New Clinical Study Shows CLA Reduces Body Fat

Introduction

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 further information please contact

A.W. Bohanan Company (AWB),
2006 Dallas-Cherryville Hwy
279, Dallas, NC 28034
Tel : 704-922-9811
Fax : 704-922-5658