Panacea Pharmaceuticals Announces Award of Phase II SBIR Grant for Pre-Clinical Development of Novel Drug to Treat Ischemic Stroke
June 21, 2006– Gaithersburg, Maryland – Panacea Pharmaceuticals,
Inc., today announced the award of a Phase II Small Business Innovation
Research (SBIR) grant of $880,000 from the National Heart, Lung
and Blood Institute of the U.S. National Institutes of Health
(NIH) to complete preclinical studies on a novel drug to treat
ischemic stroke. Results from a Phase I study confirmed that a
novel class of alpha (N) - heterocyclic carboxaldehyde thiosemicarbazones
(HCTs), demonstrates a powerful neuroprotective effect in animal
stroke models. Panacea has identified a lead compound, PAN-811,
and anticipates initiation of clinical trials in late 2007.
“We are excited about the potential of PAN-811 as a neuroprotective
agent,” commented Hossein Ghanbari, Ph.D., CEO and Chief
Scientific Officer at Panacea Pharmaceuticals. “The safety
of PAN-811 in humans has already been demonstrated, and we are
optimistic about its potential to significantly improve neurologic
function in individuals who have suffered a stroke. With no currently
available neuroprotective treatment alternatives for these patients,
PAN-811 could significantly improve outcomes and reduce the risk
of paralysis, loss of speech, and other complications associated
with stroke.”
About Stroke
A stroke occurs when the blood supply to part of the brain is
suddenly interrupted or when a blood vessel in the brain bursts.
Brain cells die when they no longer receive oxygen and nutrients
from the blood or there is sudden bleeding into or around the
brain. The symptoms of a stroke include sudden numbness or weakness,
especially on one side of the body; sudden confusion or trouble
speaking or understanding speech; sudden trouble seeing in one
or both eyes; sudden trouble with walking, dizziness, or loss
of balance or coordination; or sudden severe headache with no
known cause. There are two forms of stroke: ischemic
- blockage of a blood vessel supplying the brain, and hemorrhagic
- bleeding into or around the brain; 80 percent of strokes are
ischemic. Stroke is the third leading cause of death in the U.S.,
a major cause of long-term disability, and a significant burden
on public health worldwide. Currently, more than 4 million people
in the U.S are living with the consequences of stroke. Ischemia/hypoxia
as a result of stroke is a significant contributor to neurodegeneration,
manifest as paralysis, loss of speech, memory loss, and other
neurologic symptoms.
About PAN-811
PAN-811 is a small-molecule that fully blocks hypoxic and ischemic
neuronal cell death at a dose of 1 µM in vitro, and reduces
infarct volume by up to 59% in the middle cerebral artery occlusion
rat model of stroke. It manifests dual mechanistic functions including
both Ca2+ -chelation and free radical-scavenging (Zhi-Gang Jian,
X.C., et.al., A multifunctional cytoprotective agent that reduces
neurodegeneration after ischemia, PNAS, vol. 103, No. 5, 1581-1586,
2006). The toxicology and pharmacokinetics of the drug candidate
have been demonstrated and it is currently in Phase II clinical
trials at NIH for a cancer indication. Thus, at the end of the
Phase II SBIR study, Panacea expects to be in a position to begin
a Phase Ib human clinical trial to assess PAN-811 as a the treatment
of transient ischemic stroke.
About Panacea’s Oncology Platform
Panacea is also pursuing the development of antibodies directed
against Human aspartyl (asparaginyl) ß-hydroxylase (HAAH)
as novel agents for the treatment of cancer, with liver cancer
as its first intended indication. The Company is exploring both
naked anti-HAAH antibodies, as well as antibody conjugates with
various chemotherapeutic agents as lead candidates. Panacea is
also pursuing the development of diagnostic products based on
anti-HAAH antibodies. A proprietary blood-based assay has shown
high sensitivity and specificity in the detection of a range of
cancers and responsiveness to chemotherapy, thus allowing utility
in the diagnosis and therapeutic management of disease. Initial
targets for the HAAH diagnostic products include prostate and
liver cancers, along with tests to determine responsiveness to
a current therapy of choice in patients with Chronic Myelogenous
Leukemia. Panacea anticipates the initiation of its diagnostic
testing services later in 2006.
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,
and acute and chronic neurodegenerative conditions, such as hypoxia-induced
neurological insult, Parkinson’s disease, and Alzheimer’s
disease. Panacea’s neurodegenerative and oncology technologies
are each covered by one or more patents or patent applications.
More 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.
Contact:
Panacea Pharmaceuticals, Inc.
Kasra Ghanbari
Phone 240-243-8000 x107; FAX 240-465-0450
kasra@panaceapharma.com