trial and demonstrated that the addition of L-MTP-PE to chemotherapy
following surgery resulted in statistically superior Overall Survival (OS)
the first stated aim of the study.
In the past two decades, there have been no treatment advances for
patients with osteosarcoma, a rare and often fatal bone tumor that
typically affects children and young adults.
"L-MTP-PE in combination with chemotherapy has demonstrated a
significant long-term overall survival advantage in the largest Phase 3
clinical trial completed in patients with osteosarcoma," said Dr. Paul
Meyers, vice chair, department of pediatrics at Memorial Sloan-Kettering
Cancer Center and principal investigator of the Phase 3 trial. "These
results are encouraging for children and young adults with osteosarcoma,
considering the lack of progress for these patients in the last 20 years."
The JCO publication highlighting long-term follow up from this study
formed the basis of the recent oral explanation to the Committee for
Medicinal Products for Human Use (CHMP), the scientific committee of the
European Medicines Agency (EMEA), regarding the Marketing Authorization
Application (MAA) for L-MTP-PE for the treatment of patients with
non-metastatic, resectable osteosarcoma. Updated results from this study
were previously presented at the Connective Tissue Oncology Society (CTOS)
annual meeting in November 2007. In addition, the new JCO publication
highlights the long-term OS data whereas a prior JCO publication in 2005
focused on an Event Free Survival (EFS) additional analysis.
"These findings of statistically superior overall survival in long-term
patient follow-up validate the survival benefit offered by L-MTP-PE and
underscore the desperate need for new treatments for osteosarcoma
patients," said Timothy P. Walbert, president and chief executive officer,
IDM Pharma. "We believe these findings were critical to the recent opinion
from the Committee for Medicinal Products for Human Use in Europe and are a
positive step toward bringing this important treatment to the European
market and potentially gaining approval in the United States."
Study design and findings
The multicenter, open label, randomized, factorial, four parallel
treatment group Phase 3 study was designed to evaluate the effects of
patient outcome of the addition of L-MTP-PE to three-drug chemotherapy
(cisplatin, doxorubicin, and methotrexate) or four-drug-chemotherapy
(cisplatin, doxorubicin, methotrexate, and ifosfamide) in patients with
newly diagnosed resectable osteosarcoma without metastatic disease.
Patients received one of four prospectively randomized treatments and
all patients received identical cumulative doses of cisplatin, doxorubicin,
and methotrexate and underwent definitive surgical resection of primary
tumor. Patients were randomly assigned to receive or not to receive
ifosfamide and/or MTP in a 2x2 factorial design.
In the published analysis, the chemotherapy regimens without L-MTP-PE
resulted in similar OS and EFS. Overall Survival after six years of
follow-up in patients treated with chemotherapy and L-MTP-PE was 78%,
compared to 70% in patients treated only with chemotherapy (p=0.03). The
addition of L-MTP-PE to chemotherapy resulted in approximately 30% decrease
in the risk of death. EFS, an additional analysis which includes the
occurrence of secondary malignancies, after six years of follow-up in
patients treated with chemotherapy and L-MTP-PE was 67% compared to 61% in
patients treated only with chemotherapy (p=0.08).
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.
L-MTP-PE Regulatory Status
The Company recently announced that following presentation of data at
an oral explanation hearing before the CHMP, the Committee determined in a
non-binding opinion that L-MTPE-PE suggested a possible clinical benefit in
terms of survival and granted the Company a clock stop, or time extension.
The clock stop will allow the Company additional time to respond to all the
remaining questions regarding the MAA.
The CHMP has requested clarification of the existing data in order to
gain assurance about the quality of the data before drawing any final
conclusions from the data presented. In addition, the Company is required
to address a number of remaining questions relating to chemistry,
manufacturing and controls (CMC). The Company now expects to receive a
final opinion from the CHMP in the third quarter and a final decision from
the European Commission in the fourth quarter of 2008.
L-MTP-PE was granted orphan drug status in Europe in 2004. The MAA for
L-MTP-PE was submitted to the EMEA and accepted for review in November
2006.
As previously announced, in the United States the Company continues to
work with COG as well as external experts and advisors to gather patient
follow up data from the Phase 3 clinical trial of L-MTP-PE conducted by COG
and to respond to other questions in the not approvable letter the Company
received from the U.S. Food and Drug Administration (FDA).
L-MTP-PE was granted orphan drug status in the United States in 2001.
The new drug application (NDA) for L-MTP-PE was submitted to FDA in October
2006 and was accepted for review in December 2006.
About Osteosarcoma
About 3 percent of all childhood cancers are osteosarcoma. Because
osteosarcoma usually develops from osteoblasts, it most commonly affects
children and young adults experiencing their adolescent growth spurt. Boys
and girls have a similar incidence rate until later in their adolescence,
when boys are more commonly affected. While most tumors occur in larger
bones, such as the femur, tibia, and humerus, and in the area of the bone
that has the fastest growth rate, they can occur in any bone. The most
common symptom is pain, but swelling and limited movement can occur as the
tumor grows.
Osteosarcoma is an orphan disease with fewer than 1,000 new cases
diagnosed in the U.S. each year. A similar incidence of the disease exists
in Europe. According to the Children's Oncology Group, the survival of
children with osteosarcoma has remained at 60-65 percent since the
mid-1980s. The standard treatment for osteosarcoma is tumor resection with
combination chemotherapy before and after surgery.
About IDM Pharma
IDM Pharma is focused on the development of innovative cancer products
that either destroy cancer cells by activating the immune system or prevent
tumor recurrence by triggering a specific adaptive immune response. IDM
Pharma is dedicated to maximizing the full therapeutic and commercial
potential of each of its innovative products to address the needs of
patients and the physicians who treat these patients.
For more information about the company and its products, visit
http://www.idm-pharma.com.
Forward-Looking Statements
This press release includes forward-looking statements that reflect
management's current views of future events including statements regarding
the significance of COG's findings that L-MTP-PE, in combination with
chemotherapy, has demonstrated a significant long-term overall survival
advantage based on long-term patient follow-up, the effect such findings
may have on the Company's ability to obtain regulatory approval of L-MTP-PE
in Europe and the United States, the pathway to a potential positive
opinion from the CHMP based on the CHMP's non-binding opinion regarding the
clinical benefit in survival of L-MTP-PE, the Company's plans to address
the remaining questions with respect to the MAA during the time extension
or clock-stop granted by the CHMP, and the expected timing of a final
opinion from the CHMP and of a final regulatory decision regarding the MAA
in the European Union, as well as the Company's plans to collect, analyze
and submit additional Phase 3 data in an amended NDA for L-MTP-PE and to
respond to other matters raised by the FDA and timing for preparation of
the NDA amendment. Actual results may differ materially from the
forward-looking statements due to a number of important factors, including,
but not limited to, whether the Company will be able to provide assurance
regarding the quality of the existing data and to respond to the remaining
issues with regard to the MAA, including verification of data quality and
chemistry, manufacturing and controls (CMC) items, in a satisfactory manner
during the extension provided by the CHMP, whether the final opinion of the
CHMP will be consistent with the non-binding opinion of the CHMP, whether
the European Commission will follow the final opinion of the CHMP once
issued, whether the likely timing for the final opinion of the CHMP and the
regulatory decision in Europe will occur as expected by the Company, the
possibility that the Company may not be able to collect, analyze and submit
additional data in an amendment to the NDA for L-MTP-PE within the
timeframe expected by the Company, if at all, the possibility that such
data will not support the benefit of L-MTP-PE in the treatment of
non-metastatic osteosarcoma, will not allow a more robust analysis of
L-MTP-PE, will not continue to support its overall survival benefit in
osteosarcoma, and may not provide substantial evidence for the potential
regulatory approval of L-MTP-PE, the timing of the FDA's and EMEA's review
of the submissions for marketing approval of L-MTP-PE, the ability of the
Company to respond to questions raised by the FDA and EMEA in a
satisfactory manner, the time needed to respond to any issues raised by the
FDA and EMEA with regard to regulatory submissions for L-MTP-PE, the
possibility that regulatory authorities may not consider preclinical and
early clinical development work conducted by Ciba-Geigy and efficacy data
from the Phase 3 trial conducted by Children's Oncology Group as adequate
for their assessment of L-MTP-PE, which may cause delays in review, may
result in the regulatory authorities requiring the Company to conduct
additional clinical trials, or may result in a determination by the
regulatory authorities that the data does not support marketing approval,
whether regulatory authorities will approve L-MTP-PE within the time frame
expected by the Company or at all, and whether the Company will be able to
manufacture and commercialize L-MTP-PE even if it is approved by regulatory
authorities. Other risks affecting the Company and its drug development
programs include whether the Company or any of its collaborators will be
able to develop pharmaceutical products using the technologies of the
Company, whether clinical trial results to date are predictive of results
of any future clinical trials, risks associated with completing clinical
trials of product candidates, risks involved in the regulatory approval
process for the Company's product candidates, the possibility that clinical
testing may reveal undesirable and unintended side effects or other
characteristics that may prevent or limit the commercial use of proposed
products; whether the cash resources of the Company will be sufficient to
fund operations as planned, including any further clinical trials of any of
the Company's product candidates; whether any steps taken by the Company to
contain costs will in fact result in sufficient reduction in expenses;
reliance on key employees, especially senior management; the risk that the
Company may not secure or maintain relationships with collaborators, and
the Company's dependence on intellectual property. These factors are more
fully discussed in the Company's Quarterly Report on Form 10-Q filed with
the SEC for the quarter ended September 30, 2007 and other periodic reports
filed with the SEC. The Company expressly disclaims any intent or
obligation to update these forward-looking statements, except as required
by law.
IDM Pharma, Inc.
http://www.idm-pharma.com
IDM Pharma anunta de fazã 3 Mifamurtide (L-MTP-pe) bunã a supravieþuirii, demonstrând studiu publicat în Jurnalul Oficial al clinice de oncologie - IDM Pharma Announces Phase 3 Mifamurtide (L-MTP-PE) Study Demonstrating Improved Survival Published In The Journal Of Clinical Oncology - articole medicale engleza - startsanatate