Comprehensive coverage

Biotechnology Cluster: Pluristem received the approval of the US Registrar for a key patent of the company

And more in the cluster: a patent for bioline to produce stem cells; Approval by the Ministry of Health for Medigus for chronic heartburn treatment systems; Kitov signed a production agreement for the clinical trial; Alcovera reports positive results in drug for fragile X syndrome

Biotechnology. Illustration: shutterstock
Biotechnology. Illustration: shutterstock

The materials in this news are based on the companies' press releases and their responsibilities. Presented as a public service.

The Israeli biomedical company Pluristem announced on the eve of the holiday (Wed) the completion of a key step in the company's intellectual property protection strategy: the US Patent and Trademark Office granted the company protection for the treatment methods for peripheral arterial disease (PAD) using adherent stem cells from the placenta. In doing so, the patent office actually grants the company exclusivity for the use of stem cells from the placenta in the US for peripheral vascular diseases. Today, the development of medicines from placental cells for coronary artery diseases is one of Pluristem's main areas. This is the 26th patent approved for the company in the world and it is valid at least until 2028.

Zami Aberman, CEO of Pluristem, said today: "This is an important milestone in the company's intellectual property strategy, which advances us to the vision we have set for ourselves - to be a world-leading Israeli company in the development and production of cellular medicines. We believe that the patent in question is an important asset for the company and is a significant boost to our competitiveness in the world of cellular medicine."

Bioline has been granted a patent to produce stem cells for use in bone marrow transplantation

Bioline announced receiving approval from the US Patent and Trademark Office (USPTO) for the granting of a patent for the use of the drug BL-8040 to produce stem cells for use in bone marrow transplantation.

The patent will be valid until at least November 2029 and joins BL-8040's expanding patent portfolio, which includes six additional composition patents and 29 patent applications worldwide for new labels. This patent portfolio provides broad proprietary protection for BL-8040.

Bioline earlier announced receiving orphan drug status for BL-8040. Orphan drug status is granted to drugs intended for the treatment of rare diseases, in which the number of patients is less than 200 thousand people in the USA. Orphan drug status gives the company developing the drug exclusivity in marketing the drug for a period of seven years, and entitles it to receive assistance in managing and submitting the clinical protocol to the FDA, as well as federal grants and tax benefits.

Dr. Kinneret Soitsky, CEO of Bioline R. X: "We are satisfied with the approval of the US Patent Office for this patent on the method of producing stem cells by administering BL-8040. This approval strengthens our patent protection for this promising drug. BL-8040 is currently in a Phase 2 clinical trial for the treatment of acute myeloid leukemia (AML). Partial results in the trial are expected towards the end of the year. Broad and strong patent protection is a basis for the continued development of additional diverse oncological and hematological indications."
Dr. Soitsky added: "We are very happy to receive orphan drug status for BL-8040, which will advance the development process of one of our leading assets in the portfolio of products that are in clinical development stages."

Approval of the Ministry of Health for Medigus for chronic heartburn treatment systems

Medigus, a company in the field of medical devices engaged in the development and marketing of endoscopy-based medical procedures, announced today that it received approval from the Israeli Ministry of Health for registration in the register of medical accessories and devices for the SRS™ system for the treatment of chronic heartburn (GERD - gastroesophageal reflux) in Israel (approval from the Ministry of Health) r). In addition to the approval of the AMR, Medigus has FDA approval for the marketing and sale of the system in the USA, CE approval for the marketing and sale of the system in the EU countries and marketing approval in Canada from Health Canada.

The approval of the AMR for the system is a condition for the purchase of medical equipment by medical institutions and health funds in Israel. In addition, its acceptance is expected to advance the process of obtaining regulatory approvals in other countries, including the approval of the regulatory authorities in China (SFDA), where the company has a distribution agreement in the amount of approximately 4 million dollars with Sinopharm, the government distributor.

The SRS system was developed by Medigus and was found to be effective and safe as a minimally invasive, minimally invasive replacement therapy for invasive surgery, which is the common (gold standard) treatment today for chronic heartburn among severely ill patients. This is, among other things, by demonstrating a similar tissue placement after the procedure, performing a simpler procedure without pain and with a short recovery time. Medigus is currently in the initial stages of marketing the SRS system in the US and Europe, both independently and through distributors.

Dr. Elazar Sonnenshein, CEO of Medigus, said: "We are happy and excited to announce the receipt of the approval of the AMR for the marketing of the SRS system in Israel. Getting the approval is a natural development of our strategy. The Israeli market is an important and advanced market, the thirst for technological innovations in the various fields of medicine and the adoption of advanced treatment methods with high standards of efficiency and safety. Obtaining the approval of the AMR will help us in advancing the process of obtaining SFDA approval for marketing in China, which requires approval for marketing in the country of origin. The SRS system and the technology on which it is based, receives sympathetic responses among doctors specializing in gastroenterology and minimally invasive medicine in Israel. Now, with the approval of the AMR, we look forward to the start of activities with them and conducting procedures through the system."

Kitov signed a manufacturing agreement for the phase III clinical trial

The Kitov company announced that as part of the company's continued preparation for the Phase III trial of the KIT-302 product, which is expected to begin during the first half of 2014 and end towards the last quarter of 2014, the company entered into an agreement with Sterling Pharma to manufacture the drugs that will be supplied to the various groups during the trial.

Sterling Pharma is an American company that provides a full basket of services for drug production and formulation development. Sterling has FDA-approved manufacturing facilities within which dozens of drugs that have been successfully approved for marketing by the FDA have been developed and manufactured.

According to the agreement, Sterling will manufacture for the company, through over-encapsulation (embedding an existing and approved drug for use inside a new and unidentified capsule for the purpose of a clinical trial), the various drugs that will be supplied to the various groups in the pivotal Phase III clinical trial. As part of the agreement, Sterling will produce for the company the drug in the amount needed for the trial and will perform for the company the stability tests, release, packaging and delivery to the sites where the trial will be conducted.

Dr. Paul Vaimak, Kitov founder, chairman of the board and the company's medical director, stated: "The agreement with Sterling Pharma, which joins the agreements signed earlier this week with DABL, Pan Pharma and Paul Graham, will allow Kitov to move quickly towards the start of the phase III clinical trial of the combination drug of the company, KIT-302, already during the first half of 2014. We received far-reaching concessions from the FDA that allow us to conduct a short, focused and relatively cheap trial, in contrast to normal Phase III trials that sometimes last for years and have a very high cost. This is a golden opportunity that pharma companies don't get every day and we intend to take this opportunity with both hands and perform the trial to the highest standards available today. Therefore, we entered into agreements with world-renowned leading suppliers in order to maximize the chances of the experiment's success."

Alcovera reports significant positive results using MG01CI in a preclinical study in autism

Alcovera, which focuses on the development and commercialization of the drug MG01CI (Metadoxine in delayed release) for the treatment of cognitive disorders, announced substantial success and significant positive results in a preclinical study of Fragile X syndrome, a neurodevelopmental genetic disorder, which is the most common cause of all known genetic causes of cognitive disorders The autistic spectrum. The results of the research carried out by the company show a significant improvement in cognitive and social function following treatment using the company's unique drug MG01CI (Metadoxine in delayed release) in an animal model (FMR1 knock-out mouse model).

The study included several behavioral assessments in a valid life model for fragile X syndrome. The results of the study show a significant behavioral improvement in memory, learning abilities, attention and social interaction, as well as learning and persistence. All evaluations were performed in comparison to a placebo control and in a blind fashion - the raters were not aware of the treatment that each mouse received (MG01CI or placebo).

Dr. Yaron Danieli, president and CEO of Alcobra, said: "We are excited by the new findings presented as part of the experiment. Accordingly, we are exploring the opportunity to further develop MG01CI for this syndrome and even for other autism-related disorders. This is a substantial and important clinical need, and despite this, to this day not a single drug has been approved for this severe disorder."

The US Food and Drug Administration (FDA) has not yet approved any drug specifically designed to treat fragile X syndrome or its characteristics.

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