Hepcidin antagonist, Pipeline Analysis, 2017

The hepcidin antagonist pipeline has more than 10 drugs. In pipeline analysis, drugs are analyzed on the basis of route of administration and molecule type. The pipeline is also analyzed on the basis of monotherapy and combination therapy, and different clinical phases including Phase III, Phase II, Phase I and Pre-clinical stage.

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Phase III

Phase III clinical trial known for the comparison of new treatments with the standard treatment in which the safety, efficacy and side effects of new intervention is compared with the already existing treatment. The Phase III clinical trial takes around 2-3 years to complete and the total number of participants vary from 100-1,000. In Hepcidin antagonist, there are 3 drugs in phase III clinical trial. For instance, Luspatercept, a phase III drug candidate of Celgene Corporation is being developed in collaboration with Acceleron Pharma, Inc., for the treatment of anemia with myelodysplastic syndromes and anemia associated with beta thalassaemia.

Phase II

NOX-H94 is a phase II drug candidate of NOXXON Pharma N.V. The drug candidate is an anti-hepcidin single-stranded structured L-RNA oligonucleotide conjugated to 40kDa polyethylene glycol. Phase II clinical trial is the second phase that answer safety, efficacy and dosing of the new intervention. It takes around 2 years to complete and between 100 – 120 patients participate in the Phase II trial.

Phase I

PRS 080, a phase I/II drug candidate is under development by Pieris Pharmaceuticals, Inc. for the treatment of anemia. The drug candidate is an hepcidin antagonist, which can restore iron utilization and erythropoiesis.  The company mentioned that the compound has successfully shown a favorable safety profile in healthy volunteers and is expected to complete a multi-dose trial by mid of 2017. In Phase I clinical trial, safety of the new intervention is determined. The trial takes around 1-2 years to complete and the total number of volunteers participating in the trial vary between 15 – 30.

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Pre-Clinical

Pipeline analysis provides description about the key companies developing hepcidin antagonist drugs. Some of the key players actively involved in the research and development are Celgene Corporation, Akebia Therapeutics, Inc., FibroGen, Inc., Noxxon Pharma AG and Tolero Pharmaceuticals, Inc.

Janus Kinase Inhibitors Pipeline Analysis – Designation, Collaboration and Developments

Janus kinase (JAK) inhibitors block Janus kinase activator enzymes and interrupt signaling pathway. It plays an important role in host defense, oncology, autoimmunity and hematological cancers, which makes them an important target for therapeutics. Many signal transduction pathways are done by JAK activity for the normal signaling. The abnormal aberration in JAKs activity can lead to diseased state. For instance, over activation of JAK can lead to tumorigenesis whereas loss of JAK can lead to severe combined immunodeficiency. Janus Kinases family contains JAK 1, JAK 2, JAK 3 and a group of cytoplasmic non-receptor Tyrosine kinases (NRTKs).

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The cytokine receptor is associated with JAKs present on the surface of cells. JAK tyrosine kinase family are primarily associated with signal transduction originating from extracellular ligands, which often interact with transmembrane receptors. Different JAK tyrosine kinase are the key components in mediating signaling process such as expression of genes involved in proliferation, apoptosis, migration, and differentiation. They play a major role in immune defense as many signaling events involved in both innate and adaptive immunity is mediated by JAKs. They are also involved in cell growth, survival, development, and differentiation of immune cells. Mutation in JAKs leads to the immunodeficiency disorders.

Aclaris Therapeutics, Inc. is developing ATI-50001, a pre-clinical drug candidate for the treatment of alopecia universalis and alopecia totalis. Pre-clinical study is also known as animal study. It is done before testing a drug in people to find out the toxicity profile of the drug. Pre-Clinical study is of two types, including In vitro and In vivo.

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Pipeline analysis provides description about the key companies developing JAK inhibitor drugs. Some of the key players actively involved in the research and development are Galapagos NV, AbbVie Inc., Eli Lilly and Company, Gilead Sciences, Inc., Astellas Pharma Inc., CTI BioPharma Corp., Portola Pharmaceuticals, Inc., Japan Tobacco International, Incyte Corporation, Pfizer, Inc., and Asana BioSciences, LLC.

Hodgkin’s Lymphoma Therapeutics Pipeline Analysis 2017

Hodgkin_s Lymphoma Therapeutics Pipeline

The Hodgkin’s lymphoma therapeutics pipeline is expected to witness considerable growth in the coming years as the researchers are making novel drug delivery system for the treatment for cancer. The government agencies such as National Cancer Institute and American Cancer Society are supporting the growth of the Hodgkin’s lymphoma (HL) therapeutics pipeline by providing funding, designations and grants for speeding up the drug development process. High prevalence of cancer, increasing awareness regarding cancer treatment, technological advancements and high demand for safe and effective medication are driving the growth of the Hodgkin’s Lymphoma therapeutics pipeline.

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Hodgkin lymphoma (HL) or Hodgkin’s disease is an uncommon cancer of the lymphatic system, such as lymph nodes. The lymphatic system is made up of a network of vessels and glands that spread throughout the body. The vessels of lymphatic system known as lymphocytes carrying clear fluid known as lymph, contains lymphocytes (white blood cells that help combat infection). The lymphatic is a part of the human body’s immune system. In Hodgkin’s lymphoma, the patient experiences a painless swelling in a lymph node, usually in the neck, armpit or groin.

Pharmaceutical companies, such as Mirati Therapeutics, Inc., are developing Mocetinostat in combination with Brentuximab Vedotin in Phase I/II stage for Hodgkin’s lymphoma. Mocetinostat is an orally bioavailable and spectrum-selective Histone Deacetylase (HDAC) inhibitors. The drug candidate is believed to reverse aberrant acetylation resulting from histone acetyltransferase (HAT) mutations, thereby prohibiting tumor progression and reducing tumor burden in patients.

According to the National Cancer Institute, a part of the U.S. National Institutes of Health, an estimated 8,500 new cases and 1,120 deaths were reported in the U.S., in 2016, due to Hodgkin’s lymphoma.

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Some of the companies having a pipeline of Hodgkin’s lymphoma therapeutics include Bristol-Myers Squibb Co., Merck & Co. Inc., Pfizer, Inc., F. Hoffmann-La Roche Ltd., Novartis AG, Affimed Therapeutics AG, Aeterna Zentaris Inc., Incyte Corporation, and 4SC AG.

Multiple Myeloma Therapeutics Pipeline – Patent, Collaboration and Other Developments

Multiple Myeloma (MM) Therapeutics Pipeline

The multiple myeloma therapeutics pipeline is expected to witness considerable growth in the coming year due to high prevalence of the disease. The growth of multiple myeloma therapeutics pipeline is assisted by targeted therapy and new effective treatment. Also, increased awareness among the population about the various cancer treatments has further fueled the growth of the therapeutics pipeline. Increasing healthcare expenditure and technological advancements are supporting the growth of the therapeutics pipeline for multiple myeloma. An increasing demand for safe and effective medications is also driving the growth of the multiple myeloma therapeutics pipeline. Many government initiatives such as increased funding, designations and grants for speeding up the drug development process has also supported the growth of the therapeutics pipeline.

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The National Cancer Institute, which is a part of the U.S. National Institutes of Health, defines multiple myeloma as a cancer that is formed by malignant plasma cells. Normal plasma cells are found in the bone marrow as an important part of the immune system. The immune system is made up of several types of cells that work together to fight infections and other diseases. Lymphocytes (lymph cells) are the main cell types of the human immune system and the major types of lymphocytes are T cells and B cells. When B cells respond to an infection, they mature and change into plasma cells. Plasma cells make the antibodies (also known as immunoglobulins) that help the body attack and kill germs. Lymphocytes are present in many areas of the body, such as lymph nodes, bone marrow, intestines, and the bloodstream. Plasma cells, however, are mainly found in the bone marrow. Bone marrow is the soft tissue found inside some hollow bones. In addition to plasma cells, the bone marrow has those cells that make the different normal blood cells.

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Some of the companies having a pipeline of myeloma therapeutics include Celgene Corporation, Bristol-Myers Squibb, Abbvie, Inc., Novartis AG, F. Hoffman La Roche AG, Amgen, Inc., Karyopharm Therapeutics, Inc., Array BioPharma, and Takeda Pharmaceutical Company Limited.

Thyroid Cancer Therapeutics Pipeline – Clinical Trials & Results, Patent and Developments

Thyroid Cancer Therapeutics Pipeline

The thyroid cancer therapeutics pipeline is expected to witness considerable growth due to increase in the demand for the targeted drug formulation for the treatment of cancer. Though less number of drugs are available for thyroid cancer treatment, an increasing awareness regarding cancer treatment and high demand for safe and effective medications are driving the therapeutics pipeline.

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According to the National Cancer Institute, a part of the U.S. National Institutes of Health, thyroid cancer is a rare type of cancer that affects the thyroid gland, a small gland at the base of the neck that produces hormones. It most commonly occurs in people aged 30-year-old. Women are two to three times more likely to develop this thyroid cancer, as compared to men. Thyroid cancer is usually treatable, and in many cases, can be cured completely, although it can sometimes come back after treatment. There are four main types of thyroid cancer; papillary thyroid cancer, follicular thyroid cancer (hurthle cell thyroid cancer), medullary thyroid cancer and anaplastic thyroid cancer.

Among the presently available drugs, Lenvatinib, a small molecule drug candidate of Eisai Co Ltd., was approved by USFDA on 13 February 2015. It is an orally active multi-targeted kinase inhibitor, which inhibits vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptors and other tyrosine kinases.

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Many pharmaceutical companies are focusing on the research and development of thyroid cancer therapeutics pipeline drug candidates, collaborating with one another. In February 2015, Biologics, Inc., an integrated oncology services company, reported that it was selected by Eisai Co. Ltd. as a specialty pharmacy provider within Eisai’s limited distribution network for Lenvima (lenvatinib).

Some of the key players having a pipeline of thyroid cancer therapeutics include Eisai & Co. Ltd., Exelixis, Amgen, AstraZeneca plc, Merck & Co., Inc., Daiichi Sankyo Company Limited, and F. Hoffmann-La Roche AG.

Amyotrophic Lateral Sclerosis Pipeline – Designation, Collaboration, and Other Developments

Amyotrophic Lateral SclerosisThe study analysed that the Amyotrophic lateral sclerosis pipeline comprises of 72 drug candidates in different stages of development.

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Amyotrophic lateral sclerosis is a disease that causes progression in neurodegeneration in brain and spinal cord. In Amyotrophic lateral sclerosis, the muscle does not get adequate nourishment due to which it becomes atrophic. The disease occurs in the lateral region, an area in which spinal cord reflexes are found majorly. Therefore, the degeneration leads to hardening and scarring of muscles in that region. The progressive degeneration of neurons from brain to the spinal cord and spinal cord to the whole body can ultimately lead to their death. Amyotrophic lateral sclerosis is classified into two types, namely, sporadic and familial. Approximately 90% to 95% of the patients suffering from the disease in the U.S. are experience the sporadic.

According to the route of administration analysis, most of the drug candidates are being developed to be administered by oral route.

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NurOwn is a cell therapy platform that builds on the enormous research effort that has gone into developing mesenchymal stem cells (MSCs) as a treatment for human diseases.

Some of the key players developing drugs for Amyotrophic lateral sclerosis include FlexPharma, Inc., Orion Corporation, Genervon Biopharmaceuticals, LLC, and others.

Acute Respiratory Distress Syndrome Therapeutics Pipeline – Designation, Collaboration, and Other Developments

The acute respiratory distress syndrome therapeutics pipeline is expected to witness nominal growth in the coming year due to the slow research and development activities of the pipeline drugs. Some of the factors driving the growth of the pipeline include approval of new therapies that include but are not limited to, tissue factor antagonists, cluster of differentiation modulators, p38 kinase inhibitors and DNA polymerase inhibitors. Also, increasing awareness regarding the acute respiratory distress syndrome treatment, high demand for safe and effective medications and technological advancements are also supporting the growth of the acute respiratory distress syndrome therapeutics pipeline.

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According to American Lung Association, acute respiratory distress syndrome is a rapidly progressive disease occurring in critically ill patients. The main complication in acute respiratory distress syndrome is the leakage of fluid into the lungs that leads to difficulty in breathing. Acute respiratory distress syndrome, is a buildup of fluid in the tiny air sacs in the lungs called alveoli, resulting in less oxygen to the organs, which is very dangerous. Acute respiratory distress syndrome occurs when there is significant trauma that either affects the lungs directly or indirectly. Some of the traumas associated with the disease are sepsis (a blood infection), severe pneumonia, major trauma and shock from any cause. The body responds to this trauma with an inflammatory reaction that releases numerous natural molecules into the bloodstream. Normally, this inflammatory reaction would be protective and helps in fighting infections or healing of injuries. However, in some people, these inflammatory molecules are responsible for the leakage of fluid from the small blood vessels into lungs. Fluid leaves these small vessels and goes into the alveoli. The alveoli filled with this fluid, makes obstruction difficult for oxygen to get into the bloodstream.

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Some of the companies having a pipeline of acute respiratory distress syndrome therapeutics include GlaxoSmithKline plc, Altor BioScience Corporation, Pfizer, Inc., BioLineRx, AbbVie, Inc., Amgen, Alliance Pharmaceutical Corporation, Daiichi Sankyo Co., Ltd. and Faron Pharmaceuticals Ltd.

Venous Thromboembolism Therapeutics Pipeline Analysis – Collaboration, and Other Developments

Venous Thromboembolism Therapeutics Pipeline

The venous thromboembolism therapeutics pipeline is expected to witness considerable growth in the coming year due to the development of novel oral anticoagulants as a reasonable and established treatment option. The regulatory bodies are supporting the drug development process through different types of designations and funding. The pipeline is being driven by different factors such as increasing awareness regarding the venous thromboembolism therapeutics pipeline, high demand for safe, effective and affordable medications, technological advancements and increasing prevalence of the venous thromboembolism.

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According to American Heart Association, Venous thromboembolism (VTE) collectively develops as a combination of deep vein thrombosis (DVT) and pulmonary embolism (PE), two life-threatening conditions. Venous thromboembolism is a common and preventable disease in which the clot formation occurs in the vein associated with Venous thromboembolism. In deep vein thrombosis, a clot formed in a deep vein, usually in the leg. Pulmonary embolism is a deep vein thrombosis clot that breaks free from a vein wall, travels to the lungs and blocks some or all of the blood supply. Blood clots in the thigh are more likely to break off and travel to the lungs than the clots in lower leg or other parts of the body.

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Some of the companies having a pipeline of venous thromboembolism therapeutics include Bristol-Myers Squibb Company, Pfizer, Inc., Sanofi-Aventis, Daiichi Sankyo Co. Ltd., Astellas Pharma Inc. and Johnson & Johnson.

Neuroblastoma Therapeutics Pipeline Analysis 2017 – Collaboration and Other Developments

Neuroblastoma

The neuroblastoma therapeutics pipeline is expected to witness considerable growth in the future due to high prevalence of tumour in children. According to the American Cancer Society, around 7.0% of total cancer cases occurred in the age group of 0 to 14, observed as neuroblastoma, with most of the cases being reported at an age of 2 to 3 years. There are various immunotherapies and targeted drug therapies that are being developed for treatment of neuroblastoma which are expected to further lead to the growth of its pipeline in the future.

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Neuroblastoma is the most common type of cancer found in children, diagnosed mostly at the age of 1 year, characterized by broad range of clinical behavior. Neuroblastoma is derived from primordial neural crest cell which ultimately present into the sympathetic ganglia and adrenal medulla. It has been stated that the chances of survival in an event free from neuroblastoma are less than 50.0%. Neuroblastoma in chest can cause wheezing, chest pain, drooping eyelids and unequal pupils. The disease usually metastasized in bone marrow, skin, liver and bones until it is diagnosed. Abdominal pain, swelling in legs and altered bowel habits are the common symptoms of abdominal neuroblastoma. Fever, shortness of breath, high blood pressure, watery diarrhea and uncontrolled eye movement are the less common symptoms of neuroblastoma. Scientist have also concluded that neuroblastoma can also occurs due to genetic mutation. The elevation of level of urinary catecholamine is the primary evidence of neuroblastoma.

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Some of the key players having a pipeline of neuroblastoma therapeutics include AstraZeneca Plc, Celgene Corporation, Progenics Pharmaceuticals, Inc., Novartis AG, Abbvie, Inc., MabVax Therapeutics Holdings, Inc., Pfizer Inc., Syros Pharmaceuticals, Inc., Array BioPharma, and Takeda Pharmaceutical Company Limited.

Anal Cancer Therapeutics Pipeline Analysis 2017 – Patent, Designation and Development

Anal Cancer Therapeutics Pipeline Analysis

Anal cancer therapeutic pipeline analysis is expected to increase owing to increasing incidence globally, majorly in older adults. Major factors driving towards the pipeline growth for anal cancer include growing rate of sexually transmitted diseases and aging population. Additionally, increasing awareness regarding health issues among people is another major factor fueling the pipeline growth for anal cancer. According to American Cancer Society, the prevalence of anal cancer has increased with increasing older population. Around 8,200 new cases for anal cancer are estimated to be diagnosed with in 2017, in the U.S., out of which 5,250 cases are estimated to be present in women and 2,950 are estimated to be present in men. The disease affecting females more commonly as compared to the males.

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Merck Sharp & Dohme Corp., is in the process of introducing a compound, Pembrolizumab. The compound is in Phase II clinical stage, and is being tested for its safety and efficacy in a 36-week trial. Pembrolizumab is a programmed cell death 1 ligand 2 protein inhibitor and is given intravenouly. Advaxis, Inc., is also testing on safety and efficacy of compound – ADXS11-001, which is in Phase II stage of development. Eli Lilly and Company, is developing a compound Prexasertib which is being tested for its safety and efficacy for patients diagnosed with anal squamous cell carcinoma. Prexasertib is a checkpoint kinase 1 inhibitor. Oryx GmbH & Co. KG, is developing a compound, P16_37-63 peptide combined with Montanide ISA-51 VG, which is in Phase I clinical development stage. P16_37-63 peptide combined with Montanide ISA-51 VG is an immunostimulant and is being developed with subcutaneous route of administration. ISA Pharmaceuticals B.V., is in the process of developing a compound HPV-16 vaccine, which is an immunostimulant and is currently in Phase I/II. It is therapeutic vaccination against human papillomavirus type 16 for the treatment of anal intraepithelial neoplasia in HIV positive men.

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Some of the key having a pipeline of anal cancer therapeutics include Advaxis, Inc., Amgen Inc., Atara Biotherapeutics Inc, Bayer AG, Cell Medica Ltd., Eli Lilly and Company, Genticel S.A., ISA Pharmaceuticals B.V., Merck & Co Inc, Millennium Pharmaceuticals Inc., Novartis AG, Ono Pharmaceutical Co., Ltd., Oryx GmbH & Co. KG, PDS Biotechnology Corporation, Sun Pharma Advanced Research Company Ltd., Taiwan Liposome Company, Ltd.