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Pluristem has announced its pivotal Phase III clinical trial to treat critical limb ischemia received clearance from regulatory authorities in the United States, United Kingdom and Germany. Based on these clearances, the Company expects to begin enrolling patients in this study in the coming months.

Pluristem’s PLX-PAD cells will be evaluated in a double blind, randomized, placebo controlled trial in 250 patients.

The global market for treating critical limb ischemia is $12 billion globally. 1.7 million patients who live in world’s largest and most advanced pharmaceutical markets suffer from this limb-threatening and life-threatening disease. This number is expected to top 2 million in the next five years.

Pluristem’s critical limb ischemia program has been selected by the European Medicines Agency for its Adaptive Pathways pilot project. This allows for faster marketing approval in Europe after a single pivotal Phase III trial.

In the current Phase III trial, an interim analysis of data will be made for the first 125 patients, potentially leading to early marketing approval in Europe. Full enrollment is to be completed as planned to pursue full marketing approval in the U.S.

Regenerative medicines like PLX cells will have tremendous benefits on healthcare economics based on their efficacy and their non-invasive nature.

Can-Fite has reported that it is commencing patient recruitment in its global, pivotal Phase III trial of its lead drug candidate Piclidenoson in the treatment of rheumatoid arthritis.  The study, titled ACRobat, will enroll 500 patients in Europe, Israel and Canada.

The company reported drug supplies for trial have been manufactured and are ready for administration. The trial will have an estimated cost of $5 million, a modest cost when considering the global market for rheumatoid arthritis drugs is currently $38.5 billion.

Can-Fite’s drug is being developed as a first line therapy and replacement for the current standard of care, Methotrexate. Methotrexate is the most widely used drug for rheumatoid arthritis.

90% of rheumatoid arthritis patients receive Methotrexate at some point in their disease, but 40-50% of patients stop taking it after five years, due to its serious side-effects.

Over 1,000 patients have been safely treated with Piclidenoson, which has shown no series side effects and has proven to be safe. Piclidenoson can offer a superior alternative to Methotrexate for patients who need a safe and effective drug that can be taken long term.

You’ve seen it in movies and TV shows, but 3D replication is no longer a thing of the future. Host Annamaria Stewart stops by DOOB SoHo to step into their doob-licator full-body scanner and then heads to the company’s Brooklyn production facility to watch her custom action figure come to life through 3D printing.

This episode is currently airing on ClearVISION, an innovative in-airport TV network which features the best entertainment, news, music, and sports programming for travelers.

This series is part of the Huffington Post Outspeak Network.

In 1862, Ladurée opened the doors to their first bakery in Paris, France. In 1930, the French patisserie invented what would become their signature item, the macaron. In 2011, Ladurée finally arrived stateside with their first US location on Madison Avenue and in 2014 they opened their first North American tea salon in SoHo. Now Ladurée is opening up their kitchen to teach fans how to make their best selling pastry, the Ispahan. Host Annamaria Stewart heads to Ladurée SoHo’s pastry kitchen for a lesson from Executive Pastry Chef Jimmy Leclerc.

This episode is currently airing on ClearVISION, an innovative in-airport TV network which features the best entertainment, news, music, and sports programming for travelers

After 54 years and more than 20 studio albums, Exhibitionism – The Rolling Stones is finally giving fans the satisfaction they could never get, with a 17,000 square foot interactive exhibit packed with over 500 pieces of personal memorabilia, 190 original artworks, and 9 thematic galleries that are purely rock n’ roll. Host Annamaria Stewart speaks with Exhibitionism curator Ileen Gallagher about collaborating with the band members, The Stones’ iconic fashion, and recreating their Edith Grove flat.

This episode is currently airing on ClearVISION, an innovative in-airport TV network which features the best entertainment, news, music, and sports programming for travelers.

This series is part of the Huffington Post Outspeak Network.

In 2016 consumers will use their mobile phones to spend a total of 620 billion dollars and analysts expect this number to grow to over 1 trillion dollars by 2020. Hoping to capitalize on consumers preference for convenient transactions new payment technologies such as peer to peer payments, crypto currencies and digital wallets have seen rapid growth. In this special report, Corporate Profile® delves into the future of cashless technology with Shlomi Cohen the CEO of OTI (On Track Innovations www.otiglobal.com), a company which hopes to further change the way consumers pay with wearable payment devices.

TEL AVIV, Israel, December 7, 2016 /PRNewswire/ —

Kitov Pharmaceuticals Holdings Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late stage drug development, announced today that its lead drug candidate KIT-302 met the U.S. Food and Drug Administration’s (FDA) standards for establishing six months stability.

The study, conducted by Kitov’s manufacturing partner, Dexcel Pharma, demonstrated that nine pivotal batches of KIT-302, three in each dosage forms (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg, and 200 mg/2.5 mg) met the criteria demonstrating stability for 6 months. The successful stability study enables registration batches of KIT-302 to be included in the New Drug Application (NDA) submission which is planned during Q1 2017. The Certificate of Analysis demonstrated adequate stability required for submission, in accordance with FDA guidelines. Kitov expects to submit additional stability data to the FDA at a later time, in order to extend the labeled shelf life.

“We are very pleased with the stability study results, which we believe complete the testing required for our New Drug Application to the FDA for KIT-302,” stated Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer.

About KIT-302

KIT-302 is a fixed dose combination consisting of 200 mg of celecoxib, indicated for osteoarthritis pain, and 2.5, 5 or 10 mg of amlodipine, indicated for high blood pressure. It is intended to treat pain caused by osteoarthritis (OA), as well as simultaneously treat hypertension, which is a common side effect of certain stand-alone drugs that treat osteoarthritis pain, as well as a common concomitant preexisting condition. KIT-302 is comprised of two U.S. Food and Drug Administration (FDA) approved drugs, celecoxib (the active ingredient in Pfizer’s Celebrex®), for the treatment of pain caused by osteoarthritis and amlodipine besylate (the active ingredient in Pfizer’s Norvasc®), a drug designed to treat hypertension. Kitov expects to submit a New Drug Application for KIT-302, which successfully completed a pivotal Phase III trial, with the U.S. Food and Drug Administration during Q1 2017.

Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.).  Norvasc® is a registered trademark of Pfizer Inc.

About Kitov Pharmaceuticals

Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical company focused on late-stage drug development. Leveraging deep regulatory and clinical-trial expertise, Kitov’s veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial and its New Drug Application with the U.S. Food and Drug Administration is currently being prepared for submission. By lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.

New York may not be the city of lights but it has been home to over 100,000 neon signs over the years. Although only a handful of these historic signs remain, the art of neon is still alive in Tribeca at Let There Be Neon, one of the city’s last remaining neon craftsmen shops. Technology may change the standard for signage but neon has made a resurgence with artists, designers, and brands all gravitating towards this nostalgic light. Host Annamaria Stewart meets up Jeff Friedman, the owner of Let There Be Neon, who much like NYC is no stranger to neon signs.

This episode is currently airing on ClearVISION, an innovative in-airport TV network which features the best entertainment, news, music, and sports programming for travelers.

This series is part of the Huffington Post Outspeak Network.

HAIFA, Israel, Nov. 01, 2016 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, today announced that the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) has cleared Pluristem’s application to begin the pivotal Phase III trial of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI) for patients who are unsuitable for revascularization. Pluristem’s CLI program was previously selected by the European Medicines Agency (EMA) for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal Phase III trial.

The multinational Phase III trial will be conducted in the U.S. as well as Europe. The U.S. Food and Drug Administration (FDA) has previously given positive feedback on the trial protocol in a pre-Phase III interaction. Pluristem’s intention is to file a request for marketing authorization in the U.S. and in Europe following a successful completion of this 250-patient trial.

“Pluristem is very pleased to receive clearance to commence our pivotal Phase III CLI trial in the United Kingdom. We are eager to move forward to confirm efficacy of PLX-PAD cells in CLI, and anticipate receiving similar authorizations from additional regulators in Europe and the United States. Executing on an accelerated clinical development timeline, we anticipate commencing patient enrollment in the first half of 2017,” stated Pluristem Chairman and CEO, Zami Aberman. “We believe cell therapy holds great promise for patients with difficult to treat, life threatening conditions, such as CLI, and hope to play an important role in improving their health outcomes.”

The Phase III trial will evaluate PLX-PAD cells in the treatment of CLI in a double blind, randomized, placebo controlled trial. An estimated 250 patients with CLI Rutherford Category 5, who are unsuitable candidates for revascularization, will be enrolled. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM) two months apart. The primary endpoint will be time to amputation or death, allowing for a survival analysis that is well powered to deliver statistically significant results from a trial of this size.

About Critical Limb Ischemia
In CLI, fatty deposits block arteries in the leg, leading to greatly reduced blood flow. This causes leg pain at rest, non-healing ulcers and gangrene. Patients with CLI are at high risk for limb amputation and death within a year of diagnosis. While some conservative treatments exist to relieve pain and provide local ulcer care, most patients will ultimately need a revascularization procedure. Many, however, are not suitable candidates for revascularization, and have high rates of major amputations (up to 40% at six months from diagnosis).

PETACH TIKVA, Israel, Oct. 13, 2016 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory and liver diseases, cancer, and sexual dysfunction, today announced it has submitted the clinical trial protocol for its Phase II study of CF102 in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH), to a leading Institutional Review Board (IRB) in Israel. Top medical centers in Israel, including Hadassah Medical Center and Rabin Medical Center are expected to participate in the planned study by enrolling and treating patients.

“We are eager to commence our Phase II study in NAFLD/NASH, an indication for which there is no U.S. FDA approved drug. We view the submission of our clinical trial protocol as a major step forward,” stated Can-Fite CEO Dr. Pnina Fishman.

Based on the protocol that was submitted, Can-Fite’s Phase II study, designed by world renowned Key Opinion Leaders in the field of liver diseases, will be a multicenter, randomized, double-blinded, placebo-controlled, dose-finding study of the efficacy and safety of CF102 in the treatment of NAFLD/NASH. The study will enroll approximately 60 patients with NAFLD, with or without NASH, and will have three arms, including two different dosages of CF102 and a placebo, given via oral tablets twice daily. The study’s primary endpoints will be percent change from baseline in liver triglyceride (fat) concentration measured by nuclear magnetic resonance spectroscopy (NMRS) and safety. Secondary endpoints to be evaluated are the effects of CF102 on metabolic abnormalities in subjects with NAFLD, including body weight, waist circumference, serum triglyceride and high-density lipoprotein cholesterol levels, and serum liver transaminase. In addition, an assessment of the pharmacokinetics (PK) of CF102 and the A3 adenosine receptor (A3AR) biomarker will be evaluated prior to treatment and its correlation to patients’ response to the drug will be analyzed upon study conclusion. Furthermore, the exploratory objective of this study is to evaluate the effects of CF102 on relevant biomarkers, such as adiponectin, leptin, C-reactive protein (CRP), and liver stiffness as determined by Fibroscan. The trial design is based on preclinical studies showing CF102’s efficacy in reducing liver fat in NASH models as compared to placebo, improving liver function, and regenerating liver cells.

Deutsche Bank estimates the addressable pharmaceutical market for NASH will reach $35-40 billion in size by 2025.

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