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Posts Tagged ‘FDA’

Israeli Biotech Firm’s Diabetes Drug Passes FDA Phase 2 Trial

Thursday, January 30th, 2014

The U.S. Food and Drug Administration (FDA) has reported positive results in its Phase 2a trial of an oral insulin capsule produced by Israeli-based Oramed. The drug is for the treatment of Type 2 diabetes.

The Phase 2b study will be carried out later this year, and Oramed also plans a Phase 2a study for Type 1 diabetes.

Oramed’s stock jumped nearly 10 percent in NASDAQ trading in New York on Wednesday in after-hours trading following the announcement of the results of the trial.

“We are extremely pleased with the results, which give a solid validation for Oramed’s platform technology in general and our oral insulin program in particular,” said Nadav Kidron, Oramed’s chief executive.

Israeli Anti-Nausea Pill for Cancer Patients Passes Clinical Trial

Tuesday, April 24th, 2012

Israel’s RedHill Biopharma announced success last week in a major clinical trial of a new drug to prevent nausea in cancer patients.

The once-a-day pill RHB-102, which has now passed a trial corresponding to a Phase III clinical trial, will compete with leading anti-nausea drug Zofran, made by GlaxoSmithKline, which is taken several times a day.

Redhill will apply to the FDA for a pre-New Drug Application hearing for market approval in a few weeks.

Anti-nausea medications are estimated to be worth $2 billion around the world, according to a report in Globes online business news.

Immune System Holds ‘Key’ To Promising Haredi Biomedical Start-Up

Monday, December 29th, 2008

A small band of haredi biomedical pioneers, ensconced in the Lev Institute of the Jerusalem College of Technology, is on the verge of perfecting revolutionary peptide-based medicine that could cure a variety of life-threatening cancers and debilitating autoimmune diseases such as Crohn’s disease.

Dr. Yoram Devary and his partner, Professor Uziel Sandler, helm the fledgling Immune System Key biomedical start-up, where a handful of frum scientists earning about $1,000 a month are diligently working to perfect their peptide medicinal cure called Nerofe (a derivative of the Hebrew word for cure).

Both the Israeli government’s Chief Scientist’s Office and private investors have provided the initial funding for Immune System Key’s research and development. If Devary’s discovery successfully passes the clinical trial phase, which would spur the FDA to fast-track Nerofe’s development, Immune System Key’s corporate value would be expected to instantly skyrocket. Devary is convinced that Nerofe will benefit mankind.

 

 

Dr. Yoram Devary

 

Devary, who holds degrees in biology and chemistry from Hebrew University and studied at the University of California’s San Diego School of Medicine, became religious 27 years ago, when he met his future wife (who was already observant) on the campus of the Weizmann Institute of Science in Rehovot. Today, she works as an endocrinologist alongside her husband at Immune System Key.

“I’m a simple Jew trying to earn a parnassah by trying to help people. And I’m not interested in having people use the phrase “magic bullet” to describe our medical discovery. That’s an obscure expression. We know exactly how Nerofe works via a very simple and clear method,” Devary told The Jewish Press in an exclusive interview.

Nerofe was discovered after Devary’s wife prodded her husband to explore a genetic sequence found in the thymus (an organ in the chest cavity). Based on that sequence, they found a peptide (protein derivative) present in the thymus, which controls the body’s immune system. Nerofe is a peptide medical application used to cure a growing number of maladies associated with the immune system.

 

 

Professor Uziel Sandler

 

“It is an established fact that the thymus acts as a trigger and cause of debilitating autoimmune diseases, including rheumatoid arthritis and myasthenia gravis, a horrible muscle degenerative disease, as well as other diseases like Crohn’s,” Devary pointed out.

Upon making their discovery, Immune System Key registered five patents for Nerofe peptide derivatives. Initial clinical testing of Nerofe on mice (Phase I trials) showed a “high efficiency” of protecting mice against Crohn’s and leukemia. “The Nerofe peptide discriminates between healthy and sick cells, and delivers a knockout punch to the sick cells. We’ve also done numerous toxicology studies, and we know for a fact that even high doses of the drug will not cause side effects, which is the curse of many new medicines,” Devary added.

Human trials (Phase I) of Nerofe will be performed on patients with AML, an acute form of leukemia. Devary said, “There are several reasons why we want to do Nerofe trials on leukemia patients. First, the FDA will fast-track drug development for life-threatening diseases if Phase I clinical trials are successful. We want to try Nerofe on AML patients to see if there are any toxic side effects. Even though I’ve done toxicology studies, which show no side effects, we have to show the medical community and the FDA that this is the reality. If the human trial shows no toxic side effects, the evaluation of Nerofe will be sky-high. The whole business model and value of the company will increase. We also believe it will be successful in some forms of breast cancer. For Crohn’s, we are working on an oral treatment.”

Should Nerofe make it through the rigid trial phases, the revolutionary drug could be mass-marketed in about two years. 

Devary believes that Immune System Key’s initial success can be traced to the fact that he and his colleagues are thinking outside the medical box by utilizing novel research methods. But he also believes that there is unmistakable spiritual dimension to their successful discoveries. He modestly admitted, “Immune System Key and Nerofe is one big kiddush Hashem. The Almighty is giving us these successes because we are avreichim who devote a lot of time to learning Torah, granting us the wisdom to move forward and cure people.”             

Printed from: http://www.jewishpress.com/indepth/interviews-and-profiles//2008/12/29/

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