- Median Survival of Study Patients is 12.7 Months -
ORLANDO, Fla., May 14 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) today announced that preliminary data from a Phase 2 study
involving 112 patients with stage IV metastatic melanoma showed a 12.7-month
median survival for patients treated with Vitaxin alone. The data also showed
a 9.4-month median survival for patients treated with Vitaxin plus dacarbazine
(DTIC). In a recent Phase 3 trial, patients treated with DTIC alone, the
current standard of care in advanced melanoma, had a median survival of 7.9
"From the data reported thus far, Vitaxin appears to have an acceptable
safety profile and to prolong survival for patients with metastatic melanoma
compared to what has been reported with standard therapy for this disease,"
said Dirk Reitsma, M.D., vice president, clinical development, oncology. "We
intend to collect and analyze the final data set, and to review these findings
with our advisory board and the Food & Drug Administration (FDA) as we
determine our next steps in developing Vitaxin as a potential cancer therapy."
Vitaxin is MedImmune's development-stage monoclonal antibody (MAb)
currently being evaluated in separate trials involving patients with advanced
melanoma and prostate cancers. The data from the melanoma trial were presented
at the 41st American Society of Clinical Oncology (ASCO) Annual Meeting in
Results from the Melanoma Study
The preliminary study data demonstrated that one-year survival rate was 53
percent for patients receiving Vitaxin alone (n=57), while the one-year
survival rate was 42 percent for patients receiving Vitaxin plus DTIC (n=55).
Twelve-months' data on three patients are still pending, two of these patients
are in the Vitaxin alone arm. The median survival of the 112 patients was
12.7 months for those receiving Vitaxin alone, and 9.4 months for those
patients receiving Vitaxin plus DTIC. Both arms of this study compare
favorably to data reported for patients receiving DTIC alone (n=385), which
was a control arm in a recently completed Phase 3 trial of Genasense(R)
(oblimersen sodium), presented on May 3, 2004 at the FDA Oncology Drug
Advisory Committee Meeting. In this separate trial, median survival for
patients receiving DTIC alone was 7.9 months and it is estimated from this
trial that approximately one-third of patients were alive at 12 months.
MedImmune's Phase 2 melanoma trial is a randomized, open-label study
conducted at more than 20 sites in the United States, Australia and the United
Kingdom. In the study, 112 patients with stage IV metastatic melanoma received
weekly intravenous infusions of Vitaxin at a dose of 8.0 mg/kg either alone or
in conjunction with 1,000 milligram per meter squared DTIC once every three
weeks. To date, safety data suggest that Vitaxin has been generally well
tolerated in these patients. Immunogenicity data are pending.
"I am excited to see the potential of Vitaxin used as a single agent for
patients with metastatic melanoma," said Peter Hersey, M.D., conjoint
professor of oncology, Newcastle Melanoma Unit, Australia, and presenter of
the data at ASCO. "If the results from this Phase 2 study can be replicated in
a controlled, pivotal study, Vitaxin might prove to be a major advance in the
treatment of advanced melanoma, a disease where the only existing options have
minimal therapeutic activity and considerable toxicity."
The title of the poster presented today at the ASCO meeting is "A Phase 2,
Randomized, Open-Label Study Evaluating the Antitumor Activity of MEDI- 522, a
Humanized Monoclonal Antibody Directed Against the Human Alpha v Beta 3 (avb3)
Integrin, plus or minus Dacarbazine (DTIC) in Patients with Metastatic
Malignant melanoma, the most serious form of skin cancer, is now the tenth
most common 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.
Vitaxin 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. In addition to the Phase 2 trial in advanced melanoma,
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.
About MedImmune, Inc.
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 approximately 2,000 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 that involve risks and uncertainties, in
particular, related to the research and development of Vitaxin. Such
statements reflect management's current views and are based on certain
assumptions. Actual results could differ materially from those currently
anticipated as a result of a number of factors, including risks and
uncertainties discussed in MedImmune's filings with the U.S. Securities and
Exchange Commission. There can be no assurance that such development efforts
will succeed, that Vitaxin will receive required regulatory clearance or, even
if such regulatory clearance is received, that Vitaxin will ultimately achieve
ASCO Abstract #7507
SOURCE MedImmune, Inc.
Media - Jamie Lacey
Investors - Peter Vozzo