- Data Presented at the 44th American Society for Clinical Oncology (ASCO)
Annual Meeting -
IRVINE, Calif., June 2 /PRNewswire-FirstCall/ -- IDM Pharma, Inc.
(Nasdaq: IDMI) today announced the presentation of an analysis from the
Phase 3 mifamurtide (L-MTP-PE) clinical trial (INT-0133). The results
suggest that the addition of L-MTP-PE to chemotherapy improved overall
survival with a 25% reduction in the risk of death in newly diagnosed
patients with metastatic osteosarcoma, a rare and often fatal bone tumor
that typically affects children and young adults.
"These data in a difficult-to-treat metastatic patient population are
encouraging, especially given the limited treatment options available,"
said Timothy P. Walbert, president and chief executive officer, IDM Pharma.
"We continue to believe the data from non-metastatic patients in the
L-MTP-PE Phase 3 study warrants regulatory approval in Europe and the
United States and are optimistic that the overall survival benefit seen
with L-MTP-PE will be the clinical evidence needed to support bringing this
important treatment to market."
The Phase 3 L-MTP-PE trial (INT-0133) is National Cancer Institute
(NCI) funded cooperative group study conducted by the Children's Oncology
Group (COG) and is the largest study completed in osteosarcoma, enrolling
approximately 800 patients. The multicenter, open label, randomized,
factorial, four parallel treatment group Phase 3 study was designed to
evaluate patient outcomes with the addition of L-MTP-PE to adjuvant three-
or four-drug chemotherapy (cisplatin, doxorubicin, and methotrexate with or
without ifosfamide).
The analysis evaluated 91 newly diagnosed patients with metastatic
osteosarcoma who were treated with one of the chemotherapy regimens with or
without L-MTP-PE. At five-years the overall survival (OS) for patients who
received L-MTP-PE (n=46) was 53% versus 40% for those who did not receive
L-MTP-PE (n=45). Event-free survival (EFS) at five years for patients who
received L-MTP-PE was 42% versus 26% for those patients who did not receive
L-MTP-PE. While these results showed improvement, the subset was not
powered to show statistical significance due to the small sample size.
Update on L-MTP-PE Regulatory Status
In January 2008 the Company announced that following presentation of
data at an oral explanation hearing before the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency, the CHMP
determined in a non-binding opinion that L-MTP-PE suggested a possible
clinical benefit in terms of survival and granted the Company a clock stop,
or time extension. The clock stop allows the Company additional time to
respond to all the remaining questions regarding the marketing
authorization application for L-MTP-PE (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)
and the Company expects to provide responses and data regarding these
issues to the CHMP in advance of its meeting scheduled for June 23-26,
although the CHMP may have additional questions or require additional
information regarding these issues. In April, the European regulatory
authorities conducted an inspection of the Children's Oncology Group (COG)
to assess the quality of the overall survival data from the 2006
confirmatory database included in the Company's applications for regulatory
approval, and to review Good Clinical Practices compliance of COG in terms
of patient randomization and stratification, overall survival data
collection, and study monitoring. The Company supported the COG in this
effort.
The Company 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.
As previously announced, in the United States the Company continues to
work with the COG as well as external experts and advisors to gather
patient follow up data from the Phase 3 clinical trial of L-MTP-PE and to
respond to other questions in the non-approvable letter the Company
received from the U.S. Food and Drug Administration (FDA). The Company
expects to submit the amended New Drug Application (NDA) in the fourth
quarter of 2008.
L-MTP-PE was granted orphan drug status in the United States in 2001
and in Europe in 2004. In Europe, the MAA was filed in November 2006 and in
the U.S., the NDA was submitted to FDA in October 2006 and was accepted for
review in December 2006.
About Osteosarcoma
Between two and three 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 United States 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.
As previously announced, the Company is evaluating the Company's
research and development programs, including related assets and costs, and
strategic alternatives available to the Company.
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 the Company's belief
that the data from the L-MTP-PE Phase 3 study warrants regulatory approval
in Europe and the United States, the Company's plans to address the
remaining questions with respect to the MAA for L-MTP-PE during the
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, including
the expected timing for such amended NDA, and to respond to other matters
raised by the FDA and the Company's plans to evaluate strategic
alternatives. 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 respond to the remaining issues
with regard to the MAA, including verification of data quality and CMC
items, to the satisfaction of the CHMP, whether the CHMP will ask the
Company for further information at or following the June 2008 meeting to
address remaining issues with regard to the MAA, which would delay the
timing of a final opinion from 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 timing for the final opinion of the CHMP and the
regulatory decision in Europe will occur as expected by the Company, the
possibility that additional data from the Phase 3 clinical trial of
L-MTP-PE and other information in any amendment to the NDA for L-MTP-PE
submitted by the Company may not provide adequate support for regulatory
approval of L-MTP-PE in the United States within the timeframe expected by
the Company, if at all, whether the Company will be able to manufacture and
commercialize L-MTP-PE even if it is approved by regulatory authorities,
whether the Company will be able to complete any potential strategic
transaction on terms acceptable to the Company's stockholders, and whether
the cash resources of the Company will be sufficient to fund operations as
planned. These and other risks affecting the Company and its drug
development programs, intellectual property rights, personnel and business
are more fully discussed in the Company's Quarterly Report on Form 10-Q
filed with the SEC for the quarter ended March 31, 2008 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.
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Via: Healthcare
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