FREMONT, Calif., July 19 /PRNewswire/ -- Abgenix, Inc. (Nasdaq: ABGX)
announced today that it has filed an IND to initiate a Phase I clinical trial
in cancer with its proprietary fully human monoclonal antibody, ABX-EGF. The
multi-center, multi-dose, dose escalating trial is expected to involve
approximately 30 patients suffering from various types of cancer. Developed
using the company's XenoMouse(TM) technology, ABX-EGF targets the receptor for
human epidermal growth factor (EGFr) which is overexpressed on many major
human tumors types including renal, prostate, lung, and breast. Another
member of the EGFr family, Her-2, is the target for a monoclonal antibody
currently being marketed by Genentech, Inc. for treatment of breast cancer.
Cancer cells often become dependent on growth signals mediated through the
EGFr for their survival. Such cells typically exhibit a significantly
increased level of EGFr expression. ABX-EGF binds with high affinity to EGFr
and selectively targets these cancer cells by blocking the binding of
important tumor growth factors to the receptor. As reported in Cancer Research
(Volume 59, Issue no. 6) in a paper titled, "Eradication of Established Tumors
by a Fully Human Monoclonal Antibody to the Epidermal Growth Factor Receptor
without Concomitant Chemotherapy," Abgenix scientists demonstrated that
ABX-EGF alone, in mouse models, can eradicate established tumors, can block
the growth of human tumors, and is potent at comparatively low doses. A key
finding of the Abgenix studies was that relatively low doses of ABX-EGF,
without concomitant chemotherapy, could eradicate human tumors at sizes up to
1.2cm(3) in mice. Although the treatment period was relatively short, no
recurrence of tumors was seen in these mice at 250 days after the last dose of
antibody.
"We believe that antibody-based therapies have the potential to become
important tools in treating various cancers," stated R. Scott Greer, president
and chief executive officer of Abgenix. "In the United States there are now
two therapeutic antibody products marketed for the treatment of cancer and
several others targeting cancer are in advanced stages of clinical
development."
As a fully human antibody generated with XenoMouse(TM) technology, ABX-EGF
is expected to have minimal immunogenicity and a longer half-life than
antibody products containing mouse protein, thus potentially allowing repeat
administration at lower doses and longer intervals in patients with competent
immune systems. This potential was observed in a Phase I clinical trial in
psoriasis of ABX-IL8, the first fully human antibody generated in transgenic
mice to be tested in humans. ABX-IL8 demonstrated a half life of
approximately three weeks, equivalent to that of naturally occurring human
antibodies and no immune reaction to ABX-IL8 was observed.
Abgenix is a biopharmaceutical company that develops and intends to
commercialize antibody therapeutic products for the treatment of a variety of
disease conditions, including transplant-related diseases, inflammatory and
autoimmune disorders, cardiovascular disease and cancer. Abgenix has developed
XenoMouse technology, which it believes enables quick generation of high
affinity, fully human antibody product candidates to essentially any disease
target appropriate for antibody therapy. Abgenix has collaborative
arrangements with multiple pharmaceutical and biotechnology companies
involving its XenoMouse technology. In addition, Abgenix has four proprietary
antibody product candidates that are under development internally, two of
which are in human clinical trials.
Statements made in this press release about the potential of ABX-EGF and
other antibody-based therapies as treatments for various cancers, Abgenix's
XenoMouse technology, product development activities and collaborative
arrangements other than statements of historical fact, are forward looking
statements and are subject to a number of uncertainties that could cause
actual results to differ materially from the statements made, including risks
associated with the success of clinical trials, the progress of research and
product development programs, the regulatory approval process, competitive
products, future capital requirements and the extent and breadth of Abgenix's
patent portfolio. Please see Abgenix's public filings with the Securities and
Exchange Commission for information about risks which may affect Abgenix.
SOURCE Abgenix, Inc.
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Related links:
http://www.abgenix.com
CONTACT:
Kurt Leutzinger, Vice President and Chief
Financial Officer of Abgenix, 510-608-6575; or Stephanie Seiler,
Ph.D., 212-696-4455 ext. 212, or Amy Flood, 415-677-4455 ext.
211, both of Noonan Russo Communications, for Abgenix
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