The article is based on announcements issued by the companies to the various stock exchanges
Ormed reports successful results in the trial of the oral insulin pill (ORMD-0801) for the treatment of type 1 diabetes patients
Ormed Pharmaceuticals, a pharmaceutical company in an advanced clinical stage that develops a unique technology for the oral administration of drugs that are currently given only by injection, today announced positive results in a clinical trial aimed at testing the pharmacokinetic response in the human body upon the administration of different doses of the company's product, an oral insulin pill (ORMD-0801 ) for the treatment of type 1 juvenile diabetes patients (Type 1).
Nadav Kidron, CEO of Ormed, said today that "these results add to the impressive results from past experiments in the treatment of type 1 diabetes patients with oral administration, and we continue to move forward with the indication in parallel with our advanced trials of the product in oral administration for the treatment of type 2 diabetes, in which results are expected this coming January" .
Type 1 diabetes (T1DM) is an autoimmune disease in which the body attacks the beta cells in the pancreas where insulin is produced, to the extent that patients are completely dependent on insulin from an external source. The number of patients with juvenile diabetes is increasing at a rate of about 3% per year, and these currently amount to about 36 million patients worldwide, about 10% of the total population of diabetes patients. The disease was known and recognized in the past mainly at a young age, but today it appears in both young and old populations.
Redhill Biopharma reports positive pharmacokinetic results supporting the phase III trial currently underway with RHB-105 (H. pylori)
The Israeli biopharmaceutical company, Biopharma RedHill, which develops patent-protected drugs in advanced clinical development stages, reports positive results in a pharmacokinetic trial with RHB-105, a patented combination in a capsule for oral administration, intended for the treatment of bacterial infection
Helicobacter pylori (H. pylori), a major cause of stomach inflammation, stomach ulcer, stomach cancer and MALT (mucosa associated lymphoid tissue) lymphoma.
The results of the pharmacokinetic trial, including the absorption characteristics in the body, the pharmacokinetic properties and the safety of RHB-105, are subject to additional quality tests and an independent final report that will be submitted by the Canadian CRO (Contract Research Organization) that conducted the trial. The final report is expected to be received in the coming weeks.
The pharmacokinetic trial, which was designed as an open label, randomized, two-armed trial in which the treatment is switched between the arms during the trial (cross over), was designed to examine the bioavailability and pharmacokinetic properties of the RHB-105 capsule, which contains three substances active, and compare them to sequential administration of the three active drug components separately. The second objective of the trial was to evaluate the safety of the RHB-105 combination in healthy volunteers.
The positive results of the trial support the continuation of the phase III trial with RHB-105 which is currently underway in the USA.
Gilad Redai, Senior Vice President for Products and Strategy at Redhill stated: "We are very satisfied with the positive results obtained in the pharmacokinetic trial with RHB-105. The results of the trial provide us with additional information about the pharmacokinetic properties of RHB-105 and demonstrate the high safety profile of the drug, and therefore support the continuation of the Phase III trial with RHB-105 and the potential for future commercialization of the drug."
Yes, Faith reports success in the results of a phase b2 trial in rheumatoid arthritis with the drug CF101
The Yes Fit Biopharma group, which develops drugs for inflammatory diseases and cancer, announced today the success of the results of a phase 2b trial in rheumatoid arthritis. The trial was double-blind and included 79 patients with active arthritis who were treated twice a day with CF101 as a single drug for 12 weeks in 1 mg tablets or placebo. All patients were tested pre-treatment for the presence of the biomarker which is the type A3 adenosine receptor and only those in whom a high level of the biomarker was found were included in the experiment. A total of about 70% of the tested patients were found suitable to be included in the experiment.
The results will be presented at the upcoming JP Morgan conference as well as at an international conference on autoimmune diseases to be held in March 2014.
Prof. Pnina Fishman, CEO of Yes Faith, said today: "We are very satisfied with the efficiency and safety obtained in this experiment. The results are in line with those obtained in the interim report of the trial we are conducting in the psoriasis disease and together indicate the high anti-inflammatory potential of the CF101 drug as well as the ability to use the A3 adenosine receptor as a biological marker that predicts the patients' response to the CF101 drug. We believe that on the basis of the excellent results obtained in this trial, we will advance the further development of the drug for the treatment of rheumatological diseases."
Intech Pharma received approval for a patent in the USA for the accordion pill for the release of a variety of difficult to dissolve drugs in the stomach
Intech Pharma, which is engaged in the improvement of existing drugs that are currently sold for hundreds of millions of dollars a year, is proud to report that it has received the approval of the US Patent and Trademark Office, the USPTO, for a patent that refers to and protects the accordion pill platform that includes openings in its outer layers and is suitable for hard-to-dissolve drugs. This granted patent provides patent protection for the next generation of the accordion pill until January 2027.
The patent, under the title "Method and Apparatus for Forming Delivery Devices for Oral Intake of an Agent" (Method and Apparatus for Forming Delivery Devices for Oral Intake of an Agent) is a continuation of the company's patent protection for the production method of the accordion pill, which was also granted to the company until 2027 (date which will be extended by an additional 699 days, in accordance with American law) and refers to and protects the patent of the accordion pill even in the new configuration that includes openings in the outer layers that allow the release of the hard-melting drugs in accordance with the unique capabilities of the accordion while controlling and controlling the rate and amount of drug administration.
The management of Intech Pharma stated today that "We are very proud and happy about the approval of the patent in the USA, which will now allow us to accelerate our activities for the development and adaptation of the accordion platform also for the benefit of improving hard to dissolve drugs. Improving the bioavailability and improving the blood level profile of hard to dissolve drugs is today considered one of the main challenges in the field of drug delivery in the pharmaceutical industry. Through the new patent, we were able to expand the scope of our patent protection for the accordion pill and significantly strengthen the company's intellectual property. The extensive and unique knowledge that we have developed in the production process of the accordion pill will be an excellent infrastructure for the company's entry into the strategic field of providing an oral response to hard to dissolve drugs."
Kadima Stem will invest NIS 8.5 million with the assistance of the chief scientist in the development of cellular therapy
The KadimaStem company, which develops technologies for scanning and developing drugs based on human stem cells, received budget approval from the chief scientist for two development programs in the total amount of NIS 8.5 million for the promotion of cell therapy and drug discovery for diabetes as well as for the development of drug discovery systems for neurodegenerative diseases.
The grant funds will support and assist KadimaStem in the further advancement of the company's innovative technology for the development of a regenerative medicine for diabetes and the production of pancreatic beta cells for the treatment and cure of diabetes, as well as for the continued development and strengthening of the drug scanning platforms developed by KadimaStem to discover drugs for neurodegenerative diseases such as Huntington's disease (HD), multiple sclerosis (MS) ) and terminal muscular dystrophy (ALS).
In accordance with the approval, Kadimastem will be given a grant according to a participation rate of 50% of the research and development expenses. In the project for cell therapy and the discovery of drugs for diabetes, a budget of up to NIS 5.285 million was approved, which focused on the development of tissue from embryonic stem cells for transplantation into diabetic patients. In the project to develop systems to discover drugs for neurodegenerative diseases, a budget of up to NIS 3.217 million was approved for the development of a system based on stem cells to discover drugs for diseases that originate from damage to the myelin layer.
Kadimastem recently reported on the signing of a memorandum of understanding to promote cooperation with the leading international pharmaceutical company Merck Serono in the field of drug discovery and screening based on stem cells.
Yossi Ben Yosef, CEO of Kadimastem stated that "We are very happy about the approval of two important development programs by the chief scientist in the fields of diabetes and the development of drugs for diseases of the nervous system.
Mazor - orders from Turkey and Florida for a robot for back surgery
Mazor Robotics reports receiving the first order for the Renaissance system from the company's distributor in Turkey, Cordamed Biomedical Engineering. In this way, Mazur wins the first order in Turkey for the robotic system that will be installed and used by a leading hospital in Istanbul.
Earlier, the company said that the Jacksonville Baptist Medical Center in Florida also ordered another Renaissance robotic system used for spine surgeries. Baptist Medical Center, which was recently ranked number one among hospitals in the region by US News & World Report, purchased the first Renaissance system in March of this year.
