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New Clinical
Study Shows CLA Reduces Body Fat
Study published recently in The Journal
of Nutrition concludes that the natural dietary supplement
conjugated linoleic acid (CLA) reduces body tat in people
who are overweight or obese.
The study is the largest published scientific
evidence to date showing that the natural supplement reduces
the weight of fatty tissue in humans. The double-blind, randomized,
placebo controlled study confirms a series of previous
animal and human studies, which concluded that CLA improves
body composition by reducing fat and preserving muscle tissue.
"We found an average reduction of six
pounds of body fat in the CLA group compared to placebo,"
said project manager Ola Gudmundsen, chief executive officer,
Scandi navian Clinical Research a/s, Kjeller, Norway. "This
new scientific evidence supports previous observations that
CLA is quite effective as a fat-fighting supplement."
In the study, sixty overweight people
were randomly assigned to take a placebo or CLA for twelve
weeks. The main objectives of the study were to investigate
the effects of different doses of CLA given from 1.7 grams
to 6.8 grams per day, compared to placebo.
Results showed measurable improvement
in the body's fat mass. All study participants were given
the option to undertake light exercise and moderate their
food intake. The study indicates that 3.4 grams of CLA
per day is enough to obtain all the beneficial effects on
body fat. The group given the highest dose, 6.8 grams of CLA
per day, also experienced a light increase in lean body mass.
"CLA may be a valuable weight management
supplement to any diet regime. Keeping lean body mass and
speeding up fat loss are the keys to a successful weight loss
program," said study co-author Jan Wadstein, associate professor
of medicine at Lund University in Sweden. "We are encouraged
by our findings and are involved in further research on CLA's
ability to expedite fat loss and preserve muscle mass."
CLA is widely available in Europe and
the United States as an over-the-counter dietary supplement.
Two additional, independent studies on the body composition
effects of CLA are anticipated in
early 2001.
Autologous Cell-Based Gene Therapy from
UT
United therapeutics Corporation has formed
a new company with the inventor of a form of gene therapy
that does not have the toxicity issues of other forms of gene
therapy. This new kind of gene therapy inserts needed genes
into a person's cells after those cells have been extracted
from their body, and then injects the genetically modified
cells back into the person's body.
The approach avoids the need to use viral
vectors to bring new genes into the body, which gives rise
to toxic immunoreactivity and other health problems. The new
technology is called autologous cell-based gene therapy and
has been successfully proven in studies of animals with pulmonary
hypertension.
The inventor of the autologous gene therapy
approach to treating pulmonary hypertension and other diseases.
Dr. Duncan Stewart of the University of Toronto, agreed to
form a new Canada-based company with United Therapeutics,
and to license to that company the exclusive rights
to his invention.
The new company, called Endogen, is majority
owned by United Therapeutics with minority ownership
by Dr. Stewart's technology development company and by Dacha
Capital, a Montreal based investment fund. The new company
will also receive Canadian marketing rights to United Therapeutics'
second-generation prostacyclin analog, Unipeg. The CEO of
the new company will be Dr. Gilles Cloutier, who will also
continue to serve as United Therapeutics' executive vice president
for Business Development.
United Therapeutics is a biotechnology
company focused on combating cardiovascular, inflammatory
and infectious diseases with unique therapeutic products.
Trials on Sjogren's Syndrome Drug
Ends
A Marillo Biosciences Inc. (ABI) has announced
the completion of the company's second phase III clinical
trial in primary Sjogren's syndrome. Sjogren's syndrome is
an autoimmune connective tissue disorder, which
affects between 1 and 2 million people in the United States
and a similar number in Europe.
Sjogren's syndrome patients characteristically
suffer from dry mouth and eyes. Dry mouth frequently compromises
the oral health of these patients and makes it difficult to
eat and talk. Increasing natural saliva production is a treatment
goal in Sjogren's syndrome patients.
The phase III clinical trial was a double-blinded,
placebo-controlled study in which 256 patients were treated
three times daily with a lozenge containing either 150 International
Units of natural interferon alpha (IFN-a) or with
a placebo for 24 weeks. An improvement in saliva production
was noted in the group given IFN-a. This result was similar
to that seen in the initial phase III study, which utilized
the same protocol. The most robust increases were noted in
unstimulated whole saliva (UWS) production, with the IFN-a
treated patients who completed the entire 24 weeks demonstrating
more than 2 times the increase of the placebo group. Increases
in stimulated whole saliva (SWS) and improvement in a number
of subjective measures of dry mouth also favored the IFN-a
group.
The company plans to discuss these findings,
in addition to the combined results of the phase III clinical
studies, with the PDA during an upcoming teleconference. When
results from the two identical phase III trials are combined,
significant increases in UWS are found at the 24 week time
point in the IFN-a treated patients corn pared to controls
(p=0.0134). Moreover increases from baseline in UWS within
the IFN-a group were highly significant (p=0.0005).
Patients within the IFN-a treated group
also had significant (p=0.0001) improvement from baseline
in symptoms of oral dryness, oral comfort and throat dryness.
"The finding of an increase in UWS is particularly
important for patients with Sjogren's syndrome, as UWS represents
the baseline production of saliva that patients experience
throughout the day," said Joseph M. Cummins, president.
Experimental
Diabetes Drug Shows Promise
An experimental drug for for type 2 diabetes
shows promise in patients with mild forms of the disease,
researchers of the drug company Insmed Inc said.
In type 2 diabetes, cells stop responding
to insulin, a molecule that regulates the levels of sugar
in the blood. The new drug, called INS-1, helps cells respond
to insulin by replacing a molecule essential for the process.
In a study of 165 patients, measurements
of blood sugar stability rose significantly in those who took
INS-1 for 3 months together with drugs that stimulate the
body's production of insulin. The results were more pronounced
in patients with less severe diabetes, according to a statement
from the drug's developer, Richmond, Virginia based
Insmed Incorporated.
Patients taking an inactive placebo instead
of INS-1 did not show an increase.
"The results suggest that INS 1 may be
a more effective therapy in patients with less severe type
2 diabetes," Insmed CEO Dr. Geoffrey Allan said during a telephone
press conference Friday. The drug also appeared to improve
cholesterol levels, Allan noted.
Side effects of INS-1 included aches and
pains, headaches, nausea, and muscle cramps, "but were indistinguishable
compared to those of the placebo," Allan said.
"Clearly, we are very pleased with the
outcome of this clinical study," said Allan, who said he hopes
the drug will be available to consumers by the year 2004.
Shares of Insmed had fallen in late November last year after
preliminary results of a study of INS-2 showed no significant
difference between the effect of the drug versus placebo.
Ethypharm Obtains
US Patent for Encapsulation Technology Using SCFs
Ethypharm group announced that its subsidiary
Mainelab has been granted US Patent 6,087,003 for its solvent-free
encapsulation technology based on the use of super critical
fluids (SCF).
This innovative drug delivery technology
is especially useful for the preparation of injectable microparticulate,
sustained-release formulations of proteins.
The proprietary Super Critical Fluid process
of Ethypharm has substantial promise due to its unique combination
of advantages compared to classical microencapsulation techniques
and other SCF-based processes. Since it is a totally
solvent-free technology and processed at low temperature without
an aqueous phase it is ideally suited for microencapsulation
of fragile molecules such as recombinant proteins and peptides
(e.g. EPO, Interferon).
Proteins and peptides in their lyophilised
form can be encapsulated in lipid or biodegradable polymer
microparticles, and are therefore suitable for sustained release
formulations destined for parenteral
administration.
Ethypharm-Mainelab has already been granted
the corresponding European Patent and has 4 families of patent
on Super Critical Fluid-based encapsulation technologies.
Several pre-clinical programs are currently underway for injectable
sustained-release formulations of recombinant proteins.
Results obtained on date are most promising, demonstrating
high stability of the encapsulated proteins and long lasting
in vitro release profiles.
Ethypharm is a privately owned pharmaceutical
company founded in 1977, specialising in drug delivery systems
for both oral and injectable routes of administration. Ethypharm
owns several proprietary technologies organised around 4 technology
platforms: oral modified release, taste masked and orodispersible
formulations enhanced absorption and injectable sustained
release formulations. This new proprietary technology completes
the Ethypharm offer to the pharmaceutical industry to develop
new unique and exclusive drug formulation.
RPI's Announces
New Product Candidate for Chronic Hepatitis B
Ribozyme Pharmaceuticals Inc (RPI) announced
the selection of its product candidate targeting the Hepatitis
B Virus (HBV), HepBzyme. This ribozyme targets several HBV
RNA transcripts as well as HBV pregenomic RNA. The candidate
represents a completely new approach to treating HBV, differing
significantly from existing therapies. HepBzyme is RPI's fourth
product candidate, the first three being Angiozyme, Heptazyme,
and Herzyme. RPI intends to file an IND and complete a Phase
I clinical trial for HepBzyme in 2001.
HepBzyme was selected based in part on
antiviral activity screening in cell culture where it was
found to inhibit viral replication at several stages of the
HBV life cycle. Furthermore, HepBzyme was found to decrease
serum HBV DNA levels in a HBV transgenic mouse model by statistically
significant levels as compared to controls.
Hepatitis B virus is one of the most widely
spread viral infections. It is currently estimated that there
are over 300 million chronically infected patients world wide,
with 1.25 million in the U.S. alone.
"HepBzyme represents a novel approach
to the treatment of chronic Hepatitis B. The early clinical
studies of the molecule should provide insight into the potential
of this exciting compound", said Dr. Willis Maddrey, Executive
Vice President for Clinical Affairs at the University of Texas,
Dallas.
"HepBzyme represents a significant new
market opportunity for RPI and adds a second important drug,
along with Heptazyme for treatment of chronic Hepatitis C,
to our antiviral portfolio," said Ralph E. Christoffersen,
CEO
Intellipharm PK
Intellipharm PK is a software program
developed for Windows that simulates drug plasma concentrations
based on drug physical and pharmacokinetic pharmeters.
All output is in the form of text files that can be easily
graphed using Microsoft Excel.
The software provides guidance in selecting
drugs that will have a better chance of surviving development
hurdles. Through simulation, selection criteria for drug properties
can be established. When improvement in drug properties
is needed, the magnitude of improvement can be gauged to decide
whether to use synthetic or formulation modification.
For details,
contact:
Intellipharm, LLC,
P O Box 644,
Niantic, CT 06357-0644
Tel : 860 691 0142
Fax : 860 739 4261
Integrated NMR Chemical Analyzer
The Integrated NMR Chemical Analyzer is
designed for use by non-NMR-spectroscopists who need the analytical
power of a modern FT-NMR, but do not have the facility for
a traditional NMR spectroscopy lab. The new INCA is ideal
for dedicated applications such as on-line process control,
ZC/QA analyses, clinical diagnostics, and chemical screening.
The INCA combines Ultra Shield super-conducting
magnets with the superior AVANCETM console and a Windows NT
computer in a single, rugged, portable transport enclosure.
For details,
contact:
Bruker Instruments Inc. (NMR),
19 Fortune Dr., Manning Park,
Billerica, MA 01821
Tel : 978 667 9580
Fax : 978 667 0985
Capsule Machines
The Bohanan 2000 Plus, hard gelatin encapsulation
machine designed to fill capsules at a rate of 2000 plus capsules
per minute. The 2000 plus capsule machine measures 66
inches tall, 47 inches wide and 47 inches deep. The
2000 plus capsule machine is the latest in the advanced technology
of manufacturing that the A.W. Bohanan company produces for
the Pharmaceutical and Herbal industry. The 2000 plus
capsule machine is the perfect answer for all your capsule
filling needs from those hard to fill herbal products to any
pharmaceutical product on the market today the Bohanan 2000
plus can handle the workload. Put the 2000 plus capsule
machine to the test and see why some of the country's largest
company's are turning to Bohanan products to fill all there
capsule needs.1
For details, contact:
A.W. Bohanan Company (AWB),
2006 Dallas-Cherryville Hwy
279, Dallas, NC 28034
Tel : 704-922-9811
Fax : 704-922-5658
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