09.04.2008 12:46:00
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AVAX Technologies Announces Initiation of Clinical Study with Autologous Ovarian Cancer Vaccine (OVax(R))
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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