web analytics
January 21, 2017 / 23 Tevet, 5777

Posts Tagged ‘FDA’

Israeli ALS treatment Gets ‘Fast-Track’ FDA Designation

Saturday, October 11th, 2014

(JNS.org) Stem cell treatment developed by Israeli company BrainStorm Cell Therapeutics has been designated by the U.S. Food and Drug Administration (FDA) as a “fast-track” treatment of amyotrophic lateral sclerosis (ALS).

The treatment, called NurOwn, is currently undergoing mid-stage clinical trials in Jerusalem and in the U.S. on patients with ALS, which is also known as Lou Gehrig’s Disease. The FDA’s designation will speed up patients’ access to the treatment.

“The receipt of fast-track designation from the FDA is an acknowledgement of the unmet medical need in ALS,” BrainStorm Chief Executive Tony Fiorino said Tuesday, according to Reuters. “What is so valuable about fast track designation to a small company like BrainStorm is the opportunity to have increased meetings with and more frequent written communication from the FDA,” he said, adding that few other cellular therapies have received FDA approval.

The ALS Association reports that 5,600 people in the U.S. are diagnosed each year with the disease.

JNS News Service

New Cancer Drug Uses Immunotherapy to Treat Metastatic Melanoma

Tuesday, September 16th, 2014

Researchers have come up with a new treatment to fight metastatic melanoma – a fierce form of cancer that is particularly difficult to overcome. The new medication, called Keytruda, works on the body’s immune system and just received approval from the U.S. Food and Drug Administration (FDA).

Keytruda, produced by the Merck pharmaceutical firm in the United States, does not focus on destroying the cancerous tissue with chemicals, but rather initiates a different process in the body’s natural immune system, which then attacks the cancerous cells on its own.

The treatment mechanism is called “immunotherapy” and if it lives up to its expectations, the world of oncology could see a new revolution within just a few years. One of the clinical trials is being carried out at Tel Aviv’s Sheba Hospital at Tel Hashomer Medical Center.

Some 250 of newly diagnosed melanoma patients in Israel per year suffer from metastatic tumors. Malignant melanomas usually start on the skin but can also start elsewhere. Israel ranks among the 20 nations in the world with the highest morbidity rates for the disease, according to the International Agency for Research on Cancer.

“The new drug creates real potential for curing one of the deadliest forms of cancer at the negligible cost of light and tolerable side effects,” commented Prof. Jacob Schachter, head of the Ella Institute for Melanoma at Sheba Hospital. “Moreover, it completely alters the working assumptions in oncology treatment, as its working mechanism is effective in the war against other types of cancer too. There’s no doubt today that the holy grail of oncology lies in immunotherapy, which helps the body’s immune system to destroy the tumor’s cells itself.

“At this stage, we can only imagine the therapeutic potential of a combination of a number of such drugs, each acting on a different system, and some of which are already at an advanced stage of development. Among doctors, too, the scope of the breakthrough has yet to be digested.”

Hana Levi Julian

Teva Wins FDA Approval for Leukemia Drug

Thursday, February 13th, 2014

The U.S. Food and Drug Administration (FDA) has granted Israeli-based Teva Pharmaceuticals full approval for Synribo, a drug that is injected for adults with a with chronic phase or accelerated phase of myeloid leukemia.

Chronic myeloid leukemia, also known as chronic myelogenous leukemia, is one of four main types of leukemia and is a cancer of the blood and bone marrow.

The FDA had given initial approval for the drug in October 2012 but said Teva had to provide additional clinical trial data before it could bring the drug to market.

“With this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of Synribo, we believe healthcare providers can be even more confident in the clinical profile of this important medicine, said Teva president and CEO global specialty medicines Rob Koremans.

Jewish Press News Briefs

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.

Jewish Press News Briefs

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.

Malkah Fleisher

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.”             

Steve K. Walz

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

Scan this QR code to visit this page online: