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NEWTOWN, Pa., Jan. 23, 2020 (GLOBE NEWSWIRE) —Onconova Therapeutics Inc. (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), today announced that it has regained the rights to rigosertib in Greater China.  Onconova regained the rights from HanX Biopharmaceuticals (HanX) as a result of the termination of the Onconova-HanX License Agreement pursuant to its terms due to HanX failing to make required payments under the agreement.  In exchange for transition assistance and upon further regulatory, development and commercial progress in Greater China, HanX may be eligible to receive from Onconova incentive milestones and royalty payments.  The Greater China territory, including mainland China, Hong Kong, Macau and Taiwan, represents one of the key world pharmaceutical markets. 

“We are pleased to regain rigosertib rights for Greater China, and we are encouraged by the opportunity to partner rigosertib in select territories including Greater China as we approach the potential corporate catalyst of topline data for the registrational INSPIRE Trial in 1H 2020,” said Dr. Steven Fruchtman, President and Chief Executive Officer of Onconova.   “We thank HanX for their collaborative efforts to advance rigosertib in this key market including the filing of the rigosertib IND in China.”  Dr. Fruchtman continued, “In 2019, we added partners Knight Therapeutics for Canada, Specialised Therapeutics for Australia & New Zealand, and Inceptua Medicines Access in select countries for pre-approval access to our roster of global corporate partners, joining Pint Pharma for Latin America and SymBio Pharmaceuticals for Japan & Korea.  The United States, Europe, and Greater China represent the major pharmaceutical markets Onconova directly controls heading into INSPIRE data read out.” 

About Onconova Therapeutics, Inc. 

Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with an initial focus on Myelodysplastic Syndromes (MDS).  Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells.  Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS.  Onconova has conducted trials with two other research compounds and has a pre-clinical program with a CDK4/6 and Ark5 inhibitor, ON 123300.

For more information, please visit http://www.onconova.com. 

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow.  This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them.  Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia).  Patients with higher-risk MDS may progress to the development of acute leukemia. 

About Rigosertib

Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule.  A key publication in a preclinical model demonstrated rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: “A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling.” Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients (Phase 2).  Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037. 

About the INSPIRE Phase 3 Clinical Trial

The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency.  INSPIRE is a global, multi-center, randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment.  This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines.  Patients are randomized at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care.  The primary endpoint of INSPIRE is overall survival.  The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443). 

• Study met primary endpoint of at least 75% improvement of skin inflammation
• Safety profile was consistent with the known safety findings of baricitinib in atopic dermatitis (AD)
• Study was conducted outside of the U.S. and is the first and only report of a JAK inhibitor in patients who failed, were intolerant, or contraindicated to cyclosporine

INDIANAPOLIS, Jan. 24, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today that baricitinib met the primary endpoint in BREEZE-AD4, an investigational Phase 3, randomized, placebo-controlled study evaluating the safety and efficacy of baricitinib in combination with topical corticosteroids (TCS) for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who were inadequate responders, intolerant or had contraindication to treatment with cyclosporine. The primary endpoint was defined by the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at Week 16.

“There is a high need for additional treatment options for patients living with moderate to severe AD, particularly those who failed conventional systemic treatments like cyclosporine,” said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. “As we look to progress our treatment portfolio for chronic skin conditions, the continued insights from the development program in AD further the potential of baricitinib to pursue this indication and to reach patients.”

BREEZE-AD4 is a multicenter, double-blind, randomized, placebo-controlled study conducted outside of the U.S. The study evaluated the efficacy and safety of the 1-mg, 2-mg and 4-mg doses of baricitinib in combination with TCS in patients with moderate to severe AD who have experienced failure to cyclosporine or are intolerant to—or have contraindication to—cyclosporine. In this study, the 4-mg dose of baricitinib plus TCS met the primary endpoint as defined by the proportion of participants achieving EASI75 at Week 16.

The safety profile was consistent with the known safety findings of baricitinib in AD. The most common treatment-emergent adverse events (TEAEs) included nasopharyngitis, headache, and influenza. No venous thromboembolic events (VTEs) or deaths were reported in the trial.

Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate to severe atopic dermatitis and plans to submit for approval in the U.S. and Japan in 2020. Full results from the BREEZE-AD4 study will be disclosed at future scientific venues and in peer-reviewed journals.

Baricitinib is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in more than 60 countries, including the U.S., member states of the EU and Japan, and is marketed as OLUMIANT^®.

Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients
OLUMIANT^® (baricitinib) 2 mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS

WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

• Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. Treatment for latent infection should be considered prior to Olumiant use.
• Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
• Bacterial, viral, and other infections due to opportunistic pathogens.

Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

Bayer and Orion’s prostate cancer drug Nubeqa (darolutamide) is gaining steam in its battle against rivals from J&J and Pfizer/Astellas as Japan becomes the latest country to approve the drug.

The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorisation to Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC). 

In Japan, over 89,000 men are estimated to be diagnosed with prostate cancer annually, making it the second most-common cancer diagnosis in Japanese men (after stomach cancer). 

The drug was approved by the FDA in July last year. With darolutamide, Bayer is hoping to take market share from J&J’s Erleada (apalutamide) and Pfizer/Astellas’ Xtandi (enzalutamide), which have become standard therapies at several different stages of the disease.

Bayer and Orion think that their drug may have a safety advantage over competitors and is tipped to break through the billion-euro annual sales barrier.

Analysts agree that the side effect profile is favourable based on trial data so far, but efficacy is comparable and this may not be enough to win over prescribers looking for an improvement on the rivals, which have only recently been approved in this use.

The Japanese approval, like the US greenlight, is based on data from the phase 3 ARAMIS trial in men with non-metastatic castration-resistant disease, which showed a statistically significant improvement in metastasis-free survival for darolutamide plus androgen deprivation therapy (ADT).

In ARAMIS, 1,509 patients were randomised in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.

The trial showed that Nubeqa plus androgen deprivation therapy (ADT) demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT group.

J&J’s Erleada was first to market in this indication, approved in February last year after data in the SPARTAN trial showing MFS of 40.5 months, compared with 16.2 months in patients taking placebo.

Pfizer/Astellas’ rival Xtandi was approved in the same indication shortly after – in the PROSPER trial MFS was 36.6 months for those treated with Xtandi plus ADT, compared with 14.7 months in those treated with placebo and ADT.

Bayer is also developing darolutamide in metastatic hormone-sensitive prostate cancer, where the phase 3 prostate cancer trial ARASENS is testing its safety and efficacy.

With the world watching at the World Economic Forum in Switzerland, AstraZeneca announced a bold plan to have zero carbon emissions from its global operations within the next five years. That would accelerate the company’s “decarbonization” plan by more than a decade.

AstraZeneca’s “Ambition Zero Carbon” strategy will accelerate the company’s already-existing sustainability plans. Included in the company’s plan is a doubling of energy productivity and using renewable energy for both power and heat, as well as switching to a 100% electric vehicle fleet. The goal is to have this completed by 2025 and the price tag is expected to cost about $1 billion.

Not only does AstraZeneca intend for its operations to have zero carbon emissions, the company is also looking to develop next-generation respiratory inhalers for asthma and COPD that do not add to global warming with the propellants used. AstraZeneca expects the propellant used in the next generation pressurized metered-dose inhalers to have a global warming potential that is 90% to 99% lower than propellants used in older inhalers. In addition to offering next-generation inhalers, AstraZeneca will continue offering dry powder inhaled medicines, the company said.

Also, the company intends to embark on a 50-million tree reforestation initiative that will be rolled out over the next five years. The first trees are expected to be planted in Australia later this year, with France, Indonesia and other countries to follow, AstraZeneca said. “Ambition Zero Carbon” sets out to make AstraZeneca’s global operations responsible for zero carbon emissions without relying on offset schemes to reach zero emissions on aggregate, the company said.

AstraZeneca Chief Executive Officer Pascal Soriot said climate change is an urgent threat to public health, as well as the environment and the sustainability of the global economy.

“Since 2015, we have reduced our carbon emissions from operations by almost a third and our water consumption by almost one fifth. But now is the time to act even faster and redouble our efforts. The commitments AstraZeneca has made today as part of our ‘Ambition Zero Carbon’ strategy will enable us to speed up the reduction of our Company’s impact on climate and inspire collaboration at a global level to affect policy change,” Soriot said in a statement.

Not only will AstraZeneca look to significantly reduce its own carbon footprint, the company said it will also ask its suppliers to curb their own carbon footprint so the company can achieve a goal of being carbon negative along its entire value chain by 2030.

Earlier this year, AstraZeneca was recognized by Corporate Knights as one of the world’s 100 most sustainable companies.

AstraZeneca isn’t the only pharma company focused on being a better environmental steward. Last year, Novo Nordisk said it was close to hitting its goal of relying on renewable energy by this year. The company first set its sights on achieving zero carbon dioxide emissions in its global manufacturing in 2015. As part of its plan, Novo Nordisk invested in a 672-acre solar panel installation, roughly the size of 500 football fields, in North Carolina. That solar panel facility is expected to provide power to Novo Nordisk’s entire U.S. operations by early 2020.

Earlier this month at the J.P. Morgan Healthcare Conference, Takeda said it exceeded its previously established 2020 environmental goals ahead of schedule, including reducing its CO2 emissions by 33.7% compared to 2005 levels. Takeda also set a carbon neutrality goal across its value chain for 2040.

TOKYO, Jan 23, 2020 – (JCN Newswire) – Eisai Co., Ltd. has obtained the approvals of supplementary new drug applications in Japan for its in-house developed antiepileptic drug (AED) Fycompa (perampanel) for an additional indication for monotherapy of partial-onset seizures and an additional indication for partial-onset seizures in pediatric patients aged 4 years and older, as well as a new fine granule formulation.

The approval for monotherapy for partial-onset seizures is based on the results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea. The outcome achieved the primary endpoint, with the rate of complete seizures-free exceeding the initially established efficacy criteria* in monotherapy for untreated epilepsy patients aged 12 to 74 years with partial-onset seizures. The most common adverse events (incidence of 10% or higher) observed in this study were dizziness, somnolence, nasopharyngitis, and headache, which were consistent with the safety profile of Fycompa to date.

The additional approval covering partial-onset seizures in pediatric epileptic patients 4 years of age and older is based on the results of a Phase III clinical study (Study 311) of Fycompa, as adjunctive therapy in pediatric patients, conducted in Japan, the United States and Europe. This study showed that the safety and efficacy of Fycompa combination therapy in pediatric epilepsy patients with poorly controlled partial seizures (ages 4 to less than 12 years) were similar to those in patients aged 12 years and older.

The additional approval for the fine granule formulation is based on the results of a bioequivalence study of fine granules and tablets conducted in Japan. Eisai developed this formulation to make it easier to administer Fycompa to children and patients who have difficulty taking tablets. The study confirmed the bioequivalence of fine granules and tablets.

Fycompa is a first-in-class AED and a once-daily oral drug discovered at Eisai’s Tsukuba Research Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Fycompa has been approved in many countries around the worldwide as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older and as an adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. In the United States, Fycompa is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.

The number of epilepsy patients in Japan is estimated to be approximately 1 million, and it is possible that the disease may occur regardless of age group, but it is said that the incidence is particularly high in children and the elderly. Eisai considers neurology including epilepsy as a priority disease area, and provides information on the appropriate use of Fycompa, aiming to satisfy the diverse needs of patients and their families and offer improved benefits. With the approval for monotherapy, pediatric indication aged 4 years and older and fine granule formulation, Eisai will continue to prioritize the provision of safety information. Furthermore, Eisai will pursue its mission of delivering “seizure freedom” to as many patients as possible.

*The criteria for efficacy in this study with 73 patients for evaluation of efficacy required a 52.1% or higher proportion of patients to have achieved seizure freedom, which was set primarily in consideration of the results from other AED monotherapy studies.

About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.

In its medium-term business plan EWAY2025, Eisai is aiming to become a “Medico Societal Innovator” (a company that changes society through creating medicines and providing solutions), and is working on establishment of ecosystem platform business utilizing various data such as a large amount of clinical data, experiences, and know-how.

One year ago, Takeda wrapped up its acquisition of Shire plc, which created one of the largest drug developers focused on rare diseases. Over the past year, the company strived to transform itself into becoming a frontrunner in multiple areas, including cell and gene therapies.

During the company’s 2019 R&D Investor Day, Takeda highlighted the importance of gene and cell therapies as it moves forward in its continued transformation from the Shire deal, as well as other collaborations the company has forged since. However, in what might be considered a refreshing moment of real honesty, Andy Plump, Takeda’s head of R&D, recently noted that sometimes being on the cutting edge of treatments does not mean your treatment will be the top-selling preference. In an interview with the Boston Business Journal, Plump revealed that he did not believe the company’s hemophilia A gene therapy treatment would be a market leader. In fact, he went so far as to say the treatment would probably not even be a contender.

“I think the likelihood is that our hemophilia A gene therapy is not going to be a competitor in the market… But I don’t think you need to be a frontrunner in a field to really be effective. In fact, I think, sometimes in the world we live in, being the frontrunner can have disadvantages,” he told the Journal.

In its gene therapy pipeline, Takeda is developing TAK-754 for hemophilia A. The asset is currently in a Phase I study. The company also has TAK-748 in preclinical studies for treatment of hemophilia B. As the Journal reported, the company sees a strong future for its gene therapy programs and considers them a future driver of business. While the Journal’s article did not go into specifics as to why Plump feels that the company’s gene therapy won’t be a market driver in hemophilia, it’s likely due to the fact that it is still in the early stages of development. Spark Therapeutics, a division of Roche, is moving its gene therapy treatment into late-stages of study following highly impressive data that showed a one-time treatment yielded a 97% response ratein reduced bleeding events in hemophilia A patients. When Roche made its bid for Spark, the Swiss pharma giant saw that company’s gene therapies for hemophilia as a complement to its own products for the bleeding disorder, including hemophilia treatment Hemlibra.

While the hemophilia treatment may not be a competitor in the marketplace, Plump told the Journal that Takeda is looking at bringing nearly a dozen treatments to market by 2024. Those treatments are aimed at conditions such as “cytomegalovirus infections, a rare disease called Hunter Syndrome and complications of premature birth.” Takeda believes these therapies can drive a combined $10 billion in peak sales, the Journal said.

In September, Takeda published the results of a Phase II study of TAK-620 (maribavir) for cytomegalovirus (CMV). The drug is designed to target a specific CMV protein, which may lead to inhibition of CMV DNA replication and encapsidation.

Additionally, Takeda has remained busy inking collaborations with multiple companies to advance its drug development programs. Earlier this month, the company struck a multi-year drug discovery deal with Charles River Laboratories. The companies will develop potential drug candidates across Takeda’s four core therapeutic areas—oncology, gastroenterology, neuroscience and rare disease. Only weeks prior to the deal with Charles River, Takeda forged a collaboration worth up to $1 billion with Turnstone Biologics to tackle a number of cancer indications using that company’s vaccinia virus platform. The company and Cerevance teamed up to tackle diseases of the gastrointestinal tract that have their roots in the central nervous system.

Ireland’s Horizon Therapeutics became the first to win regulatory approval in the United States for the treatment of Thyroid Eye Diseases, a progressive autoimmune disorder that can threaten the vision of those afflicted.

Tuesday afternoon the U.S. Food and Drug Administration (FDA) approved Tepezza(teprotumumab-trbw) as the first treatment for this condition. The regulatory agency approved the medication weeks ahead of its March 8, PDUFA date. It was approved under Priority Review and had received Orphan Drug, Fast Track and Breakthrough Therapy designations from the FDA.

Tepezza is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is administered to patients once every three weeks for a total of eight infusions. The approval was based on strong clinical data that showed improvements in patients as early as six weeks, as well as continued improvement across the entire 24-week course of treatment. In a Phase III study, patients treated with Tepezza saw an 82.9% improvement in proptosis (eye bulging) compared to placebo, which demonstrated a 9.5% improvement. Also, the drug posted a 67.9% improvement from baseline in diplopia (double vision) compared to 28.6% of patients receiving placebo. The company said an analysis of both Phase II and Phase III data showed more patients with complete resolution of diplopia among those treated with Tepezza compared with placebo, 53% to 25%, respectively.

Timothy Walbert, chairman, president and chief executive officer of Horizon, said the TED (Thyroid Eye Disease) community has gone too long without an approved treatment to approve the disease, which is associated with eye-bulging, double vision, pain, inflammation and facial disfigurement. Not only are TED patients finally getting an approved treatment, but the approval is also important for Horizon, Walbert said. He noted that the approval of Tepezza “marks the early approval of Horizon’s first Biologics License Application – a key step in our evolution to an innovation-focused biopharma company, developing new medicines for debilitating diseases with few or no treatment options.”

Although TED is a rare disease, up to 50 percent of patients with Graves’ disease, the most common autoimmune disorder, will develop TED. Graves’ disease is a disorder that results in the overproduction of thyroid hormones.

Wiley Chambers, deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, said the Tepezza has the potential to alter the course of the disease and could spare the patients from the need for multiple invasive surgeries.

“Additionally, thyroid eye disease is a rare disease that impacts a small percentage of the population, and for a variety of reasons, treatments for rare diseases are often unavailable. This approval represents important progress in the approval of effective treatments for rare diseases, such as thyroid eye disease,” Chambers said in a statement.

As a result of the FDA approval of Tepezza, Horizon will make approximately $105 million in milestone payments during the first half of 2020.

Following the approval, Horizon said it will conduct a post-marketing study to evaluate safety in a larger patient population, which was discussed during advisory committee meetings ahead of the FDA’s approval. This study will also evaluate retreatment rates relative to how long patients receive the medicine, the company said.

Horizon anticipates having the drug available for TED patients within the next several weeks. The treatment will have a list price of 14,900 per vial, according to a Reuters report.

• World’s First Application of 5G Technology in Medical Practice
• Sync Cams Share Real-Time HD Video Footage of Surgery for Teaching
• 5G Network Base Made Secure for Medical Service Development
• Enterprise-Dedicated 5G Network Protects Private Medical Info from Hacking

SEOUL, South Korea, Jan. 20, 2020 /PRNewswire/ — KT Corporation (KRX: 030200; NYSE: KT), Korea’s largest telecommunications company, and the Samsung Medical Center (SMC) announced last week that they have jointly developed an innovative, 5G-powered medical service as an initial step to establishing a 5G smart hospital.

For the pilot project, KT built an enterprise-dedicated 5G network at the SMC, created service environments in operating and proton therapy rooms, and conducted a test operation. Based on the project’s outcome, the two parties plan to continue to develop smart patient care and 5G-powered innovative medical practices and improve hospital operational efficiency.

“KT, in partnership with the Samsung Medical Center, is pioneering innovative medical services for the new 5G era,” said Park In-Young, Vice President of KT’s ICT Convergence Business Department. “We will continue to further refine 5G-powered medical technology by applying VR and AR technologies for real-time education.”

The two partners have been applying 5G on site to create better medical services since they signed a memorandum of understanding in September 2019. These services include digital diagnostic pathology, access to proton therapy information, teaching surgery, an artificial intelligence-enabled care for in-patients, and an autonomous robot for an operating room.

Access to Digital Data and Video Footage

The 5G-powered digital pathological analysis conducted by SMC is a world-first example of innovation using 5G technology for on-site medical procedures.

In diagnostic pathology practiced up to now at one of Korea’s biggest hospitals, tissues taken from the patient during surgery were treated for analysis and sent to pathologists in an adjacent room. This required up to 20 minutes of walking back and forth, making it difficult for pathologists to conduct on-site group analyses.

Speedy and uninterrupted access to pathological data obtained during surgery, which is critical in determining the conditions of patients, is provided by a 5G network with ultra-high speed and ultra-low latency. The network allows the Pathology Department to gain access to materials, each containing about 4GB of data, ensuring better medical services.

The network also provides speedy access to CT and MRI data on proton therapy. The procedure required the pathologists to walk about a kilometer to the proton therapy center to download the files. Now, the 5G network enables them to access the files from anywhere within the medical center.

Surgery Education Away from the Operating Room

Operating rooms are too crowded with surgeons, nurses and medical equipment for medical students to observe closely. Resolving the hurdle to effective teaching, KT has developed a 5G-assisted education program in cooperation with the Samsung Medical Center.

The program enables surgeons in operating room to teach a large group of medical trainees in a separate lecture room, using sync cams on the 5G network. It provides voice and high-quality video footage from the perspective of the surgeons in real time.

Robots for Operating Room Assistance; AI for In-Patient Care

A delivery robot developed for operating rooms can remove contaminated materials and other medical waste for disposal. The autonomous robot can also bring in surgery supplies.

Robots for operating room assistance will reduce secondary and tertiary infection which occurs through contact with medical waste and save human resource costs in waste disposal. Moreover, 5G-enabled massive connectivity minimizes disruption and latency in data exchange with robots and terminals.

Smart Care Giver is an innovative AI-assisted system of in-patient care. It provides AI services on KT’s GiGAGenie engine, enabling patients to control their hospital room with a voice command, and with their permission checking their medical condition. Hence the medical staff can respond more efficiently to patient emergencies.

5G-Powered Smart Hospital

Collaboration between KT and the Samsung Medical Center will continue beyond the development of innovative medical service during this year.

“Based on the verified new services, we will continue our collaboration with KT to promote convenience for all of our customers, including patients, medical staff and visitors,” said Professor Park Seung-Woo, who is in charge of the smart hospital project at the SMC.

MEDIA CONTACTS
For inquiries, please contact our Global Media Relations Team at kt.gmrt@gmail.com

ABOUT KT CORPORATION (KRX: 030200; NYSE: KT)

KT Corporation, Korea’s largest telecommunications service provider, is leading the era of innovations in the world’s most connected country. The company is leading the fourth industrial revolution with high speed wire/wireless network and new ICT technology. KT launched the world’s first nationwide commercial 5G network on April 3, 2019, after successfully showcasing the world’s first trial 5G services at the PyeongChang Winter Olympic Games in February 2018. This is another milestone in KT’s continuous efforts to deliver essential products and services as it aspires to be the number one ICT Company and People’s Company.

SUZHOU, China, Jan. 20, 2020 /PRNewswire/ — TenNor Therapeutics, a clinical-stage, global biopharmaceutical company has received FDA Orphan Drug Designation for TNP-2092 to treat prosthetic joint infections.

Medical devices such as prosthetic joints, central venous catheters and artificial heart valves are being used more frequently and biofilm infections associated with them have become a major challenge. Biofilm infections are extremely hard to treat and often require surgical intervention plus prolonged antibiotic therapy, leading to high cost and major impact to patient’s quality of life. TNP-2092 is a multitargeting drug conjugate, exerting antibacterial activity by inhibiting three essential targets in bacterial biofilms: RNA polymerase, DNA gyrase and topoisomerase IV. TNP-2092 has demonstrated strong bactericidal activity, low frequency for development of resistance and an excellent safety profile. TNP-2092 has shown better efficacy than standard of care in a variety of animal models of bacterial biofilm infections.

TenNor has previously received FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for TNP-2092. Recently, TenNor has completed a Phase II clinical trial for TNP-2092 in the United States for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and received positive results.

About TenNor Therapeutics

TenNor Therapeutics is a clinical stage global biopharmaceutical company dedicated to development of differentiated products for the treatment of rare diseases associated with bacterial infections. TenNor possesses a strong new drug development portfolio, targeting medical device associated bacterial biofilm infections, cirrhosis hepatic encephalopathy and Helicobacter pylori infection, to address unmet medical needs in these areas.