AVAX Technologies Announces Initiation of Clinical Study with Autologous Ovarian Cancer Vaccine (OVax(R))
09 Avril 2008 - 2:46PM
Business Wire
AVAX Technologies, Inc. (OTC Market:AVXT.OB) today announces it has
received FDA approval to begin enrollment into a Phase I-II
clinical trial of OVax for patients with advanced,
chemotherapy-refractive ovarian cancer. The study will be performed
in collaboration with Cancer Treatment Centers of America, Inc
(CTCA). It will be centered in the CTCA hospital in Zion, Illinois,
although patients also will be referred from other CTCA hospitals
in Tulsa and Philadelphia, and its out-patient clinic in Seattle.
Up to 42 eligible patients with stage III or IV ovarian carcinoma
will be enrolled. These patients� cancers will have progressed
despite initial surgery and chemotherapy and failed to respond to
one or two salvage chemotherapy regimens. They will undergo
debulking surgery, and tumor tissue will be sent to AVAX for
production of vaccine. Post-operatively, they will receive
intraperitoneal chemotherapy with a taxane and then will be
enrolled into the protocol. Three doses of OVax will be tested, and
each of the three doses will be analyzed for immunological efficacy
with the goal of optimizing the dose for treatment of patients in
future trials. �We are enthusiastic about receiving FDA clearance
to start this important clinical trial and with the opportunity it
affords us to collaborate with CTCA,� stated Dr. David Berd, Chief
Medical Officer of AVAX. �Clearly, better treatments for ovarian
cancer are needed and we hope that OVax will eventually find its
place as a relatively non-toxic therapeutic alternative for these
patients. This alliance with CTCA will allow us to expand the
therapeutic utility of the AC�Vaccine platform along with our
ongoing Phase I/II program in non-small cell lung cancer and our
recently launched Phase III pivotal registration study in melanoma
(MVALDI).� As part of the business collaboration CTCA has made an
up-front payment of $250,000 and will begin to make monthly
payments of $25,000 upon the initiation of production of vaccines
at AVAX�s Philadelphia manufacturing facility. �We are very excited
to be part of a new chapter in the fight against ovarian cancer,�
said Dr. Edgar Staren, Chief Medical Officer at Cancer Treatment
Centers of America. �Ovarian cancer is a very complex cancer that
is often resistant to chemotherapy, radiation and surgery. At
Cancer Treatment Centers of America, our commitment to cancer
patients is to help fight their cancer with the most advanced
medical technology available. This partnership with AVAX gives hope
to ovarian cancer patients who are told far too often that there is
nothing more that can be done for them. This treatment option will
work well with our unique integrative care model that combines
state-of-the-art traditional medicine with scientifically-based
complementary therapies such as aggressive nutritional management
and support, naturopathic medicine, physical therapy, mind-body
medicine and spiritual support to go beyond treating the tumor and
supporting the needs of the whole person � all under one roof.�
About the AC Vaccine Therapeutic The AC Vaccine is an immunotherapy
prepared by attaching a small chemical to the patient�s tumor cells
in a process known as haptenization. This hapten modification
allows the tumor cells to stimulate a T cell-based immune response
to a patients own tumor cells. An early indicator of T cell immune
activity is Delayed Type Hypersensitivity (DTH). An understanding
of what AVAX calls the immunopharmacology of the AC Vaccines is
critical to their effective use. AVAX believes that the optimal
dose, schedule of administration, and route of administration of
human cancer vaccines must be established before they enter
advanced phase studies, and that some competing vaccine
technologies have failed because their developers ignored one or
more of these parameters in early phase development. The optimum
schedule and best route of administration (intradermal) to be used
for OVax were determined by extensive phase I-II studies of MVax.
The latest phase I-II trial was completed last year and the results
will be presented at the 2008 meeting of the American Society of
Clinical Oncology (ASCO). MVax Phase III Registration Study AVAX�s
Phase III Registration, MVALDI Trial will examine survival and
anti-tumor response rate using modified response evaluation
criteria in solid tumors (modified RECIST criteria) in Stage IV
melanoma patients with soft tissue or lung metastasis. The Phase
III registration trial is being conducted under a Special Protocol
Assessment (SPA) agreement with the U.S. Food and Drug
Administration (FDA) for MVax and in agreement with the FDA the
company will be eligible to file for accelerated approval of MVax
based upon achieving a response rate endpoint. The double blind,
randomized trial is expected to enroll up to 387 patients to be
accrued over a period of 24 months. Patients will be randomized on
a two to one basis to the treatment arm or control arm,
respectively. The treatment arm consists of MVax followed by a
regimen of low dose interleukin-2 (IL-2); the control arm consists
of placebo vaccine followed by low dose IL-2. Both treatment and
control arms include BCG and low dose cyclophosphamide. About
Ovarian Cancer The American Cancer Society reports that ovarian
cancer is the eighth most common cancer among women and is the
fifth leading cause of cancer related deaths in women. It is
estimated that there will be 21,650 new cases of ovarian caner in
the U.S. in 2008 and 15,520 cancer related deaths. Two-thirds of
the cases of Ovarian Cancer will occur in women over 55. About
Cancer Treatment Centers of America Founded in 1988, Cancer
Treatment Centers of America (CTCA) provides a comprehensive,
patient-centered treatment model that fully integrates traditional,
state-of-the-art medical treatments with scientifically-supported
complementary therapies such as nutrition, naturopathic medicine,
psycho-social counseling, physical therapy and spiritual support to
meet the special, whole-person needs of cancer patients living with
complex and advanced-stage disease. With a network of cancer
treatment hospitals and community oncology programs in Illinois,
Oklahoma, Pennsylvania and Washington, CTCA encourages patients and
their families to participate in treatment decisions with its
Patient Empowerment MedicineSM model. For more information about
Cancer Treatment Centers of America, go to cancercenter.com. About
AVAX Technologies, Inc. AVAX Technologies, Inc. is a biotechnology
company with operations in the United States and Europe. The
Company is engaged in the research, clinical and commercial
development of biological products and cancer therapeutics. AVAX�s
AC Vaccine platform is a therapeutic cancer vaccine. In addition,
the Company performs contract-manufacturing services for biological
products for other pharmaceutical and biotechnology companies.
Except for statements that are historical, the statements in this
release are "forward-looking" statements that are made pursuant to
the safe harbor provisions of Section 27A of the Securities Act of
1933 and Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements involve significant risks and
uncertainties, and in light of the significant uncertainties
inherent in such statements, the inclusion of such information
should not be regarded as a representation by AVAX that the
objectives and plans of the Company will be achieved. In fact,
actual results could differ materially from those contemplated by
such forward-looking statements. Many important factors affect the
Company's prospects, including (1) risk associated with a change in
executive management of the Company, (2) the immediate need to
obtain additional funding to continue to finance the Company�s
development plans, including the Phase I-II clinical trial for OVax
described in this press release, (3) the results of clinical and
laboratory testing of its vaccine technologies, (4) possible future
FDA or AFSSAPS questions regarding the Company's products and
manufacturing processes, (5) exchange rate risks associated with
financing the Company in U.S. dollars but funding significant
operating expenses in Europe with Euro�s, (6) the Company's ability
to maintain its rights under license agreements and to meet funding
requirements under its license agreements, (7) the Company's
ability to demonstrate the safety and efficacy of product
candidates at each stage of development and to meet applicable
regulatory standards and receive required regulatory approvals, as
well as other risks detailed from time to time in AVAX's public
disclosure filings with the Securities and Exchange Commission,
including its Annual Report on Form 10-KSB. AVAX does not undertake
any obligation to release publicly any revisions to these
forward-looking statements or to reflect the occurrence of
unanticipated events.
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