- MedImmune to Initiate Phase 3 Study with Metastatic Melanoma
Patients in 2006 -
GAITHERSBURG, Md., April 10 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that it has collected additional preclinical
and clinical data showing that Abegrin (formerly known as Vitaxin(R)) may
provide a three-pronged approach to treating solid tumors. The new data
provides additional insight into the drug's mechanism of action, which is
believed to inhibit tumor growth, bone metastases and angiogenesis. These data
support the encouraging overall survival results produced in a previously
announced Phase 2 trial with metastatic melanoma patients, and provide the
impetus for MedImmune to move ahead with a confirmatory Phase 3 trial for
Abegrin in patients with melanoma.
"We were encouraged by results of our Phase 2 study which suggested that
Abegrin may prolong survival in melanoma patients," said Dirk Reitsma, M.D.,
vice president, clinical development, oncology. "We have since acquired
additional supportive preclinical and clinical data, expanding our insight
into how Abegrin works. We are excited to begin planning a confirmatory Phase
3 study in a tumor type for which there are limited effective treatment
options, and anticipate initiating this trial late in 2006."
Data from several preclinical studies and two Phase 1 translational
clinical trials with Abegrin were presented recently at the 2006 annual
meeting of the American Association for Cancer Research (AACR) in Washington,
DC (April 1-5, 2006) and the Canadian Melanoma Conference in Banff, Alberta,
Canada (March 2-5, 2006). These studies incorporated the use of biomarkers,
imaging techniques, and pharmacologic and pharmacodynamic endpoints to help
determine the optimal dose of Abegrin. MedImmune researchers were interested
in gaining additional insight into how much alpha-v beta-3 is found in
particular tumors; how drug gets to the tumors (and how much drug gets there);
how tumor cells respond pharmacologically to Abegrin; and how blood levels of
Abegrin correlate to tumor saturation.
Results from the preclinical studies for Abegrin indicated that its
mechanism of anti-tumor action may involve both direct and indirect effects on
a tumor's ability to grow or spread. Data from these studies also suggest that
the majority of Abegrin's anti-tumor activity is likely mediated through
antibody-dependent cellular cytotoxicity (ADCC), and that the antibody does
not shrink tumors but does appear to slow progression. In addition, evaluation
of dose response in four in vivo tumor models demonstrated that peak
preclinical activity was achieved at comparable levels to those achieved in
the Phase 2 study, at a single dose of 8 mg/kg weekly.
The Phase 1 translational studies have been conducted to describe tumor
tissue saturation and biological activity of Abegrin. In the first trial,
conducted by the National Cancer Institute in patients with refractory solid
tumors, dynamic computed tomographic (CT) scans were used to assess changes in
tumor perfusion and blood flow. As published in Clinical Cancer Research in
November 2005, the data indicated that treatment with Abegrin decreased blood
flow through the tumors, and that there was possible clinical activity in
renal cell cancers at several dose levels. The objective of the second Phase 1
trial, which is still ongoing in patients with advanced melanoma, is to
identify the dose of Abegrin that saturates the targeted tumor tissue and
tumor blood vessels. Preliminary results from this study support prior
findings that saturation occurs at the 8 mg/kg dose level.
Abegrin is a monoclonal antibody that targets the alpha-v beta-3 integrin,
which is a protein expressed on the surface of newly forming blood vessels,
certain tumor types and on a number of other cell types, including macrophages
and osteoclasts. Based on preclinical models, the alpha-v beta-3 integrin has
been implicated in a number of disease processes, including the growth and
metastasis of tumors and bone degradation. A Phase 2 study involving 112
patients with stage IV metastatic melanoma showed a 12.7-month median survival
for patients treated with Abegrin alone and a 9.4-month median survival for
patients treated with Abegrin plus dacarbazine (DTIC), compared to an earlier
Phase 3 study in which patients treated with DTIC had a median survival of 7.9
months.(1) MedImmune is also currently conducting a Phase 2 trial in patients
with androgen-independent prostate cancer that has metastasized to bone. The
company completed enrolling 126 patients in this trial in April 2005.
Malignant melanoma, the most serious form of skin cancer, is now the tenth
most common cause of cancer in the U.S., responsible for nearly 80 percent of
all deaths from skin cancer. It is the fastest-rising form of cancer among men
and the second fastest form among women. Although five-year survival may
approach 85 percent for melanoma patients diagnosed at the earliest stage,
these rates decline precipitously once tumors have metastasized.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value to
shareholders. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on the areas of infectious diseases,
cancer and inflammatory diseases. With more than 2,200 employees worldwide,
MedImmune is headquartered in Maryland. For more information, visit the
company's website at http://www.medimmune.com.
(1) Data taken from the DTIC alone arm in the Genasense(R) Phase 3 trial
presented on May 3, 2004 at the FDA's Oncology Drug Advisory Committee
Meeting. Genasense is a registered trademark of Genta Inc.
This announcement contains, in addition to historical information, certain
"forward-looking statements" regarding the research and development of
Abegrin. Such forward-looking statements are based on current expectations
and involve inherent risks and uncertainties, including factors that could
delay, divert or change current expectations and could cause actual outcomes
and results to differ materially from current expectations. In addition to
risks and uncertainties discussed in MedImmune's filings with the U.S.
Securities and Exchange Commission, no assurance exists that development
efforts will succeed, that Abegrin will receive required regulatory approval
or that, even if regulatory approval is received, the product will be
commercially successful. MedImmune undertakes no obligation to update any
forward-looking statement, whether as a result of new information, future
events or otherwise except as may be required by applicable law or regulation.
SOURCE MedImmune, Inc.
CONTACT: Media: Kate Barrett, +1-301-398-4320, or Jamie Lacey,
+1-301-398-4035, Investors: Peter Vozzo, +1-301-398-4358, all of MedImmune,