Summary of research progress in the field of liver diseases (02.03)
February 05, 2018 Source: WuXi PharmaTech
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Galectin Therapeutics recently announced that its leading compound, GR-MD-02, has obtained two new patents in China and Japan. The coverage period of these patents continues until 2032.
GR-MD-02 is a polysaccharide drug preparation that inhibits galectin proteins. Recent phase 2b clinical trials have shown that this drug has cirrhosis in patients with nonalcoholic steatohepatitis (NASH) but no The population of esophageal varices produces a statistically significant and clinically relevant positive effect. Nonalcoholic steatohepatitis is a common liver disease unrelated to alcohol, characterized by accumulation of fat in the liver and inflammation and fibrosis. NASH can cause cirrhosis and liver function damage. According to NIH, the impact of NASH on American adults is about 6%, which is the fastest cause of liver transplantation and the cause of increased incidence of liver cancer.
The two patents acquired by GR-MD-02 in China provide extensive intellectual property protection. One of the patents covers methods of treating fibrosis, inflammation, and autoimmune diseases or cancer with GR-MD-02, which includes NASH, liver fibrosis, and immunotherapeutic uses of cancer. Another patent extends the use of GR-MD-02 to a variety of other diseases, including neurodegenerative diseases, psoriasis, skin and systemic lupus erythematosus, systemic sclerosis and dermatitis.
The company already has two patents in Japan, and the two newly acquired patents have given the company extensive intellectual property protection in the Japanese pharmaceutical market. The patent includes the use of NASH cirrhosis as the primary indication for GR-MD-02, as well as the ability to extend the scope of GR-MD-02 to be combined with a variety of cancer immunotherapies.
â–² Dr. Peter G. Traber, CEO, Chief Medical Officer and Patent Inventor of Galectin (Source: Galectin's official website)
“As the world's second largest and third largest pharmaceutical market, obtaining patent protection for GR-MD-02 in China and Japan is of great strategic importance to our company, especially in our NASH cirrhosis and cancer immunotherapy. In the case of clinical data, Dr. Peter G. Traber, CEO, Chief Medical Officer and Patent Inventor of Galectin, said: “We are considering bringing GR-MD-02 to the Asian market for the treatment of NASH cirrhosis and cancer immunity. These patents will provide us and future partners with opportunities for treatment and other diseases."
2. Portal vein hypertension non-invasive detection platform test data is gratifying
Exalenz Bioscience recently announced that clinical trials have shown that its BreathID platform can detect clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) in nonalcoholic steatohepatitis (NASH). In such patients, CSPH has been shown to be the most important independent predictor of several liver-related complications. The trial compared the use of the BreathID 13C-methacetin breath test (MBT) and invasive measurement of portal pressure. The results showed that MBT was highly sensitive and specific in this patient population.
CSPH is a serious chronic liver disease and cirrhosis complication characterized by elevated blood pressure from the gastrointestinal tract to the liver, which is closely associated with severe liver complications, morbidity and mortality. Current methods for detecting CSPH are invasive, complex to operate and highly dependent on the operator, and expose the patient to radiation and require injection of contrast material. Therefore, a non-invasive non-invasive test will bring great life improvement to these patients.
MBT is a simple, non-invasive method in which patients only need to drink half a cup of unscented solution, which is only metabolized in the liver. The patient's exhaled breath is then collected and measured by the BreathID system to measure the amount of specific breakdown products from the solution to reflect the rate of hepatic metabolism.
The two parallel clinical trials included 257 NASH patients with an average age of 59 years, a mean body mass index (BMI) of 34.6, and a CSPH prevalence of 62.3%. The preliminary model for the detection of CSPH using MBT was developed under the AUROC index of 0.88. MBT achieved 88% sensitivity and 85% specificity, as well as 10% uncertainty.
“Exalenz is committed to creating new breath tests for a variety of liver and gastrointestinal diseases using our proven BreathID platform,†said Raffi Werner, CEO of Exalenz. “We are very encouraged by the results of these two clinical trials. They demonstrate that MBT can effectively detect CSPH in NASH patients, which can provide clinicians with a new type of non-invasive tool to improve care for this patient population. We plan to push this new assay in 2020. To the market."
3. Arcturus Therapeutics and Wutian Pharmaceutical reached a cooperation
Arcturus Therapeutics recently announced the expansion of its partnership with Takeda Pharmaceutical. In collaboration, Takeda and Arcturus will use Arcturus' LUNARTM lipid-mediated delivery system and Unlocked Nucleomonomer Agent (UNA) technology to develop RNA-based therapeutics for the treatment of nonalcoholic steatohepatitis (NASH) and others. Gastrointestinal (GI) related diseases.
Founded in 2013, Arcturus Therapeutics, based in San Diego, California, is an RNA drug development company. Arcturus' versatile RNA therapy platform can be applied to many types of RNA drugs. Arcturus has LUNAR lipid-mediated delivery and UNA technology that can be used to target individual genes in the human genome, as well as viral genes and other targets for therapeutic purposes.
“This agreement with Takeda represents their continued commitment to our technology and development projects,†said Joseph Payne, President and CEO of Arcturus. “The partnership allows Arcturus to gain expertise in the field of RNA drugs. Complementing extensive clinical development experience in the GI field, we will work together to bring new treatments to NASH and other patients with gastrointestinal diseases."
4. New hepatitis B vaccine launches clinical trial in China
France's TRANSGENE SA recently announced that Phase 1 clinical trials to evaluate the use of T101 for the treatment of chronic hepatitis B virus (HBV) infection have begun, and the first patient has been treated in China. T101 is a viral vector that expresses the same HBV antigen suite as the TG1050 currently clinically developed in Europe and North America.
Hepatitis B is a liver disease that affects a wide range. 400 million people worldwide suffer from chronic hepatitis B, and more than 780,000 people die each year from hepatitis B complications. Currently available antiviral treatments can control chronic hepatitis B, but not cure the disease. Even under long-term treatment, patients are still likely to develop cirrhosis and liver cancer. China is a major hepatitis B infection country with at least 100 million chronic HBV infections in the country, and the incidence of hepatitis B continues to rise. In China alone, at least 500,000 patients may benefit from better treatment options.
T101 is an immunotherapeutic drug candidate for the treatment of chronic hepatitis B, which is based on the therapeutic vaccine TG1050. Preclinical studies have shown that TG1050 is capable of inducing active, extensive and long-lasting HBV-specific T cells, which are similar in characteristics to patients with healing. TG1050 also exhibits an antiviral effect. Recent clinical trial results have also shown good tolerance to the drug.
This phase 1 clinical trial was a randomized, single-center, double-blind, placebo-controlled study. The primary objective of this study was to verify the tolerability of T101 administered in single and multiple escalating doses. The trial will also assess the immunogenicity of therapeutic vaccines in different patient populations in Europe and North America. The trial will include 36 patients. The data is expected to be produced in early 2019.
Reference materials:
[1] Galectin Therapeutics Granted Patents in China and Japan that Support NASH and Cancer Immunotherapy Clinical Development Programs
[2] Exalenz Bioscience Announces Positive Clinical Trial Results For the Diagnosis of Clinically Significant Portal Hypertension in NASH Patients
[3] Arcturus Therapeutics Announces Expansion of Collaboration With Takeda Pharmaceuticals to Develop RNA-based Therapeutics for the Treatment of Nonalcoholic Steatohepatitis (NASH) and Other GI Disorders
[4] First Chronic Hepatitis B Patient Dosed in China in a Phase I Trial of T101 (Transgene's TG1050 Technology)
Original Title: Summary of Research Progress in the Field of Liver Diseases (No. 32)
2. Specifications:
|
Item |
Index |
|
Appearance |
Brown beige liquid |
|
Solid content |
30%±2 |
|
Viscosity |
≤30 |
|
pH |
3-5 |
|
Density |
1.02-1.1g/cm³ |
|
Ionic |
cationic |
|
Flash Point |
> 200℃Auto Ignition Temp |
4. Use Method:
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The consumption of the product depends on the quality of base paper, internal sizing and size resistance. It is usually 0.5-2.5% of oven dry weight.
5. Package and storage:
200KG or 1000KG plastic drums.
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