PRCS files IND for Alzheimer's treatment (inhibition of beta-amyloid plaques), but they aren't alone. See the appended press release from Neurochem.
Does anyone have an opinion on these plaques being THE cause of Alzheimer's or are they correlates of another process that causes the damage? Are they necessary and sufficient or just necessary but not sufficient? I've seen articles indicating oxidative stress and advanced glycation endproducts may be involved.
Jason
Friday December 29, 7:00 am Eastern Time
Press Release
SOURCE: PRAECIS PHARMACEUTICALS INCORPORATED
PRAECIS PHARMACEUTICALS INCORPORATED
Announces Submission of Investigational New Drug Application for Alzheimer's
Disease Drug
CAMBRIDGE, Mass., Dec. 29 /PRNewswire/ -- PRAECIS PHARMACEUTICALS INCORPORATED (Nasdaq: PRCS - news)
today announced the submission to the U.S. Food and Drug Administration (FDA) of an Investigational New Drug
application (IND) to initiate Phase I clinical trials of Apan, its drug candidate in development for the treatment of Alzheimer's
disease.
Alzheimer's disease affects an estimated four million people in the United States and is expected to become increasingly
prevalent as the population ages. Current therapies provide temporary relief for some of the symptoms of Alzheimer's disease,
but do not affect the progression of the disease itself.
The hallmark of Alzheimer's disease is the accumulation of plaque-like deposits in brain tissue. A major component of this
plaque is a small peptide called beta-amyloid. A large body of clinical, biochemical and genetic evidence suggests that when
beta-amyloid molecules aggregate they become toxic to nerve cells, which leads to the development and progression of
Alzheimer's disease. Preclinical experiments have shown that Apan inhibits the aggregation of beta-amyloid and its associated
nerve cell toxicity. In addition, Apan reaches the brain in animals in quantities that the Company believes are sufficient to
block the aggregation of beta-amyloid molecules and alter the course of the disease.
Accumulation of beta-amyloid in the brain is often thought of as a defect in the ability to clear beta-amyloid from the brain
through the cerebral spinal fluid (CSF). Both humans and transgenic mice with Alzheimer's disease plaques show increased
levels of beta-amyloid in the brain and decreased levels in the CSF. Transgenic mice treated with Apan show significant
increases in beta-amyloid levels in the CSF, indicating that Apan is able to mobilize beta-amyloid in the brain and may be
facilitating its clearance.
PRAECIS expects to begin a normal volunteer, Phase I clinical trial of Apan during the first quarter of 2001, contingent upon
any additional requests from the FDA prior to the commencement of trials. The principal purpose of a Phase I trial is to
determine safety of a drug in human subjects.
PRAECIS PHARMACEUTICALS INCORPORATED is a biotechnology company focused on the discovery and development
of pharmaceutical products using its proprietary LEAP(TM) (Ligand Evolution to Active Pharmaceuticals) technology. LEAP
combines the power of biological selection with the advantages of medicinal chemistry in a unique molecular evolution
process. PRAECIS successfully employed LEAP in the development of abarelix depot, its lead candidate for the treatment of
prostate cancer and endometriosis. PRAECIS also has programs in Alzheimer's disease, pain management and AIDS.
This news release contains forward-looking statements, including, but not limited to, statements regarding the filing of an IND
for Apan, the regulatory review of that filing by the U.S. Food and Drug Administration and potential commencement of
clinical trials of Apan. These statements are based on PRAECIS' current beliefs and expectations as to future outcomes. Such
statements are subject to certain factors and uncertainties that may cause actual results to differ materially from expected
results. These include, but are not limited to, unexpected results in ongoing and future clinical trials, the need for additional
research and testing, delays in manufacturing, access to capital and funding, and the timing and content of decisions made by
the U.S. Food and Drug Administration, as well as the risks set forth from time to time in PRAECIS' filings with the Securities
and Exchange Commission, including but not limited to the risks discussed in PRAECIS' most recent Form 10-Q.
Contact: Investors - Kevin F. McLaughlin, Senior Vice President & Chief Financial Officer, 617-494-8400, ext. 2274,
kevin.mclaughlin@praecis.com; Media - Janice M. McCourt, Vice President of Operations & Director of Corporate
Communications, 617-494-8400, ext. 2330, janice.mccourt@praecis.com, both of PRAECIS PHARMACEUTICALS
INCORPORATED.
SOURCE: PRAECIS PHARMACEUTICALS INCORPORATED
=============================================
Tuesday December 5, 11:37 am Eastern Time
Press Release
SOURCE: Neurochem Inc.
Neurochem announces the achievement of an important
drug development milestone for Alzheimer's Disease
SAINT-LAURENT, QC, Dec. 5 /CNW/ - Neurochem Inc. (TSE : NRM - news) announced today the achievement of an
important drug development milestone for the advancement of an anti-amyloid drug candidate, for the treatment of
Alzheimer's Disease. In accordance with the ongoing collaborative agreement with H. Lundbeck A/S ("Lundbeck"), the
achievement of this milestone triggers a number of milestone and research support payments from Lundbeck including an
equity purchase of US $ 2.5 million.
"We are delighted with our agreement with Neurochem, a company that is very active within the area of amyloid research. In
the year of our partnership Neurochem has made significant progress in its development of a novel treatment for a
neurological disease, making this collaboration an excellent opportunity to help patients afflicted by Alzheimer's Disease,"
remarked Executive Vice-President R&D of Lundbeck Dr. Claus Braestrup. "We look forward to working closely with
Neurochem in the years to come."
In a "proof-of-concept" study, Neurochem's drug candidate was administered in genetically-engineered mice expressing the
human amyloid precursor protein (hAPP) to determine the curative potential of this drug candidate. The mice were developed
at the Centre for Research in Neurodegenerative Diseases at the University of Toronto (Canada). Using this aggressive hAPP
transgenic model of Alzheimer's Disease, a compound was shown to significantly reduce the number and size of brain amyloid
plaques , to decrease the inflammatory reaction in the brain and to maintain a higher survival rate in treated mice. Neurochem
anticipates submitting shortly the scientific findings for publication in a peer-reviewed journal.
A preliminary phase I single dose study with the compound in human volunteers has already provided information re.
tolerability and pharmacokinetics. Further, the compound has demonstrated a good safety and pharmacokinetic profile in
preclinical studies. The Company believes that this is the first time an oral drug candidate with a documented low toxicity
potential has been shown to reduce the development of amyloid plaque and inflammatory reactions in an animal model of
Alzheimer's Disease.
"These findings represent a very important step towards the further development of the compound as a therapeutic treatment
in Alzheimer's Disease. This milestone payment will further support the important drug development activities required to
advance this promising treatment of brain amyloidosis," said Dr. Louis R. Lamontagne, President & CEO of Neurochem.
"Lundbeck's expertise in the development of therapeutic treatments for major diseases of the central nervous system will be
instrumental to the on-going scientific and drug development activities for this novel class of potential therapeutic drugs."
About Lundbeck
H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production,
marketing and sale of drugs for the treatment of psychiatric and neurological diseases. The Company had consolidated net
turnover of DKK 4.2 billion in 1999 and employs approximately 3200 people. Further information is available at
www.lundbeck.com.
The Lundbeck group is headquartered at Ottiliavej 9, DK-2500 Valby, Copenhagen, Denmark. Tel. +45 3630 1311.
About Neurochem
Neurochem is a leader in the development of novel, proprietary compounds that inhibit the formation, deposition and toxic
effects of amyloid fibrils within the body. Neurochem's research team has been working with international amyloid experts on
the development of therapeutic cures to amyloid-related diseases, including Alzheimer's Disease, Secondary Amyloidosis,
Diabetes Type II and Hemorrhagic Stroke due to Cerebral Amyloid Angiopathy. Neurochem has advanced three drug
candidates to clinical trials for Alzheimer's Disease, Secondary Amyloidosis and Hemorrhagic Stroke.
At present, the Company employs over 60 people and is located in Saint-Laurent, Canada (www.neurochem.com).
All of the statements contained in this news release, other than statements of fact which are independently verifiable at the
date hereof, are forward-looking statements. Such statements, based as they are on the current expectations of management,
inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of
general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the
jurisdictions in which Neurochem does business, stock market volatility, fluctuations in costs, and changes to the competitive
environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated
results expressed in the forward-looking statements.
For further information
Dr. Lise Hébert, Director, Communications and Investor Relations, Neurochem Inc., (514) 337-4646,
lhebert@neurochem.com, www.neurochem.com
M. Hans Henrik Munch-Jensen, Senior Vice President, H. Lundbeck A/S, 45 36 30 15 11 poste 2660,
hhmj@lundbeck.com, www.lundbeck.com
Mike Polonski, Investor Relations, The Equicom Group Inc., (416) 815-0700 ext. 231,
mpolonski@equicomgroup.com, www.inverstorlook.com |
