Rockaway, NJ, United States

Time filter

Source Type

The present invention relates to inventive novel industrialized method for preparing purified extract containing more abundant active ingredients such as catalpol derivatives from the extract of Pseudolysimachion rotundum var subintegrum than that prepared by the conventional preparation method disclosed in the prior art and the therapeutics or functional health food comprising the purified extract for treating and preventing inflammatory, allergic or asthmatic disease. The purified extract showed more potent anti-inflammatory, anti-allergy and anti-asthma activity than that prepared by the conventional preparation method disclosed in the prior art through various in vivo tests such as inhibition test on the reproduction of eosinophil, the release of immunoglobulin and inflammatory chemokines in plasma and bronchoalveolar fluid as well as the suppression of airway hyperresponsiveness and goblet cell hyperplasia in a OVA-sensitized/challenged mouse model.


News Article | February 23, 2017
Site: www.biosciencetechnology.com

Pain is tricky ailment to pin down.  First off there are many different types of pain — chronic pain, acute pain, nerve pain, joint pain, neuropathic pain and so on. Evaluating levels of pain within an individual and from person to person is difficult because it’s very subjective. What might rate as a level 3 in pain to one person could be an 8 to another, or a 3 might fluctuate for one person from day to day. Pain affects more Americans than diabetes, heart disease and cancer combined, according to the National Institutes of Health.  Chronic pain affects an estimated 25.3 million adults, and is the leading cause of long-term disability. Despite being significantly prevalent among U.S. adults, there is a gap in available pain treatments. Over-the-counter medications like NSAIDs and acetaminophen might not provide enough relief, while other options, such as opioids are effective at treating pain but come with a litany of side effects and potential consequences, as can be seen by the opioid epidemic in the U.S. A panel of industry executives came together Feb. 13 at the BIO CEO and Investor Conference in New York City, to discuss challenges in treating pain, and new alternatives in development that don’t have addictive side effects of traditional painkillers. “Despite advances in technology abuse deterrent hasn’t worked,” said moderator Corey Davis, managing director of H.C. Wainwright. “Believe it or not, heroin is cheaper than prescription medication to treat pain.” Although the opioid market is in decline, opioids are still the gold standard for treating moderate to severe pain and the market is still enormous, with over 250 million opioid prescriptions filled in the U.S. each year. “We’re very aware of some of the problems opioids have led to,” said panelist Gail Cawkwell, Chief Medical Officer of Purdue Pharma, the maker of OxyContin.  In an interview with Bioscience Technology Cawkwell said that the company is working to educate and set standards for prescribers to support appropriate use, and has separated out sales representatives’ compensation from the volume of OxyContin prescribed. The company is also diversifying into non-opioid analgesics, as well as other areas outside of pain. One of the treatments Cawkwell said she was most excited about is the ongoing development of a first –in-class TrkA inhibitor for the treatment of chronic pain.  TrkA is part of a larger family of signaling proteins, and the TrkA inhibitor works in many similar ways as nerve growth factor inhibitor biologics that several large pharma companies are developing.  Currently in Phase 2a development, the TrkA inhibitor is being tested in patients with osteoarthritis. Purdue hopes that by the end of the year they will have a good sense about the drug’s safety and efficacy, Cawkwell said. Another treatment in development is a potential first-in-class sigma-1 antagonist that could provide a new way to manage nerve-related pain, which Cawkwell said, is one of those challenging areas where there aren’t great solutions. Jeffrey Kindler, CEO of Centrexion Therapeutics, said since forming with the mission to develop non-addictive treatments for chronic pain, the company has developed a “robust pipeline” that includes injectables, small molecules, and topical treatments. Centrexion’s lead product, CNTX-4975 is a potent proprietary synthetic formulation that builds on the analgesic power of capsaicin, an active component of chili peppers. In a Phase 2b trial the injectable therapy met primary endpoints for osteoarthritis knee pain, with pain relief lasting six months following a single injection. Derek Chalmers, CEO of Cara Therapeutics, said opioids have been and continue to be very effective, however they have a poor side-effect profile and carry the risk of addiction.  His company is developing new therapies that selectively target the body’s peripheral kappa opioid receptors to treat acute pain, chronic pain, and pruritus (severe itching of the skin).  The lead product CR845 comes in both IV and oral form, and has shown pain-reliving properties in Phase 2 studies, without CNS-mediated side effects such as nausea, sedation, respiratory depression, addiction and euphoria. The therapy has also been studied in a human abuse liability study, which found CR845 is unlikely to be recreationally abused or lead to physical dependence. Russell Herndon, CEO of Hydra Biosciences is focused on peripherally active molecules for treatment of chronic and acute pain. The company has expertise in ion channel physiology and in particular a Transient Receptor Potential (TRP) channel blocker for treating painful diabetic neuropathy. Phase 1 studies have been completed, and the therapy works by reducing neural activity sending pain signals in to the brain without causing numbness, or a loss of physiological sensations. “There’s a huge need for alternative treatment for chronic pain,” Herndon said. “Millions of patients are suffering and need access to pain relief. It’s so expensive to develop new pain medication, so we’re hoping to find more investment to bring these non-addictive, next –generation therapies to market.” Cawkwell echoed these sentiments and told Bioscience Technology that one challenge to developing alternative pain medications is that “simply the lack of incentive in the environment right now.” Secondly, is that there is no test for the amount of pain. “I think the lack of good biomarkers for pain is a big deal,” Cawkwell said. The lack of validated biomarkers makes it hard for both the practice of medicine and also for developing drugs, she added. During the panel discussion Kindler noted that pain manifests in hundreds of different ways, and primary care physician may not be prepared to address all of the different diseases.  He also added that there are many challenges in terms of placebo effect and producing good clinical results. Herndon agreed and said that the subjective nature of people in clinical trials is one of the biggest challenges, but added there has been some progress. “We’re learning more and more what might be causing the pain to occur on a biological level, so we can capitalize by identifying what your drug is most likely to effect,” he said. Kindler echoed this, and said it’s exciting that the focus now is on finding new pathways to treat pain. Most of the panelists were encouraged by the conversation surrounding pain, and believe the area needs more resources and regulatory attention. As for the future of pain treatments Cawkwell said she hopes that in five years from now we’ll continue to see opioids available for the patients who truly need them, but being used less commonly and that many of the current gaps in available therapies will be filled by new drugs such as the ones Purdue Pharma is developing.


News Article | February 22, 2017
Site: www.biosciencetechnology.com

French biopharmaceutical company PharNext SA is taking a different approach to drug development, by identifying new indications for novel combinations of off-patent drugs at low doses. Xavier Paoli, chief commercial officer and vice president of R&D operations, said during an interview with Bioscience Technology at the BIO CEO and Investor Conference in New York City, that the company can cut five years off the drug development process using their new R&D paradigm called PLEOTHERAPY. PharNext was founded in 2007 by scientists and entrepreneurs including Daniel Cohen, M.D., Ph.D., a pioneer of modern genomics, who co-founded the Jean Dausset Foundation (formerly known as the Center for the Study of Human Polymorphism (CEPH)) in 1984, and helped generate the first physical map of the human genome in 1993. The drug discovery platform is based on genomic and other data that is analyzed to create what the company calls a complex biological disease network, which is essentially an inventory of potential therapeutic targets and drugs that might act on these targets. Focusing first on neurodegenerative diseases that have no therapeutic treatments, or where options are not optimal, the company has an ongoing Phase 3 trial for Charcot-Marie Tooth Disease Type1A and has completed a Phase 2a study for Alzheimer’s disease. While repositioning drugs is not new in the pharma industry, repositioning and combining drugs in a systematic way is, Paoli said. PharNext analyzes big data using statistical models, algorithms, and bioinformatics to pull all sorts of data – such as genomic, metabolic, and proteomic data – around one specific disease.  It takes about one year to build this complex molecular network of the disease, which then identifies which targets might have an effect with potential drugs. There are around 2,000 off-patent drugs that are available and once the disease network is developed it can be used, along with bioinformatics tools, to filter down to about 50 candidates, Paoli explained. Then those drugs are tested both alone and in combinations in vitro on specific cellular models of the disease for about one year. Results from the in vitro screenings usually further reduce the number of candidate drugs to about 25. From there the company identifies the best combination by lowering the dose and seeing which have a significant effect on a specific model.  Based on that the company can identify three to four combinations for a disease that are then tested in animals, which then leads to one combination that moves into clinical development. “So we select the combination based on several factors, the first one being the potential safety profile, but also the intellectual property that is available for these molecules,” Paoli said. Typical drug development takes around 15 years, according to Paoli, but with PharNext’s process the time can be cut down to 10 years, as seen with their most advanced drug PXT3003, which anticipates a read-out from its Phase 3 data in the second quarter of 2018. The company is able to save time in preclinical development as well as during clinical stages because sometimes they are not required to conduct Phase 1 studies since the safety profile is already known. Charcot-Marie-Tooth disease (CMT) is a group of rare, hereditary, degenerative nerve diseases that usually appears in teenage years or early adulthood.  The most common form of the disease is CMT type 1A (CMT1A), which is an orphan disease that affects at least 125,000 people in the U.S. and Europe. Patients experience muscle weakness, decreased muscle size and decreased sensation.  In CMT1A people have a duplication of the PMP22 gene, and overexpression of this gene causes demyelination of the axons on peripheral nerves, leading to nerve degeneration. Currently, there are no cures for the disease, and the most common treatment is physical and occupational therapy, as well as medications to reduce pain. Using the PLEOTHERAPY platform, the company identified three molecules that might be efficient in treating CMT1A: baclofen, naltrexone, and sorbitol.  The original indications included muscle spasticity in multiple sclerosis, opioid addiction and constipation. “So you can you see that [these indications] had nothing to do with CMT1A,” Paoli said. In preclinical work researchers were able to show that the PLEODRUG developed from these molecules, called PXT3003, was able to reduce overexpression of the PMP22 gene and improved CMT1A rat models on both clinical and non-clinical endpoints. Then came a Phase 2A study of 80 patients in France. The double-blind, randomized trial had four arms: a low dose, intermediate dose, high dose and placebo arm, with 20 patients in each. The oral liquid formulation was given twice daily, and patients were followed for 12 months. Eleven endpoints were tested, with one being a score on the Overall Neuropathy Limitations Scale (ONLS) which measures the disability of a patient, as well as the Charcot-Marie-Tooth Neuropathy Score (CMTNS), which is a measure of the level of the severity of the disease and patient impairment. Several functional measures were also tested, such as the six-minute walk test, and hand grip to measure the strength of the patient. Results showed a clear dose effect between the three dose levels, and in the high-dose arm there were three endpoints that were statistically significant and significantly improved versus the placebo, Paoli said.  One of these was the ONLS score, which is the primary endpoint that has been agreed upon by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the pivotal Phase 3 study. In the high-dose arm they observed an 18.6 percent improvement compared to the placebo, which is statistically significant.  Paoli said that if the company is able to show at least two-thirds of the improvement that has been seen in Phase 2 on this endpoint, that the Phase 3 trial would be considered positive In addition safety and tolerability results were positive, with zero difference between the placebo arm and therapy arms, Paoli said. Both the EMA and FDA granted Orphan Drug Status to the company’s rare disease drug. In December PharNext completed enrollment of 323 patients at 30 sites across the U.S., Canada, and Europe, with mild to moderate CMT1A. All enrolled patients have a diagnosis of the disease that’s been confirmed by genetic testing. The results of the pivotal, randomized, double-blind trial are expected next year.  Patients will either receive a placebo, the high dose of PXT3003 given in Phase 2, or a dose twice as high. A new target in the fight against Alzheimer’s disease PharNext’s Alzheimer’s disease drug, PXT864, has been tested in Phase 1 and Phase 2a clinical trials, and focuses on a new mechanism of action.  Unlike many drugs in the industry, this therapy does not target amyloid-beta or tau protein, buildup of which is known to be a hallmark of Alzheimer’s. “We think that at the origin of Alzheimer’s there is a disequilibrium in the patient brain between the excitatory and inhibitory pathway,” Paoli explained. The excitatory pathway would be too activated, and the inhibitory pathway would be too inhibited. Because of this disequilibrium, due to a metabolism issue, the brain enters a vicious cycle where it stimulates the overproduction of amyloid-beta and amyloid-beta stimulates the imbalance between the excitatory and inhibitory phase, according to Paoli.  PharNext’s mechanism of action is to act upstream of the amyloid-beta and tau protein. “The idea with our combination is to break this vicious cycle and to restore the balance between excitatory and inhibitory phase,” he said. In December the company presented positive exploratory Phase 2 Data from PXT864 at the 9th Clinical Trials on Alzheimer’s Disease (CTAD) Conference in San Diego.  The results suggest that the drug, which is an orally administered combination of baclofen and acamprosate, is well tolerated and safe for use in patients with Alzheimer’s. It also may slow the progression of cognitive disability, as shown by the primary endpoint of the study, the AD Assessment Scale Cognitive Subscale test. The company plans to conduct a Phase 2b study later this year to refine the dosing of the drug and to also test it in combination with the standard of care in Alzheimer’s which is donepezil. Other neurodegenerative diseases may have similar origins and Paoli said the company has good preclinical data in models of Parkinson’s and ALS, so they would like to move into Phase 2a studies for those conditions as well. If Phase 2a and Phase 2b trials produce strong results then the company would try to find a partner to perform Phase 3 studies. A third arm of the company’s business model is to have R&D collaboration with big pharma or other biotech companies that want to rescue a drug.  With their platform they can perform what is called reverse positioning, meaning that for a drug that failed in Phase 2 for example, because of a poor safety or efficacy profile, the technology can ‘rescue’ the drug either by identifying another indication or combining this molecule with other known drugs. While the company doesn’t currently have the financial means to investigate a number of diseases, the platform is universal, said Chief Financial Officer Pierre Schwich, so PharNext potentially has a very large portfolio of other diseases that could develop in the future.


News Article | February 28, 2017
Site: www.biosciencetechnology.com

Patients suffering from complete spinal cord injuries have little to no treatment options that provide meaningful improvement in patient outcomes. Cambridge, Mass.-based InVivo Therapeutics is trying to change that.  Co-founded in 2005 by MIT professor Robert Langer, and surgeon-scientists Joseph Vacanti, M.D., the company has developed a small, bioresorbable and biocompatible device called the Neuro-Spinal Scaffold, to help patients with complete thoracic spinal cord injuries regain some function. The highly porous device, smaller than the size of a quarter, is made up of Poly(lactic-co-glycolic acid) [PLGA], the same material as absorbable sutures, and two percent Ply-L-Lysine [PLL], which acts as a cellular adhesive, CEO Mark Perrin told Bioscience Technology during an interview at the BIO CEO and Investor Conference in New York City in February. The polymer scaffold eventually degrades over several weeks. A clinical trial involving 20 patients is currently underway, and initial results have been promising. Perrin explained that when spinal cord injury happens, there is tremendous force against the spine, which then pushes up against the cord and hemorrhaging and swelling begins inside the cord. Then a necrotic process, or premature cell death, takes places. Inside the spinal cord there is a butterfly shape made up of gray matter, and outside of that is white matter. White matter is very important because that’s where the axons, or what Perrin calls the ‘super highways’, go from the brain down to the lower extremities. Certain cell bodies inside the cord die very quickly and within 24 hours, liquefy, Perrin said. He showed a video in which doctor Nicholas Theodore from the Barrow Institute in Phoenix, implanted the Neuro-Spinal Scaffold into a patient.  The spinal cord is wrapped by dura, a protective tough leathery substance around the cord, which is tact back and then a slight incision is made. The video shows liquid necrotic material spill out, and a cavity is seen. “To see a little hole there was really quite remarkable,” Perrin said. Theodore uses intraoperative ultrasound to measure how big the cavity is inside the cord, and then the scaffold, which is one centimeter long but can also be trimmed, is gently inserted. Acting as a 3-D bandage of sorts, Perrin says what’s remarkable is the biological cascade that happens after implantation. “In the rat model, if you don’t do anything you this big, liquid-filled cyst with a scar and you get secondary damage as this gets bigger and pushes up against the white matter,” Perrin said. “But if you put a scaffold in, you reduce the size of this cyst, you get more white matter and you have this remodeled tissue.” The remodeled tissue is not just scar tissue, but is actually highly neuropermissive, Perrin said, and they found in animal models that there was a large amount of new neuronal growth. In addition, they observed regrowth of insulating myelin around the ends of the axons. All of the patients in the current INSPIRE study were implanted with the device within 96 hours post-injury and all have complete spinal cord injuries, so no motor, sensory or autonomic function below the point of injury. The critical endpoint of the study is if any motor sensory function is regained within six months of implantation.  Historically, conversion from complete paralysis to partial after spinal cord injury is about 15 percent Perrin said. In the current study, six out of 11, or about 55 percent, of patients made the conversion from complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. Perrin noted that the percentage could rise as two of those 11 patients are still within the six month follow-up period. The company hopes to complete enrollment of the other nine patients by the end of June so that they can have the last six-month data point of the final patient in December. The Food and Drug Administration has agreed that InVivo can submit their application on a rolling basis, which is a big plus Perrin said, as earlier modules, such as preclinical data can be reviewed and completed by the time the clinical portion is submitted. The main goal for 2017 is to complete the INSPIRE study, and then submit the Humanitarian Device Exemption application by the first quarter of next year, Perrin said. One thing Perrin stressed, was how vital it is to get treatment options to spinal cord injury patients. He pulled up a picture of the patient seen earlier in the implantation video, walking with braces. While the patient must wear braces and use a walker, the company is being told that he can walk about a quarter mile a day now. The patient went from first feeling his hips, to now feeling ankle contractions. “This says it all,” Perrin said. “That’s why we’re in business and that’s the most important thing is if we can help these patients who up until now have had absolutely nothing.”


The present invention relates to novel pterocarpan compound or pharmaceutically acceptable salt thereof and a composition for the prevention or treatment of metabolic disease or complications thereof comprising the same as an active ingredient. The novel pterocarpan compound of the present invention isolated from soybean leaves inhibits -glucosidase activity and hACAT activity, and suppresses LDL-oxidation efficiently. Therefore, the compound of the present invention not only can be effectively used for the prevention or treatment of metabolic disease or complications thereof but also can be effectively used as an anti-oxidative composition owing to its excellent anti-oxidative activity.


Patent
Bioscience Technology | Date: 2013-09-16

Provided are a complex microbial flora, an application thereof in preparing a textile fabric, a cellulose for use as an additive, and a biological bacterial solution pulp, and a method for using the complex microbial flora. The complex microbial flora comprises Bacillus sp. of deposit number CGMCC No. 5971, Rheinheimera tangshanensis of deposit number CGMCC No. 5972, Acinetobacter Iwoffi of deposit number CGMCC No. 5973, Pseudomonas fluorescens of deposit number CGMCC No. 5974, and Wickerhamomyces anomalus of deposit number CGMCC No. 5975. The method provided comprises: formulation of a bacterial solution, processing of raw materials, and preparation or pulping of the fiber. In one embodiment, the invention generally includes at least one Bacillus. Sp. under CGMCC Deposit No. 5971 alone or in the presence of other microorganisms as a complex microbial flora, and their applications thereof.


Patent
Bioscience Technology | Date: 2013-09-16

Provided are a complex microbial flora, an application thereof in preparing a textile fabric, a cellulose for use as an additive, and a biological bacterial solution pulp, and a method for using the complex microbial flora. The complex microbial flora comprises Bacillus sp. of deposit number CGMCC No. 5971, Rheinheimera tangshanensis of deposit number CGMCC No. 5972, Acinetobacter Iwoffii of deposit number CGMCC No. 5973, Pseudomonas fluorescens of deposit number CGMCC No. 5974, and Wickerhamomyces anomalus of deposit number CGMCC No. 5975. The method provided comprises: formulation of a bacterial solution, processing of raw materials, and preparation or pulping of the fiber. In one embodiment, the invention generally includes at least one Wickerhamomyces anomalus of deposit number CGMCC No. 5975, either alone or in the presence of other microorganisms as a complex microbial flora, and their applications thereof.


Patent
Bioscience Technology | Date: 2013-09-16

Provided are a complex microbial flora, an application thereof in preparing a textile fabric, a cellulose for use as an additive, and a biological bacterial solution pulp, and a method for using the complex microbial flora. The complex microbial flora comprises Bacillus sp. of deposit number CGMCC No. 5971, Rheinheimera tangshanensis of deposit number CGMCC No. 5972, Acinetobacter lwoffii of deposit number CGMCC No. 5973, Pseudomonas fluorescens of deposit number CGMCC No. 5974, and Wickerhamomyces anomalus of deposit number CGMCC No. 5975. The method provided comprises: formulation of a bacterial solution, processing of raw materials, and preparation or pulping of the fiber. In one embodiment, the invention generally includes at least one Pseudomonas fluorescens of deposit number CGMCC No. 5974, either alone or in the presence of other microorganisms as a complex microbial flora, and their applications thereof.


Patent
Bioscience Technology | Date: 2013-09-16

Provided are a complex microbial flora, an application thereof in preparing a textile fabric, a cellulose for use as an additive, and a biological bacterial solution pulp, and a method for using the complex microbial flora. The complex microbial flora comprises Bacillus sp. of deposit number CGMCC No. 5971, Rheinheimera tangshanensis of deposit number CGMCC No. 5972, Acinetobacter lwoffii of deposit number CGMCC No. 5973, Pseudomonas fluorescens of deposit number CGMCC No. 5974, and Wickerhamomyces anomalus of deposit number CGMCC No. 5975. The method provided comprises: formulation of a bacterial solution, processing of raw materials, and preparation or pulping of the fiber. In one embodiment, the invention generally includes at least one Rheinheimera tangshanensis of deposit number CGMCC No. 5972, either alone or in the presence of other microorganisms as a complex microbial flora, and their applications thereof.


Patent
Bioscience Technology | Date: 2013-09-16

Provided are a complex microbial flora, an application thereof in preparing a textile fabric, a cellulose for use as an additive, and a biological bacterial solution pulp, and a method for using the complex microbial flora. The complex microbial flora comprises Bacillus sp. of deposit number CGMCC No. 5971, Rheinheimera tangshanensis of deposit number CGMCC No. 5972, Acinetobacter lwoffii of deposit number CGMCC No. 5973, Pseudomonas fluorescens of deposit number CGMCC No. 5974, and Wickerhamomyces anomalus of deposit number CGMCC No. 5975. The method provided comprises: formulation of a bacterial solution, processing of raw materials, and preparation or pulping of the fiber. In one embodiment, the invention generally includes at least one Acinetobacter lwoffii of deposit number CGMCC No. 5973, either alone or in the presence of other microorganisms as a complex microbial flora, and their applications thereof.

Loading Bioscience Technology collaborators
Loading Bioscience Technology collaborators