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Tag Archives: CANCER
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Novavax announces positive preclinical data for vaccine against influenza
Novavax announces positive preclinical data for vaccine against influenza
Novavax has announced positive preclinical results for its virus-like particle (VLP) vaccine candidate against A (H7N9) influenza.
The study examined the immunogenicity, the ability to provoke an immune response, and efficacy of two doses of its A(H7N9) VLP vaccine candidate against a lethal wild-type challenge mouse model.
There were three control groups, including Novavax’ non-homologous A(H7N3) VLP vaccine candidate, its A(H5N1) VLP vaccine candidate, and a placebo. All vaccine candidates were administered with or without Iscomatrix, a saponin-based adjuvant.
read all at
http://www.pharmaceutical-technology.com/news/newsnovavax-announces-positive-preclinical-data-for-vaccine-against-influenza?WT.mc_id=DN_News
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Gene Therapy for Melanoma: Progress and Perspectives
FIGURE 1.
Schematic representation of the wild type counterpart of the typically used recombinant viral vectors. (A) Gammaretroviruses and (B) lentiviruses share similar structures, but differ greatly in their genomes and their impact on cellular function. Gag, pro, pol and env genes encode structural proteins of the capsid, protease, reverse transcriptase and envelope proteins, respectively. The additional lentiviral genes perform regulatory functions as well as alter cellular function. (C) The serotype 5 adenovirus has a protein capsid (non-enveloped) and a large, complex genome that encodes critical genes for viral replication (E1a, E1b) as well as structural and functional genes that regulate both viral and cellular activities.
Introduction
Gene therapy, the therapeutic transfer of genetic information to a target cell, continues to be a promising alternative in the fight against cancer. In the case of melanoma, the use of an experimental treatment is justified since this disease is incurable in its advanced stages. Is gene therapy a viable option for the treatment of melanoma patients? In this chapter, we will attempt to answer this question by exploring the intersection between the technology of gene therapy and the biology of melanoma, a point at which opportunities for intervention are revealed.
Gene Therapy for Melanoma: Progress and Perspectives
[1] Cancer Institute of Sao Paulo, University of Sao Paulo School of Medicine, Brazil
[2] University of Sao Paulo, Biomedical Sciences Institute, Brazil
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Analysis Of Vical’s Allovectin-7: Best Results Ever In A Melanoma Phase 3 Trial
check this video
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Vical’s (VICL) Allovectin-7 is a pure immune therapy.(1) Which means it does not directly kill cancer cells, but activates the immune system to do so. Vical will soon announce A-7 phase 3 results in Melanoma, but the mechanism of action is not specific to Melanoma, and can be used in any solid tumor cancer.(2) For this reason, I expect that Allovectin-7 will become one of the best selling cancer drugs of all time.
Allovectin-7 is a substance that is being studied as a gene therapy agent in the treatment of cancer, such as malignant melanoma. It is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and ß2 microglobulin – two components of major histocompatibility complex (MHC, class I). It increases the ability of the immune system to recognize cancer cells and kill them.
In 1999, FDA granted Allovectin-7 orphan drug designation for the treatment of invasive and metastatic melanoma.
- Allovectin-7 entry in the public domain NCI Dictionary of Cancer Terms
This article incorporates public domain material from the U.S. National Cancer Institute document “Dictionary of Cancer Terms”.
Vical’s Allovectin-7
Allovectin is a first-class DNA-based immunotherapeutic designed to stimulate both innate and adaptive immune responses in local tumors and distal metastases. The goal is to become a first-line treatment for Stage III and IV melanoma, where it is intended to provide improved efficacy, a better safety profile, and simple outpatient administration.
As last reported, the company is approaching completion of a Phase III registration trial versus chemotherapy in patients with metastatic melanoma. The reporting of end results has had numerous delays, but the results are now expected by Q3.
Outside of Allovectin, Vical has ten clinical trials ongoing, three of those independent and the rest in collaboration. Clearly, Vical is not totally dependent on this immunotherapy though it is the most advanced independent program in the company’s pipeline.
Vical has a market cap of $257M, so clearly a homerun therapy could send the stock soaring.
Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw
Kiran Mazumdar-Shaw, MD, BIOCON
Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw, MD, BIOCON
Biocon is looking at gaining market share and improving its margins with a greater focus on its product mixes and organizational efficiencies. Biocon Chairman and Managing Director Kiran Mazumdar-Shaw tells Financial Express that the company has outpaced the market, despite various challenges and that the pharmaceutical market needs to have a more robust regulatory set-up. Edited excerpts:
READ ALL AT
http://kiranmazumdarshaw.blogspot.in/2013/07/indian-pharma-market-needs-strong.html
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India seeks to cancel Roche cancer patent
India may revoke Roche’s breast cancer drug’s patent using section 66 of the Indian Patents Act
India’s health ministry is looking to revoke Roche’s breast cancer drug’s patent in public interest using powers under section 66 of the Indian Patents Act India may revoke Roche’s breast cancer drug’s patent using section 66 of the Indian Patents Act Related Articles Oramed gets Japanese patent for protein delivery Cipla wins patent case against Roche Alchemia cancer drug gets US patent protection Alchemia gets US patent for oncology platform technology New Delhi: India’s health ministry has asked for a cancellation of patent to Roche’s breast cancer medicine Trastuzumab, using a rarest-of-the-rare provision in the Indian Patents Act.
Read more at: http://www.biospectrumasia.com/biospectrum/news/192436/india-seeks-cancel-roche-cancer-patent#.UfXtuaI3CSo
Kyowa Hakko Kirin Korea begins patient recruitment in phase I/II study of BIW-8962 in lung cancer
Kyowa Hakko Kirin Korea begins patient recruitment in phase I/II study of BIW-8962 in lung cancer
http://www.kyowa-kirin.com/news_releases/2011/pdf/e20110802_04.pdf
http://clinicaltrials.gov/ct2/show/NCT01898156
Kyowa Hakko Kirin Korea Co., Ltd
This Phase 1/2 study is designed to assess the following: safety and tolerability of BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D) in Phase 1 and preliminary efficacy in Phase 2 in subjects with advanced/recurrent lung cancer or mesothelioma.
http://www.myeloma.org.uk/patient-information/drug-development/hcp-drug-scanner/biw-8962/
Compound Suffocates Tumors
Scientists have discovered a new molecule that prevents cancer cells from responding and surviving when starved of oxygen and which could be developed into new treatments for the disease, according to new research published in the Journal of the American Chemical Society.
Cancer Research UK scientists at the University of Southampton found that this molecule targets the master switch—HIF-1—that cancer cells use to adapt to low oxygen levels, a common feature in the disease.
read all at
Find out more:
- Cancer Sciences Unit
- Is it your ambition to help cure cancer? If so, visit: www.southampton.ac.uk/medicine/undergraduate/index.page
Curis phase 1 Cancer Trial for CUDC-427 Begins
CUDC-427, GDC-0917; RG-7459
Genentech Inc (Roche Holding AG)
Curis licenses GDC-0917 from Genentech
Curis Cancer Trial Begins
Curis Inc. has initiated patient dosing in a second Phase 1 dose-escalation study of CUDC-427 that is being conducted using a continuous, twice-daily oral dosing regimen in patients with advanced and refractory solid tumors or lymphoma.
FULL STORY
About CUDC-427 (GDC-0917)
CUDC-427 is an orally bioavailable small molecule that is designed to promote cancer cell death by antagonizing IAP proteins. IAP proteins are a family of functionally and structurally related proteins that promote cancer cell survival by inhibiting programmed cell death, also known as apoptosis, which is a normal process inherent in every cell. Using IAP proteins and other anti-apoptotic factors, cancer cells evade apoptosis in response to a variety of signals, including those provided by anti-cancer agents such as chemotherapy, or naturally occurring inflammatory and immune signals transmitted through members of the tumor necrosis factor, or TNF, family of factors. Evasion from apoptosis is a fundamental mechanism whereby human cancers develop resistance to standard anti-cancer treatments. IAP inhibitors such as CUDC-427 are designed to counteract the effects of IAP proteins, thus shifting the balance away from cancer cell survival and allowing apoptosis to proceed.
CUDC-427 was designed to mimic the endogenous IAP antagonist mitochondrial protein second mitochondria-derived activator of caspases/direct IAP-binding protein (Smac/DIABLO) that is released into the cytoplasm in response to pro-apoptotic stimuli. CUDC-427 has demonstrated single-agent and combination anti-tumor activity in mouse xenograft tumor models when administered orally on a daily schedule, and IND-enabling safety studies have shown it to be well tolerated when dosed daily by oral administration, potentially enabling sustained target inhibition.
In October 2010, an open-labeled, uncontrolled, dose-escalation, Phase I clinical trial of CUDC-427 (NCT01226277; IAM4914g) began in patients with refractory solid tumors or lymphoma. Genentech recently completed this Phase I clinical trial in which 42 people received daily oral doses of CUDC-427 for two weeks, followed by a one week rest period. This 21-day cycle is repeated until disease progression or study discontinuation for any other reason. The primary endpoints of the study include evaluating the safety and tolerability and the pharmacokinetics of CUDC-427 in people with solid tumors or lymphoma and determining the maximum-tolerated-dose and a potential recommended dose for further clinical studies. Secondary endpoints include a preliminary assessment of anti-tumor activity of CUDC-427 and evaluating pharmacodynamic markers. Genentech plans to present full study results at a medical conference in mid-2013. Please refer to http://www.clinicaltrials.gov for additional study details.
About Inhibitor of Apoptosis Proteins
Impairment of programmed cell death or apoptosis often contributes to the formation and progression of cancer, and evasion of apoptosis is one of the primary strategies by which cancer cells develop resistance to anticancer therapies. Inhibitor of apoptosis (IAP) proteins are a family of functionally and structurally related proteins which include X-linked IAP (XIAP), cellular IAPs (cIAP1 and cIAP2), and melanoma IAP (ML-IAP). They confer protection from death-inducing stimuli by exerting a range of biological activities that promote cancer cell survival and proliferation. Some even directly inhibit caspases, critical players in the execution of apoptosis.
Mutations, amplifications and chromosomal translocations of IAP genes are associated with various solid and hematologic cancer types, and increased IAP expression has been associated with an unfavorable prognosis and poor outcome for patients. As a consequence, IAP proteins are considered promising molecular targets for anticancer therapy.
Antibody Effective Against Norovirus
Antibody Effective Against Norovirus
Researchers have released data showing that a monoclonal antibody can neutralize human norovirus. Norovirus causes roughly 20 million cases of acute diarrhea and vomiting annually in the United States, alone. It is also responsible for roughly 800 deaths annually.
FULL STORY
What is Norovirus?
Norovirus is a stomach bug that sets in within 10 hours of transmission and usually lasts up to three days. It is completely different from the flu in that only your stomach is affected. While most people recover completely after three days, norovirus is more serious for young children, the elderly and people with other serious health conditions. Every year 70,000 people are hospitalized and 800 deaths are caused by the virus.
What are the symptoms?
The most common symptoms of norovirus include stomach pain, vomiting, diarrhea and nausea. Some people also experience a low-grade fever, headache and body ache. Because it is common to have continued vomiting and diarrhea during the three days of illness, dehydration is another concern for those affected.
How do you get it?
Norovirus is spread through direct contact with an infected person’s vomit or feces. Most commonly, unwashed hands can be attributed to spreading the virus through surfaces or food. The virus spreads quickly in enclosed spaces like cruise ships, nursing homes and schools.
What is the treatment?
Unfortunately, there are no medications to treat norovirus. Health care providers say the best thing to do is try to stay hydrated, rest and wait for the virus to run its course. People who are unable to keep fluids down may need to receive fluids intravenously.
How can you protect yourself?
Hand washing is the best defense against the norovirus, since no one is immune to the always-changing strains of the virus. However, new research has found hand sanitizers are not affective in killing the virus. Avoid direct contact with anyone who is infected and pay close attention to cleaning and preparing food. Also, anyone who is infected should not prepare food. Use disinfectants to wipe down all surfaces that have come in contact with someone who is infected. Also, launder infected clothes immediately on the longest wash cycle to help from spreading the virus.
Biosimilars applications under review by EMA – 2013 Q2
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or ‘reference drug’.
read all at
http://www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-2013-Q2
New Drug Approvals 