University of Michigan Data Presented at ICAAC Conference Shows Emulsion Kills
Virus
SAN DIEGO, Sept. 26 /PRNewswire/ -- Novavax, Inc. (Amex: NOX), announced
today that BCTP, an antimicrobial "nanoemulsion," is showing promise in
killing influenza A virus, the most common form of flu virus. The data from
two separate preclinical studies were presented by University of Michigan (U-
M) researchers at the annual Interscience Conference on Antimicrobial Agents
and Chemotherapy (ICAAC) in San Diego. The U-M research associates, Andrzej
Myc and John D. Reuter, issued their findings to colleagues in a poster
presentation at the ICAAC conference, considered one of the country's top
gatherings on infectious disease.
BCTP is an emulsion or "nanoemulsion" developed at the Novavax
laboratories in Rockville, Maryland, by D. Craig Wright, M.D., chief
scientific officer at Novavax, Inc. Laboratory studies conducted by Novavax
indicate that BCTP may inactivate most if not all enveloped viruses that cause
human disease, as well as spores, bacteria and sperm.
According to the first study, BCTP reduced viral antigen levels by
99.6 percent in Madin Darby Canine Kidney (MDCK) cells incubated with the
influenza A virus. MDCK cells are commonly used by researchers to evaluate
the toxic effects of viruses. Along with the virus, the MDCK cells were
treated with five different lipid emulsions developed by Novavax, including
BCTP. Using two different assay techniques, the number of cells infected with
the virus were then measured. While all five formulations slowed the spread
of the virus, BCTP was the most potent.
In the second in vivo study, different liquids were inserted into the
nasal passages of four groups of laboratory mice. Control mice in Group 1 were
given ordinary saltwater. Group 2 received BCTP alone, Group 3 received
influenza A virus and Group 4 was given a mixture of influenza A and BCTP.
Mice receiving influenza A and BCTP stayed healthy, while all the mice who
received the virus only developed severe pneumonia and two out of the three
mice died before the conclusion of the study.
"These are preliminary, small-scale studies, but the results indicate this
material, called BCTP, shows promise as a new weapon against the influenza A
virus," said James R. Baker, Jr. M.D., professor of internal medicine and
director of the Center for Biologic Nanotechnology in the U-M Medical School.
"Its main advantages are its rapid killing action, lack of specificity, and
the fact that it is non-toxic to skin and mucous membranes."
"We learned several important things from these preliminary studies. The
first is that BCTP is a highly effective killing agent for the influenza virus
both at the cellular level and in living animals. Equally important is that
BCTP had no toxic effects on nasal or lung membranes," continued Dr. Baker.
"We've shown that if we treat the virus with BCTP as it enters the nasal
passages, we can prevent infection in mice. The next step is to see whether
we can administer BCTP and the virus separately and still prevent infection.
And the final step, of course, is to see whether it works as well in people as
it does in mice."
"We believe the emulsion acts on the enveloped virus by first fusing or
merging with the lipid envelope of the virus, opening gaps," said Dr. Wright.
"Then the solvent, carried by the lipid structures, destroys the inner
membrane of the virus. Finally the detergent, also carried by the lipid
structures, degrades the inner contents of the virus."
Influenza affects approximately 10-20% of the U.S. population every year,
resulting in 20-50 million cases annually. Approximately 20,000 Americans die
as a result of influenza each year. While influenza vaccines are relatively
effective at preventing the flu, there is a need for additional therapies.
BCTP was developed using Novavax's proprietary emulsion technology. The
technology is currently being tested for additional applications, such as the
inactivation of anthrax spores and sperm. In collaboration with the National
Institute of Health, spermicidal testing of several of Novavax's emulsions
will begin either late 1998 or early 1999.
Novavax, Inc. is a biopharmaceutical drug delivery company headquartered
in Columbia, Maryland. The Company currently has two product candidates in
human clinical testing. Novavax's two lead topical drugs are: ESTRASORB(TM)
-- a patchless estrogen replacement cream and ANDROSORB(TM) -- a cosmetic-like
cream for testosterone replacement therapy in testosterone-deficient men.
Also in development is Helicore(TM) -- a non-antibiotic, anti-bacterial
product designed to eradicate H. pylori, the intestinal bacterium responsible
for most cases of peptic ulcer disease. "
In addition to historical information, statements made in this press
release that state the company's or management's intentions, hopes, beliefs,
expectations or predictions of the future are forward looking statements.
Forward looking statements may involve risks and uncertainties, including, but
not limited to, uncertainties related to the company's early stage of
development and clinical trials and marketability. These factors are more
fully discussed in the company annual report on form 10-K/A for the year ended
December 31, 1997.
For additional information please contact Novavax, Inc. or the University
of Michigan.
SOURCE Novavax, Inc.
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CONTACT: Brenda Fugagli, Chief Operating Officer and CFO of Novavax, Inc., 301-854-3900, ext 226; or Catherine Ferandin of Russell-Welsh, 650-312-0700, ext. 24, for Novavax, Inc.
NOTE TO EDITORS: An announcement on this subject is being released simultaneously by the University of Michigan.
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