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Innovative Israeli drug for treating prostate cancer approved in Mexico

A successful Phase III clinical trial in Latin America, involving 80 patients, confirmed the high rate of local cures and minimal side effects, as evidenced by negative biopsies and maintenance of patients’ potency, continence and quality of life.


A therapy invented at the Weizmann Institute of Science and clinically developed in collaboration with Steba Biotech (Luxembourg) has been approved by Cofepris, Mexico’s health authority, for the focal treatment of early-stage prostate cancer.

The therapy involves a laser and a novel drug, TOOKAD® Soluble. A successful Phase III clinical trial in Latin America (Mexico, Peru and Panama), involving 80 patients, confirmed the high rate of local cures and minimal side effects already reported in Phase II clinical trials, as evidenced by negative biopsies and maintenance of patients’ potency, continence and overall quality of life.

The marketing approval in Mexico comes in the wake of the recent completion of a second Phase III clinical trial in Europe. This randomized pivot study compared disease progression, cancer-free rate and urinary and erectile functions in patients treated with TOOKAD® Soluble and those undergoing active surveillance with a follow-up of two years. It involved more than 400 patients at 43 hospitals in 11 European countries and is currently under evaluation by the European Medicines Agency (EMA).

The approved therapy follows a new paradigm developed by Prof. Yoram Salomon of the Biological Regulation Department and Prof. Avigdor Scherz of the Plant and Environmental Sciences Department in the framework of photodynamic therapy. It comprises an intravenous infusion of TOOKAD® Soluble, immediately followed by near-infrared laser illumination through thin optic fibers that are inserted into the cancer prostatic tissue, under ultrasound control. Tookad® Soluble was first synthesized in Scherz’s lab from bacteriochlorophyll, the photosynthetic pigment of certain aquatic bacteria that draw their energy supply from sunlight. The drug stays in the patient’s blood circulation until it totally clears 3-4 hours later, and it shows no toxicity. Confined illumination of the diseased tissue activates the circulating drug locally, resulting in the extensive generation of short-lived toxic molecules: oxygen and nitric oxide radicals. These highly reactive molecules initiate rapid occlusion and destruction of the tumor
blood vessels, followed by necrotic death of the entire tumor while sparing nearby structures and their functions. The use of near-infrared illumination, together with the rapid clearance of the drug from the body and the unique non-thermal mechanism of action, makes it possible to safely treat large, deeply embedded cancerous tissue using a minimally invasive procedure. The recent marketing approval was provided to both the drug (TOOKAD® Soluble) and the laser illumination device (Laser), together designated Vascular Targeted Photodynamic Therapy (VTP) with TOOKAD® Soluble.

In the currently approved focal therapy setting, TOOKAD® Soluble VTP (TS-VTP) is a day-case procedure lasting approximately 90 minutes. Patients are released a few hours later and can return to normal activities within a few days, with none of the side effects frequently associated with prostate removal by surgery or radiotherapy. This new minimally invasive technology offers a good alternative to patients diagnosed with early-stage prostate cancer. The number of these patients has dramatically increased in the last two decades due to widespread screening relying on levels of prostate specific antigen (PSA). This population faces the dilemma of undergoing the radical treatment of prostate removal with the risk of high morbidity, or remaining under active surveillance with increased risk of further cancer progression.

Tookad® Soluble answers an unmet need in providing this category of patients with an appropriate treatment, which combines good efficacy with a preservation of the quality of life.

Weizmann institute and Steba Biotech are currently pursuing an extensive oncological research program in collaboration with several clinical groups at Memorial Sloan Kettering Cancer Center in New York City. Four clinical studies for more advanced prostate cancer and other oncological indications stemming from this research are scheduled to start in 2016.

Yeda Research and Development Company, the Weizmann Institute’s technology transfer arm, has licensed the drug to Steba Biotech, which manufactures Tookad Soluble. Amir Naiberg, CEO of Yeda: “Our cooperation with Steba covers 20 years of fruitful collaboration. The commitment made by the shareholders of Steba and their personal relationship and effective collaboration with Weizmann Institute scientists and Yeda, have enabled this tremendous accomplishment.”
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US Approves 1st New Lupus Drug in 50 Years

  • Published in Health

 

Lupus Drug - First medication ever developed specifically for the autoimmune disorder

 

Vidushi Sinha, Washington, D.C.
VOA NewS
The first new drug to treat lupus in a half century - and the first ever specifically developed to treat the autoimmune disorder - is heading to market in the United States. Under the trade name Benlysta, it is the first federally-approved drug to be derived from genomics, the study of genes and their functions.
Eva Gaskin has been married for 17 years. But one day four years ago, she suddenly was unable to recognize her husband, and became convinced that he had killed her family. Doctors said these strange mental episodes were symptoms of lupus cerebritis, which caused inflammation in her brain tissues.
"I had anxiety. I had insomnia," says Gaskin. "I had lots of things going on that we really did not understand and that was very frightening for my family until I got on the proper treatment, and those kinds of issues started to subside. But at first it was very scary.”
The brain inflammation that made Eva see her husband as a stranger and a killer soon moved to her lungs, and her breathing became painful. Lupus is a potentially fatal disease. It develops when the body's protector cells stop differentiating between healthy cells and bacteria. As a result, the immune system starts attacking its own body instead of protecting it from bacteria, viruses and parasites.
Until now, lupus sufferers have treated their varied symptoms - from mental disorders to skin rashes and painful joints - with a combination of drugs, including painkillers, steroids and anti-malarial medicines. Aside from being insufficient, these treatments have also carried the risk of toxicity.
But now, for the first time in 50 years, the U.S. Food and Drug Adminsitration has approved a new drug specifically to treat lupus.
“It’s so exciting to see that a drug is coming out that targeted specifically for lupus patients because in the past we have been taking drugs that have been found helpful but not specifically for us,” says Gaskin.
Benlysta also represents a medical milestone. Its American developer, Human Genome Sciences, calls it the first drug derived from the genetic mapping of human proteins.
Company vice-president Barry Labinger says the firm is proud of the fact that after so many years of research, development, and clinical trials, they finally have an anti-lupus drug that directly targets the autoimmune disorder.
“Benlysta works on the immune system by blocking a part of the immune system that becomes over-active in the presence of autoimmune disease," says Labinger. "Autoimmnue disease in particular tends to happen far more frequently in women and people of color and so Benlysta turns out to be an important drug for those patients, as well as a broader population for anybody who has lupus.”
Lupus affects women nine times more than it does men. And it occurs disproportionately in African-American, Hispanic and Asian populations.
Labinger says Benlysta is not a miracle drug, and it's not for everyone. “It is a very important step forward. There is room for more than one treatment for lupus patients over time and we hope that this is a first step towards a number of advances for patients with lupus.”
Human Genome Sciences will soon begin a large study of African-American lupus patients.
In the meantime, lupus sufferer Eva Gaskin says her condition is stable for now, but she's relieved she has Benlysta to fall back on if her lupus should flare up again.

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