GAITHERSBURG, Md., Dec. 5 /PRNewswire/ -- Panacea Pharmaceuticals, Inc.
announced today the selection of PAN-622 -- a fully human sequence
monoclonal antibody against HAAH -- as its lead cancer therapeutic product.
Developed in collaboration with the Massachusetts Institute of Technology,
PAN-622 has demonstrated high affinity and excellent efficacy in animal
models of cancer. Having a fully human sequence, PAN-622 is anticipated to
have significantly fewer adverse effects compared to chimeric or humanized
monoclonal antibodies. Initial human clinical trials with PAN-622 are
anticipated to begin in early 2009.
Human Aspartyl (Asparaginyl) Beta-Hydroxylase (HAAH) is an enzyme that
modulates signaling factors such as Notch, and is over-expressed in
malignant cells. HAAH is present specifically on the cancer cell surface
and on the infiltrating edge of tumors; surface expression of HAAH also
makes it accessible to drugs or antibodies that are not capable of crossing
cellular membranes. Alterations in cellular function due to its
overexpression and translocalization are consistent with the cancer
phenotype, and include increased cellular proliferation, motility and
invasiveness. When HAAH expression is silenced in cancer cells or its
enzymatic activity is neutralized on the cell surface, the cancer cells
revert to a normal phenotype. HAAH overexpression and its surface
expression has been detected in more than 20 different cancer types and in
>99% of all tumor samples tested to date (n > 1000). HAAH is not present in
significant amounts in adjacent non- transformed tissue as well as normal
tissue (n > 500). Therapeutics directed against HAAH, particularly
monoclonal antibodies, are likely to be effective in treating a broad range
of cancers with minimal adverse effects.
In vitro, Panacea has shown that monoclonal antibodies against HAAH
inhibit cell growth in a dose-dependent fashion, inhibit cell motility more
than 6-fold and reduce invasion from 26% to 0.1%. Similarly, in a xenograft
model of human liver cancer, anti-HAAH antibodies inhibited tumor growth in
all animals, with 40% showing no visible tumor. In an animal model of
metastatic human colon cancer, treatment with anti-HAAH antibodies inhibits
metastasis. To date, PAN-622 has demonstrated the best performance in
xenograft models of human liver cancer as measured by inhibition of tumor
growth, and thus has been selected as Panacea's lead anti-cancer drug
candidate. In recent experiments, nude mice were injected subcutaneously
with a human liver cancer cell line and tumors were allowed to grow for 3
days prior to the initiation of treatment. Animals were treated three times
per week with PAN-622 or a non-relevant human IgG for four weeks. Mice were
observed for a three weeks after the cessation of treatment. PAN-622
inhibited tumor growth in all animals by about 90%, with 40% showing no
visible tumor. Tumors did not re-grow in these animals in the period after
treatment cessation.
"PAN-622 has demonstrated excellent inhibition of tumor growth in
animal models of cancer, and as a cancer-specific therapeutic, should have
a low toxicity and adverse effect profile," commented Hossein Ghanbari,
Ph.D, Founder, Chairman, CEO and CSO at Panacea Pharmaceuticals. "We are
confident that the performance of PAN-622 in animals will be replicated in
humans, and quite excited about the potential for this product to
effectively treat a broad range of cancers."
HAAH was discovered by researchers at Brown University and the Rhode
Island Hospital. Panacea holds worldwide exclusive rights to develop and
commercialize therapeutic and diagnostic products based on HAAH, and as
such owns the rights to PAN-622. PAN-622 is manufactured in high yield
under cGMP guidelines, and should enter Phase 1 clinical trials in early
2009 with an initial indication for the treatment of hepatocellular
carcinoma.
About Panacea's Oncology Platform
In addition to the cancer therapeutic PAN-622, Panacea offers: PC
Detect(sm), a diagnostic test used in conjunction with PSA and digital
rectal exam to identify patients with prostate cancer; LC Detect(sm), a
diagnostic test to aide in the detection of patients with lung cancer; BC
Detect(sm), a diagnostic test to aide in the detection of recurrence of
breast cancer; CC Detect(sm), a diagnostic test to aide in the detection of
colo-rectal cancer; and TK Sense(sm), which determines whether white blood
cells from patients with chronic myelogenous leukemia (CML) are sensitive
or resistant to imatinib, the therapy of first choice for CML patients,
prior to initiation of therapy. Each of these tests is offered as a
laboratory service performed by Panacea Laboratories
(http://www.panacea-labs.com), a division of Panacea Pharmaceuticals, Inc.
About Panacea Pharmaceuticals, Inc.
Panacea Pharmaceuticals, Inc. is a privately-held biopharmaceutical
company focused on the development and commercialization of therapeutics
and diagnostics for diseases with substantial, unmet clinical needs. The
Company's product development strategy is based on novel therapeutic agents
and approaches for cancer treatment, as well as acute and chronic
neurodegenerative conditions, such as hypoxia-induced neurological insult,
Parkinson's Disease, and Alzheimer's Disease. Panacea has an extensive
patent portfolio covering its neurodegenerative and oncology technologies.
Panacea Laboratories is a division of Panacea Pharmaceuticals, Inc.
Additional information about the Company is available at
http://www.PanaceaPharma.com.
Except for historical information presented in this press release,
matters discussed herein may constitute "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995.
Forward- looking statements are based on the opinions and estimates of
management only as of the date of this release and are subject to certain
risks and uncertainties that could cause actual results to differ
materially from any future results, performance, or achievements expressed
or implied by such statements. Factors that might cause such a difference
include, but are not limited to, uncertainties related to our access to
capital, the progress, costs, and results of any clinical trials undertaken
by us, progress of our research and development projects, and uncertainties
related to whether our product candidates would ultimately achieve
commercial success. We do not undertake any obligation to update publicly
any forward-looking statement, whether as a result of new information,
future events, or otherwise unless required by law.
SOURCE Panacea Pharmaceuticals, Inc.
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Related links:
http://www.panaceapharma.com
http://www.panacea-labs.com
CONTACT:
Stephen N. Keith, MD, MSPH, President & COO
of Panacea Pharmaceuticals, Inc., +1-240-243-8000, fax,
+1-240-465-0450, skeith@panaceapharma.com
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