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Patent
HCC Inc. | Date: 2016-08-30

A cam follower design wherein a cam track is provided proximate one or both ends of a harvester pick-up reel. Cam followers travel along the cam track as the pick-up reel rotates to move crop into the harvester. At least one roller of each cam follower engages and rolls along an interior edge surface of the cam track, and at least one other roller of each cam follower engages and rolls along an exterior edge surface of the cam track. The rollers are preferably engaged with a carrier member which is linked to a corresponding bat tube. Each cam follower preferably also includes at least one over center stop which is configured to maintain the intended radial position of the bat tube.


Patent
Hcc Inc. | Date: 2016-06-28

A tool or extractor which is lightweight and portable. The tool includes a plate which is mountable to a mini-skid steer loader. The tool includes a first jaw member which is fixed. The first jaw member is preferably welded or otherwise attached to or engaged with the plate. The tool also includes a second jaw member. The second jaw member is moveable, such as via a hydraulic cylinder, and is pivotably connected the plate. The hydraulic cylinder is also preferably pivotably connected to the plate, and is controlled in order to affect a grip on a thing to be extracted. The mini-skid steer loader is then operable to pull up on the thing, and extract the thing from the ground.


A non-split bearing design for use with a harvester pick-up reel. In one specific embodiment, the outer member directly engages the inner member. In another embodiment, the bearing is provided as being an interchangeable roller bearing, and in that case there is preferably an intermediate member which is disposed between the outer member and the inner member. Regardless, providing that the bearing is non-split provides that the design is simplified, as well as provides that the inner bore, i.e., the bore which engages the bat tube, can be more easily controlled, thereby reducing or even eliminating service requirements.


The FDA submission is based on the positive results of the pivotal Phase 3 REFLECT trial. In this study, lenvatinib was the first systemic therapy to show non-inferior overall survival (OS) versus sorafenib in previously untreated patients with unresectable HCC and demonstrated statistically significant and clinically meaningful improvements in all three secondary efficacy endpoints – progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR). "The liver cancer community has been long awaiting additional first-line treatment options for this advanced form of the disease, and today's file submissions are an important next step to potentially being able to offer patients and doctors another option," said Kenichi Nomoto, Chief Scientific Officer, Oncology Business Group, Eisai. "Based on the activity observed in the REFLECT trial, Eisai is eager to work with the U.S. FDA and regulatory agencies worldwide with the hope of quickly bringing lenvatinib to patients with liver cancer." The REFLECT study results were presented in an oral session at this year's American Society of Clinical Oncology (ASCO) Annual Meeting and will be published in a peer-reviewed journal later this year. This release discusses an investigational use for an FDA-approved product. It is not intended to convey conclusions about safety or efficacy. There is no guarantee that any investigational uses of such FDA-approved product will gain FDA approval. About the REFLECT Trial (Study 304) REFLECT was an international, multicenter, open-label, randomized, non-inferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in patients with unresectable HCC. Patients (n=954) at 183 trial sites in 21 countries were randomized to receive lenvatinib 12 mg or 8 mg once a day depending on body weight (≥60 kg or <60 kg) (n=478) or sorafenib 400 mg twice a day (n=476). Treatment was continued until disease progression or unacceptable toxicity. The primary endpoint of this study was overall survival. The secondary efficacy endpoints of this study were progression-free survival, time to progression and objective response rate. The median OS for patients treated with lenvatinib was 13.6 months compared to 12.3 months for sorafenib (HR: 0.92; 95% CI: 0.79 – 1.06). Median PFS was 7.4 months with lenvatinib with a median TTP of 8.9 months compared to median PFS of 3.7 months (HR: 0.66; 95% CI: 0.57 – 0.77; p<0.00001) and median TTP of 3.7 months on sorafenib (HR 0.63; 95% CI; 0.53 – 0.73; p<0.00001). In addition, lenvatinib demonstrated significantly higher ORR (24%) compared to sorafenib (9%) (odds ratio: 3.13; 95% CI: 2.15-4.56; p<0.00001). Endpoints were evaluated using mRECIST and determined by investigator assessment. Independent radiologic review is now complete and the results will be shared with the medical community in an upcoming publication and/or congress. In this study, the most common treatment-emergent adverse events (TEAEs) observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, decreased weight, and fatigue. In the sorafenib arm, the most common TEAEs were palmar-plantar erythrodysesthesia, diarrhea, hypertension, and decreased appetite. Patients who received lenvatinib had fewer instances of palmar-plantar erythrodysesthesia, diarrhea and alopecia, and more instances of hypertension, proteinuria, dysphonia, and hypothyroidism, than did patients who received sorafenib. Nine percent of patients treated with lenvatinib and 7% of patients treated with sorafenib discontinued treatment due to treatment-related adverse events. Forty-three percent of patients treated with lenvatinib and 30% of patients who received sorafenib experienced serious TEAEs. About Hepatocellular Carcinoma (HCC) Hepatocellular carcinoma is the most common type of liver cancer, accounting for about 90% of cases of primary liver cancer in the United States. In 2015, liver cancer accounted for approximately 788,000 deaths globally, making it the second leading cause of cancer-related deaths worldwide. The prevalence and mortality rate of liver cancer has been rising steadily over the past decade. This year in the United States, more than 40,710 cases will be diagnosed and 28,920 people will die from their disease. HCC patients with advanced stage disease may not be amenable for potentially curative therapeutic interventions such as a liver transplant, surgical resection or tumor ablation (typically radiofrequency ablation). Patients who cannot be treated with potentially curative approaches have a poor prognosis. About LENVIMA® (lenvatinib) LENVIMA® (lenvatinib) is a kinase inhibitor that is indicated for: Lenvatinib, discovered and developed by Eisai, is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1-3. Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. For more information about LENVIMA, click here for the full Prescribing Information. About Eisai Inc. At Eisai Inc., human health care (hhc) is our goal. We give our first thought to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs. Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.


BROOKWOOD, Ala.--(BUSINESS WIRE)--Warrior Met Coal (NYSE: HCC) today announced that it will hold its second quarter 2017 investor conference call at 4:30 p.m. ET on Thursday, August 3, 2017. Warrior Met Coal will release its results following the close of market trading that afternoon. To participate in the conference call, please call 1-866-807-9684 (domestic) or 1-412-317-5415 (international) 10 minutes prior to the start time and reference the Warrior Met Coal conference call. A webcast of the conference call will be available through the Investor section of the Warrior Met Coal website, http://investors.warriormetcoal.com, where an archived replay will also be available. Telephone playback will also be available beginning at 7:30 p.m. ET on August 3, 2017 until 7:30 p.m. ET on September 5, 2017. The replay will be available by calling: 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and entering passcode 10109914. Warrior Met Coal is a large-scale, low-cost U.S. based producer and exporter of premium hard coking coal (“HCC”) operating highly efficient longwall operations in its underground mines located in Alabama. The HCC that Warrior produces from the Blue Creek coal seam contains very low sulfur and has strong coking properties, and is of a similar quality to coal referred to as the benchmark HCC produced in Australia. The premium nature of Warrior’s HCC makes it ideally suited as a base feed coal for steel makers and results in price realization near the HCC benchmark. Warrior sells all of its met coal production to steel producers in Europe, South America and Asia. For more information about Warrior Met Coal, please visit www.warriormetcoal.com.


LONDON--(BUSINESS WIRE)--Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, today announces the enrolment of the first patient in its phase IIa clinical trial with milciclib, a novel inhibitor of cyclin-dependent kinases (CDKs), in patients with refractory hepatocellular carcinoma (“HCC”). Top line data from this trial, being conducted in Italy, Israel, Greece and Turkey, is expected in Q4 2018. The primary objective of this multi-centre, multi-country and dose-ranging phase IIa clinical study is to evaluate the safety of milciclib in HCC patients who fail to respond to or are intolerant to the existing standard of care treatment. Subsequently, a phase IIb is planned with the combination of milciclib with the standard of care treatment sorafenib in HCC patients. Milciclib is an inhibitor of several cyclin-dependent kinases (CDKs), which are commonly overexpressed in tumours resistant to chemotherapy. Accordingly, the investigational therapy will be tested in patients who have failed to respond to the standard of care treatment, sorafenib (Nexavar®). Preclinical studies conducted strongly suggest that milciclib acts primarily through downregulation of microRNA (miR) 221 and 222, which are known to be associated with hepatocarcinogenesis and overexpression of these miRs is also believed to be associated with development of resistance to sorafenib in HCC patients. In previous phase I clinical studies, oral treatment with milciclib was found to be safe and well-tolerated in patients with advanced solid tumours such as thymoma and thymic carcinoma, pancreatic carcinoma and colon cancer.1 The combination of milciclib with gemcitabine, a well-known nucleoside analogue, in a phase I dose-escalation study showed favourable clinical responses in approximately 36% of patients with advanced/metastatic tumours, including patients previously considered to be resistant to gemcitabine.2 Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented: "HCC is a real unmet medical need due to its growing incidence and lack of effective therapy. It is the fifth most common cancer worldwide and the second most common cause of death from cancer worldwide.” Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences, commented: “Oral treatment with milciclib has been well-tolerated in previous studies with cancer patients. We strongly believe, based on its unique mechanism of action, that the drug may have potential to be developed either as a monotherapy or combo-therapy with sorafenib for treatment of HCC.” Dr. Ilan Yaron, Director of the Department of Medicine at Hebrew University Hadassah Medical Center, Israel and Chief Medical Officer of Tiziana Life Sciences, added: “The prognosis for liver cancer is very poor due to lack of effective therapy. We believe that milciclib holds promise as an effective anti-cancer treatment with a high safety profile." Hepatocellular carcinoma is the fifth most common cancer in men and the ninth in women. Additionally, it is the fifth most common cancer worldwide and the second most common cause of death from cancer worldwide.3 The tumour is associated with chronic hepatitis B and chronic hepatitis C infections, as well as with nonalcoholic steatohepatitis. The prognosis for liver cancer is very poor due to lack of effective therapy. Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases (CDKs) such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. Oral treatment with milciclib was found to be effective in reducing tumour growth in animal models of HCC, possibly through downregulation of miR-221 and miR-222. In a phase I study, oral treatment with milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in thymic carcinoma, pancreatic carcinoma and colon cancer. Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules that treat human disease in oncology and immunology. The Company is focused on its lead compound milciclib. The Company is also in clinical development of foralumab. Foralumab is the only fully human engineered anti-human CD3 antibody in clinical development. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. 1. Weiss GJ, Hidalgo M, Borad MJ, et al. (2012) Phase I study of the safety, tolerability and pharmacokinetics of PHA-848125AC, a dual tropomyosin receptor kinase A and cyclin-dependent kinase inhibitor, in patients with advanced solid malignancies. Invest New Drugs 30:2334-43. doi: 10.1007/s10637-011-9774-6. 2. Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. Cancer Chemother Pharmacol (2017). Phase I dose-escalation study of milciclib in combination with gemcitabine in patients with refractory solid tumors. Cancer Chemother Pharmacol. 79:1257-1265. 3. Sahil Mittal and Hashem B. El-Serag (2013) Epidemiology of HCC: Consider the Population. J Clin Gastroenterol. 2013 Jul; 47(0): S2–S6. For more information go to http://www.tizianalifesciences.com This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.


A hydraulic system for driving a post driver of a skid steer loader. The hydraulic system includes a master cylinder disposed between a valve, such as a 4-way valve, and the driver cylinder of the post driver. The master cylinder effectively provides that hydraulic fluid from the 4-way valve to the hydraulic system of the skid steer loader can flow freely without needing an auxiliary pump and motor to overcome resistance in the return line back to the skid steer loader hydraulic system. By eliminating the restriction in the return line of the driver cylinder, a very fast retraction can be achieved, improving the impact performance of the system.


A tine for use with a harvester. The tine is preferably an injection molded polymer pickup reel tine, which uses a front-to-rear mold parting line direction. The tine preferably has a snap ring or strap portion which is configured to engage a bat tube, as well as a finger portion which is configured to engage the crop during harvesting. Preferably, the front-to-rear parting line is along both portions. The front-to-rear parting line allows for the ability to provide a deep front-to-rear cross section for rigidity at the high stress area of the tine. Two front-to-rear material saving features can be utilized to minimize material usage and allow for relative consistent wall thickness, which results in a rigid cross section that maintains deflection stability in the normal direction of deflection. The preferred form of the tine cross section includes three deep oval sections or projections, connected by two oval depressions, but other variations are entirely possible while still resulting in effectively the same benefits.


Patent
HCC Inc. | Date: 2015-11-03

A roller frame assembly for a pick-up reel of a harvester, where the roller frame assembly is adjustable in that its position can be easily adjusted relative to a position of a drive shaft of the pick-up reel, thereby effectively converting the pick-up reel from a flip reel to a non-flip reel, and vice versa.


A bat tube for use with a harvester pick-up reel. The bat tube is configured to resist torsional loads, without having to use fasteners that engage holes in the bat tube. Preferably, the external surface of the bat tube provides at least one key or keyway that engages a corresponding keyway or key in the band or strap portion of the tines. As such, once a tine is engaged with the bat tube, the tine is generally prevented from rotating about the bat tube. Additionally, by not using fasteners to engage holes in the bat tube, spacing between the tines can be varied. The bat tube allows for tine fastening and torsional resistance without drilling or punching holes, which allows for easily variable tine spacings. It also allows for improved crop gathering and crop entry characteristics over a typical round profile.

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