Cystic Fibrosis Axentis Pharma Initiates Clinical Trial For Lung Infections

Axentis Pharma AG has initiated a clinical phase IIa trial to assess the safety and tolerability of a new therapeutic formulation for the treatment of severe pulmonary infection in cystic fibrosis patients. The new formulation allows an established therapeutic agent to be delivered directly to the site of infection. The forthcoming trial will also compare the effects of two different doses of the new drug. Initial results are expected in summer 2009. Axentis Pharma acquired all the necessary rights for this formulation from international partners just eight months ago. In addition to these advances, the company has also succeeded in appointing two renowned experts to its Scientific Advisory Board.

Axentis Pharma AG (Switzerland) announced today that all the necessary requirements for a clinical phase IIa trial have been fulfilled. The objective of this trial is to assess the safety and tolerability of an inhalable tobramycin, a well characterised and established drug for the treatment of pulmonary infection in cystic fibrosis patients. The product ARB-CF0223 also known as Fluidosome(R) tobramycin is a liposomal formulation of tobramycin, delivered directly to the site of infection via standard nebulizers. ARB-CF0223 has an improved safety profile and higher efficacy compared to current treatments for infections of the respiratory tract in patients with cystic fibrosis. It can be used in lower doses and also reduces the frequency and severity of side effects for pulmonary infections. The company expects to begin recruiting patients at its four international trial centres by the end of the year.

Dr. Hans Schreier, Chief Scientist of Axentis Pharma on the advances the company has made: "It was only very recently that we obtained all the necessary legal rights including transfer of sponsorship of the EMEA Orphan Designation to further develop our current lead product, Fluidosome(R) tobramycin. However, we are already in a position to initiate clinical trials to fully assess its safety and tolerability and gather information on appropriate doses. I am very pleased for patients suffering from cystic fibrosis, who will benefit directly from this promising once-a-day treatment: a significant improvement both in treatment and patient management. This is also great news for our investors, who have helped us to advance so far in a very short time."

Fluidosome(R) technology is based on the well characterised drug tobramycin. Utilising synthetic liposomes containing tobramycin, a standard nebulizer delivers the drug directly to the endobronchial sites of infection in cystic fibrosis patients. This results in prolonged, high local drug concentration, which in turn achieves higher efficacy and enables lower doses.

The phase II study will be carried out in 4 international centres. A total of 24 patients will receive treatment: Eight will receive a twice-daily 300 mg dose of the current tobramycin formulation over 28 days; another eight will be given a twice-daily 150 mg dose of Fluidosome(R) over two weeks and later a third group will receive one 300 mg dose of Fluidosome(R) per day for two weeks.

The company has also announced the appointment of two renowned experts to its Scientific Advisory Board. Prof. Adriano Aguzzi, Director of the Institute of Neuropathology at University Hospital Zurich, Switzerland and Prof. Gergely C. Lukacs, Canada Research Chair, Department of Physiology at McGill University Montreal, Canada will in future advise Axentis Pharma on scientific and medical issues related to the company's product pipeline.

Dr. Schreier on the latest additions to the team: "Axentis Pharma is very happy to have such outstanding experts on its Scientific Advisory Board. Just as our investors provide us with the trust and financial means that are essential to the ongoing development of our products, Prof. Aguzzi and Prof. Lukacs will contribute to the intellectual capital of Axentis Pharma."

About cystic fibrosis

Cystic fibrosis is the most common life-threatening hereditary disease amongst Caucasian populations. The disease is caused by a mutation in the CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) gene found on chromosome 7. This mutation causes increased secretion deposits on mucous membranes. Lung complications represent the most serious manifestation of the disease ­ and the reason for the high mortality rate amongst patients. Such complications often involve infection of the bronchi by the bacteria Pseudomonas aeruginosa. Chronic inflammations then cause lung functions to become blocked. Besides the break-down of lung tissue, this also leads to bronchiectasis and lung failure.

About Axentis Pharma AG

Axentis Pharma AG is a Swiss biotechnology company. The company is using a patent-pending platform technology to develop therapies for diseases caused by incorrect protein folding in the endoplasmic reticulum. The most prominent example of such diseases is cystic fibrosis (mucoviscidosis).

About Fluidosome(R) technology

Axentis Pharma's Fluidosome(R) technology uses biocompatible lipids endogenous to the lung that are formulated into small liposomes. This nanocapsules platform opens broad applicability for unmet medical needs including other respiratory diseases. In the case of the Fluidosome tobramycin(R), the interaction between tobramycin and the microbial cell is triggered when the liposomes attach to the outer cell membrane. Tobramycin then leaches into the inner cell compartment, which leads to rapid cell death.

Nature Inspires New Highly Specific Drugs And Organic Products

The best place to seek novel compounds for pharmaceutical drugs, alternative energy sources, and a host of industrial applications, is within natural systems that have evolved over millions of years. Scientists now realise that the precise molecular arrangements within natural pathways in organisms have been highly tuned for specific processes and provide both compounds that can be exploited directly and vital information over how to synthesise new products by mimicking biochemical processes. The bright future for research and development around such natural products was discussed recently at a conference organised by the European Science Foundaton (ESF), and the European Cooperation in the field of Scientific and Technical Research (COST).

"We found that natural products provide invaluable leads for drug discovery and opportunities to explore chemical and biological pathways, both of which are essential to advancing the life sciences," said the conference chair K.C. Nicolaou from the Scripps Research Institute in the US. Some of the products discussed at the conference were ready for preclinical development, having shown great potential for treating a range of infectious and metabolic diseases as well as cancers.

Such products are creating excitement because they promise to combine more effective treatment with reduced side effects, as well exploiting clean non-toxic synthetic techniques. For example Maurizio Botta from the University of Sienna in Italy discussed the design, synthesis and biological evaluation of new compounds for tackling AIDS and HIV by inhibiting reverse transcriptase, the process by which this type of retrovirus virus hijacks the host cell's genetic machinery to replicate itself. Some of these compounds have already exhibited strong activity against the AIDS virus in the laboratory.

There were also a number of promising anti-bacterial agents presented at the conference, which is an important development given the growing resistance of some bacterial species to existing antibiotics and the growing problem posed by MRSA, the "super bug" that plagues many hospitals and nursing homes. Dionisios Vourloumis, research director at the state run Greek research centre NCSR Demokritos, explained how bacteria could be disabled by targeting the RNA binding molecules needed for their genes to be expressed.

It is important to distinguish between the highly specific compounds being developed by researchers in natural products, and existing herbal remedies that often have dubious therapeutic value. "The difference from herbal medicine is that chemists are talking about pure active ingredients, precisely defined at the molecular level, as opposed to crude, multi-component mixtures of compounds contained in herbal medicines," said Nicolaou.

Although, as Nicolaou emphasised, the main focus of the natural products field is on drug discovery and exploitation of biological pathways to treat disease, the synthetic processes involved also have great potential for developing novel products for a variety of industrial applications, particularly in the chemical industry. One active area of research lies in harnessing the reaction centres of photosynthesis to produce clean sustainable energy converted from the sun without using fossil fuels, just as plants do. This could either be done by engineering new types of plant or photosynthesising cyanobacteria, or mimicking these processes to synthesise artificial systems that perhaps are more convenient to deploy.

The synthetic strategies developed to synthesize natural products also have great potential for green chemistry, involving manufacture of compounds for different applications using sustainable techniques that reduce or eliminate toxic by-products, for example in the paper manufacturing industry. The overall focus was in harnessing the tools of chemistry to develop new techniques for synthesising organic compounds for a variety of purposes, with improved efficiency and sustainability.

The ESF-COST conference on Natural Products Chemistry, Biology and Medicine was held near Naples in Italy in May 2008.

Third Clinical Trial Shows Pine Bark Naturally Reduces Knee Osteoarthritis

According to the Center for Disease Control (CDC), osteoarthritis, the most common type of arthritis, is on the rise. A new study published in the August journal of Phytotherapy Research, reveals Pycnogenol, bark extract from the French maritime pine tree, reduced overall knee osteoarthritis (OA) symptoms by 20.9 percent and lowered pain by 40.3 percent. To date, this is the third clinical trial on osteoarthritis treatment with Pycnogenol. This study investigated what happens to joint symptoms after treatment with Pycnogenol is terminated and the results show that no relapse occurred after two weeks. Pycnogenol acts as potent anti-inflammatory and the lasting effects found in this study suggest that Pycnogenol may help the joints to recover.

With osteoarthritis cases on the rise, many are seeking non-traditional medication to help ease the pain and reduce the amount of traditional medication taken. The CDC estimates osteoarthritis affects 34 percent of all adults over the age of 65. In 2005, an estimated 26.9 million adults in the U.S. had osteoarthritis, which was up from 21 million in 1990. While there's no known cure for osteoarthritis, treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics can help reduce pain and also maintain joint movement, to help the quality of life for people living with the disease. In more severe cases, cortisone shots and joint replacement surgery are used to treat OA.

"The current study is in accordance with the two previous Pycnogenol studies for osteoarthritis," said Dr. Peter Rohdewald, one of the researchers of the study. "Again the pain is gradually decreasing during the course of three months treatment with Pycnogenol. An improvement is found after the first month and a further improvement is seen after two months, where values are significantly different to the placebo group. This study again showed that patients required significantly less analgesic medication while supplementing with Pycnogenol, whereas this was not the case with the placebo-treated control group."

The study was held at Slovakia's Comenius University School of Medicine. One hundred patients with stage I or II OA were included in the study and were randomly allocated to either a Pycnogenol or placebo group. Patients were supplemented with 150 mg Pycnogenol or placebo per day over a period of three months. They were allowed to continue taking their NSAID or analgesics prescribed before the study but had to record every pill taken. The established Western Ontario McMaster questionnaire for joint function was employed to rate the pain level, and obtain measures of joint stiffness and to what extent the arthritis affects participation in daily activities. Patients were investigated in two week intervals over the treatment period of three months and a final time two weeks after discontinuation of medication.

The overall score, summarizing pain, stiffness and daily activities, improved statistical significantly by 20.9 percent in the Pycnogenol group. Interestingly, the joint improvement achieved with Pycnogenol persisted after intake of Pycnogenol was discontinued for four weeks. The joint pain decreased by 40.3 percent after completion of the three months supplementation with Pycnogenol and two weeks later the pain was still 36.1 percent lower than at baseline. Furthermore, 38 percent of patients in the Pycnogenol group required less NSAID's or other analgesic medication for joint pain.

"The anti-inflammatory potency of Pycnogenol explains the success in lowering joint pain and stiffness for arthritic joints," said Rohdewald. "After three recent clinical studies on osteoarthritis, Pycnogenol continues to demonstrate its effectiveness for osteoarthritis symptoms making it a viable, natural and safe alternative for individuals. This is the first study that investigated whether a relapse of symptoms occurs after taking Pycnogenol is stopped. The results show a lasting effect after discontinuation which suggest the anti-inflammatory mechanisms of Pycnogenol has allowed the joints to recover."

In another study this year (also published in the journal of Phytotherapy Research), Pycnogenol was shown to reduce osteoarthritis symptoms by 56 percent. Moreover, patients required 58 percent less standard pain medication, which greatly improved the gastrointestinal complications resulting from the pain medication by 63 percent. Last year, a study on osteoarthritis carried out at the University of Arizona Tucson (published in Nutrition Research) discovered that Pycnogenol was effective for improving pain and joint function. After three months in the Pycnogenol group, there was a reduction of 43 percent in pain, 35 percent in stiffness and 52 percent in physical function subscales, respectively. The placebo group showed no significant scores throughout the entire study.

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Article adapted by Medical News Today from original press release.
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Horphag Research, the exclusive worldwide distributor of Pycnogenol has filed for several patents for Pycnogenol's application for COX-1 and COX-2 inhibition and treatment of osteoarthritis.

About Pycnogenol®

Pycnogenol® is a natural plant extract originating from the bark of the maritime pine that grows along the coast of southwest France and is found to contain a unique combination of procyanidins, bioflavonoids and organic acids, which offer extensive natural health benefits. The extract has been widely studied for the past 35 years and has more than 220 published studies and review articles ensuring safety and efficacy as an ingredient. Today, Pycnogenol® is available in more than 600 dietary supplements, multi-vitamins and health products worldwide. For more information, visit http://www.pycnogenol.com/.

Natural Health Science Inc. (NHS), based in Hoboken, New Jersey, is the North American distributor for Pycnogenol® (pic-noj-en-all) brand French maritime pine bark extract on behalf of Horphag Research. Pycnogenol® is a registered trademark of Horphag Research Ltd., Guernsey, and its applications are protected by U.S. patents #5,720,956 / #6,372,266 and other international patents. NHS has the exclusive rights to market and sell Pycnogenol® in North America and benefits from more than 35 years of scientific research assuring the safety and efficacy of Pycnogenol® as a dietary supplement. For more information about Pycnogenol® visit our Web site at http://www.pycnogenol.com/.

A Cup of Green Tea Per Day May Help Keep Skin Cancer Away

Thursday, October 12, 2006 by: NewsTarget
Skin cancer is the most common form of cancer in the United States, and it is estimated that more than 1 million cases of basal and squamous cell cancer will be diagnosed this year according to the Centers for Disease Control.

While avoiding prolonged sun exposure, the regular and proper use of sunscreen, and regular examinations by a board-certified dermatologist are the main actions for preventing skin cancer, green tea may help as well.

"Green tea is reported to have antibacterial, antioxidant, and antitumor properties," says Lawrence Osman, M.D., a board-certified dermatologist practicing in Los Angeles. Polyphenolic antioxidants are derived from the extracts of green tea . Also, the most widely studied component of green tea, (-)-epigallocatechin gallate, may work by inhibiting ultraviolet induced DNA damage. Inhibiting ultraviolet induced DNA damage may be important because many cases of skin cancer are directly related to ultraviolet exposure from the sun or tanning beds.

The constituents of green tea have already proven effective in helping to prevent skin cancer in the lab. Accordingly, drinking green tea, in addition to avoiding prolonged sun exposure, the regular and proper use of sunscreen, and regular examinations by a board-certified dermatologist, may help prevent skin cancer in life.

About Lawrence Osman, M.D., F.A.A.D. Dr. Lawrence Osman is a board-certified dermatologist practicing comprehensive medical, surgical, and cosmetic dermatology. He attended the Keck/USC School of Medicine and completed his dermatology training at the prestigious Roswell Park Cancer Institute. He has particular expertise in skin cancer surgery, laser surgery, and tumescent liposuction. He was voted as one of the best dermatologists by the readers of the Los Angeles Daily News.

Hospitals using alternative treatments in tandem with traditional approaches

Originally published April 28 2005 at NewsTarget.com
Hospitals across the United States are increasingly using a number of alternative treatment techniques in tandem with their more traditional approaches. The American Hospital Association says about 17 percent of hospitals now offer some sort of alternative treatment such as reiki or massage therapy to complement their traditional physical therapy services. That's up from 8 percent in 1998.

* Psychiatrist Dr. Eric Leskowitz and physical therapist Tamara Geist treat Paul Spada for chronic pain with reiki at Spaulding Rehabilitation Hospital in Boston.
* is one of a number of nontraditional healing practices making inroads into hospitals nationwide.
* According to the American Hospital Association's latest available survey of hospitals, 17 percent of hospitals offered complementary or alternative medicine services in 2002, up from 8 percent in 1998.Along with reiki, other therapies available in local hospitals include therapeutic touch , aromatherapy, massage, energy healing and reflexology.
* Integrative medicine sticks to much of the protocol of conventional medicine, but ties in a holistic approach that incorporates treating the whole person since emotions and attitudes are intimately linked to disease and recovery.Registered nurse Dorene Kominsky of Easton learned this first-hand.
* She introduced complementary therapies by becoming a member of the Pain Control Committee and went on to train 66 nurses in energy healing and reiki .
* Eric D. Leskowitz, director of Spaulding's Integrative Medicine Task Force, is working on a pilot study to measure the impact of energy work on chronic pain and to show that energy work is beneficial beyond the standard approach.''The main idea is to compare those patients who get the standard rehab program with those who get the standard plus twice weekly energy work,'' Leskowitz said.Staff nurse Maureen P. Foye, working with Leskowitz on the study, has spent the past 10 of her 20-year nursing career at Spaulding's Inpatient Chronic Pain Unit incorporating therapeutic touch and energy healing into her treatment of patients while Tamara A. Geist, a physical therapist, provides reiki treatment.''Many patients report decreased anxiety and pain and a deep feeling of peace after a treatment,'' said Foye, who uses therapeutic touch to smooth and balance the energy field which she says can promote healing.'The human energy field extends beyond the body and can become imbalanced, which then affects the physical body,'' Foye said.