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Peregrine Pharmaceuticals Reports Positive Phase Ib Results For Its Targeted Immunotherapy Bavituximab In Chronic Hepatitis C Infection
Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM), a biopharmaceutical company
developing targeted therapeutics for the treatment of cancer and hepatitis
C virus (HCV) infection, today reported preliminary top-line results from a
Phase lb study of its targeted immunotherapy bavituximab in patients with
chronic HCV infection. The repeat dose, multi-center open label study was
designed to assess the safety, distribution and pharmacokinetic properties
of four ascending dose levels of bavituximab administered as twice-weekly
monotherapy in HCV patients. The results indicate that Peregrine's novel
immunotherapeutic drug was generally safe and well tolerated, with no dose
limiting toxicities or serious adverse events reported. The preliminary
results also indicate that bavituximab showed positive signs of dose
dependent anti-viral activity.
Eliot W. Godofsky M.D., a principal investigator of the Phase Ib study
and director of the University Hepatitis Center in Sarasota, Florida, noted
these findings set the stage for testing bavituximab in combination with
other antiviral therapies: "As a targeted immunotherapy, bavituximab
represents an entirely new approach to treating chronic HCV infection.
Current HCV immunotherapies, such as interferon, act by stimulating a
general hyper-immune response, which can cause significant side effects in
many patients. In contrast, bavituximab has the potential to specifically
target HCV infected cells for destruction by the immune system. The key
findings of this repeat dose trial confirm our findings from the Phase 1a
study showing that bavituximab is generally safe and well tolerated in HCV
patients, with good signs of anti-viral activity. Based on these positive
results, we are looking forward to working with Peregrine to proceed to
trials that will further assess bavituximab's potential for the treatment
of chronic HCV infection."
In contrast to antiviral therapies, which attack hepatitis C viral
particles, bavituximab primarily works by homing in on a specific molecular
target that is expressed only on certain stressed cells, including both HCV
viral particles and patient cells infected with HCV. These infected patient
cells produce new viral particles that can cause the disease to reoccur.
Bavituximab flags these infected cells for destruction by the immune
system, enabling a highly targeted immune response. When used in
combination with antiviral drugs that lower virus levels, bavituximab may
have the potential to help permanently eradicate the HCV infection by
eliminating the infected cells that fuel disease resurgence.
The Phase lb study results indicate that 83% of patients at the 3
milligram per kilogram (mg/kg) dose level showed at least a 75% (0.6 log)
reduction or better in HCV RNA levels, with an average of an 84% (0.8 log)
reduction for the entire cohort. In this cohort, 50% of the patients showed
signs of greater antiviral activity, with an average HCV RNA load reduction
of 1 log. Patients showing signs of antiviral activity typically achieved
peak viral load reduction three to seven days after the initial dose. The
signs of antiviral activity in this repeat dose study compare favorably
with results previously reported for bavituximab administered as a single
dose infusion, with a higher percentage of patients in the current study
showing signs of antiviral activity with a similar safety profile. Based on
these positive data, Peregrine plans to advance bavituximab into new HCV
trials, including combination therapy and additional dosing studies
shortly.
"These results are particularly significant since they represent an
important milestone in Peregrine's efforts to develop targeted
immunotherapeutics, which are already transforming therapy for diseases
such as cancer, for life threatening viral infections including HCV," said
Steven W. King, president and CEO of Peregrine. "We believe that our
targeted immunotherapy agent bavituximab has the potential to change the
way HCV infections are treated, and we are delighted with the promising
safety results and positive signs of antiviral activity observed in this
repeat dose study. These results and the pharmacokinetic data also
generated by the study should be of great value as we finalize patient
dosing schedules for our next series of HCV clinical trials."
Mr. King added, "There are currently many new approaches in development
to treat chronic HCV infection that are aimed at directly inhibiting
production of the virus. All of these agents are being tested in
combination with various forms of interferon, which act by causing a
general stimulation of the immune system, resulting in toxic effects for
many patients. To achieve sustained antiviral responses with a regimen that
is both effective and safe, we need new immunotherapy agents that can work
with antiviral drugs to reduce or eliminate the need for these non-specific
immunotherapies. We believe bavituximab could be just this sort of agent,
targeting the immune system to act precisely where it is needed, with the
promise of reducing or eliminating the need for general immune stimulators
with their high potential for adverse effects."
In the Phase lb study, 24 patients were enrolled in four cohorts, with
each cohort receiving four doses of bavituximab over a 10-day period.
Patients received bavituximab at escalating dose levels of 0.3, 1, 3, or 6
mg/kg of body weight, and were followed for 12 weeks. All patients in the
study suffered from chronic HCV infection based on their medical history
and the presence of detectable serum HCV RNA. More than half of the study
cohort had genotype 1 HCV. This study included treatment naive patients as
well as partial responders and those who had either failed to respond to,
or relapsed after, standard-of-care HCV treatment.
"Combination regimens are a mainstay of hepatitis C treatments, and as
a clinician treating patients with chronic HCV infection, I am acutely
aware of the need for new agents that could minimize the toxicities we
currently see with the interferon-based component of these regimens," said
Dr. Eric J. Lawitz, a principal investigator of the Phase lb study and
director of Alamo Medical Research. "Bavituximab has a novel targeted
immunomodulatory mechanism that we hope will be complementary to emerging
new antiviral therapies for HCV infection. During this first multi-dose
trial, we found bavituximab was well tolerated, and we look forward to
additional trials that will help us understand the role that bavituximab
may play in the HCV treatment paradigms now in development."
Mr. King concluded, "We are encouraged that in these initial studies,
bavituximab's targeted mechanism shows signs of fewer side effects than is
typical of conventional immunotherapy with interferon, while as
monotherapy-- as expected--it is comparable to existing immunotherapies as
measured by viral load reductions. We believe that these positive findings
from our Phase lb study confirm that bavituximab may have the potential to
meet the pressing need for safe and effective immunotherapy agents for
patients with chronic HCV, and we also believe it may have the potential to
help eradicate chronic HCV in patients when used in combination with
antiviral drugs. We look forward to assessing these parameters in
combination therapy HCV trials in the near future."
Planning for dose optimization and combination therapy HCV studies is
nearly complete and several new bavituximab HCV studies are expected to
begin shortly.
About Bavituximab
Bavituximab is the first investigational agent in a new class of anti-
phosphotidylserine (PS) immunotherapeutics that targets and binds to
cellular components that are normally not present on the outside of cells,
but which become exposed on certain virally infected cells and on the
surface of enveloped viruses. Bavituximab helps stimulate the body's immune
defenses to destroy both the virus particles and the infected cells.
Bavituximab has completed two Phase l trials for the treatment of chronic
hepatitis C infection, and results from the Phase la study were presented
at the American Association for the Study of Liver Disease annual meeting
in late 2006. Similar to the proposed anti-viral mechanism,
anti-phospholipid immunotherapeutic agents also bind to phospholipids
exposed on tumor blood vessels in all solid cancers tested to date, and
they have shown promise in a number of preclinical cancer models.
Bavituximab is currently in two Phase l clinical trials for the treatment
of advanced refractory solid cancers.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a
portfolio of innovative product candidates in clinical trials for the
treatment of cancer and HCV infection. The company is pursuing five
separate clinical trials in cancer and HCV infection in the U.S. and India
with its lead product candidates bavituximab and Cotara(R). Peregrine also
has in- house manufacturing capabilities through its wholly owned
subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides
development and bio- manufacturing services for both Peregrine and outside
customers. Additional information about Peregrine can be found at
http://www.peregrineinc.com.
Safe Harbor Statement:
Statements in this press release which are not purely historical,
including statements regarding Peregrine Pharmaceutical's intentions,
hopes, beliefs, expectations, representations, projections, plans or
predictions of the future are forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. The
forward-looking statements involve risks and uncertainties including, but
not limited to, the risk that bavituximab's safety profile in a combination
therapy trial will not be at the same safety level as was found in the
phase 1b trial, the risk that the results of future trials will not
correlate to the results from the phase 1b trial, and the uncertainties as
to whether bavituximab will reduce or eliminate the need for general immune
stimulators or eradicate chronic HCV when used in combination with
antiviral drugs. Factors that could cause actual results to differ
materially include, but are not limited to, uncertainties associated with
completing preclinical and clinical trials for our technologies; the early
stage of product development; the significant costs to develop our products
as all of our products are currently in development, preclinical studies or
clinical trials; obtaining additional financing to support our operations
and the development of our products; obtaining regulatory approval for our
technologies; anticipated timing of regulatory filings and the potential
success in gaining regulatory approval and complying with governmental
regulations applicable to our business. Our business could be affected by
all a number of other factors, including the risk factors listed from time
to time in the Company's SEC reports including, but not limited to, the
annual report on Form 10-K for the year ended April 30, 2006, and the
quarterly report on Form 10-Q for the quarter ended October 31, 2006. The
Company cautions investors not to place undue reliance on the forward-
looking statements contained in this press release. Peregrine
Pharmaceuticals Inc. disclaims any obligation, and does not undertake to
update or revise any forward-looking statements in this press release.
Peregrine Pharmaceuticals
http://www.peregrineinc.com
Strãin produse farmaceutice rapoarte pozitive de fazã Ib Rezultate pentru imunoterapie Bavituximab sale orientate în infecþia cu hepatitã cronicã C - Peregrine Pharmaceuticals Reports Positive Phase Ib Results For Its Targeted Immunotherapy Bavituximab In Chronic Hepatitis C Infection - articole medicale engleza - startsanatate