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BiovaxID
Biovest International, Inc ( OTCQB: BVTI) was a Minneapolis-based biotechnology company. Their active immunotherapy, BiovaxID, is a cancer vaccine whose first indication was intended to be consolidation/adjuvant therapy of follicular Non-Hodgkin's Lymphoma. Biovest filed to reorganize under chapter 11 bankruptcy in 2014, BiovaxID was refused European marketing authorization in 2015, and Biovest's stock listing was revoked in 2017. BiovaxID (dasiprotimut-T) Unlike a preventative vaccine, such as for measles or mumps, BiovaxID is administered as a therapeutic cancer vaccine, designed to stimulate and "train" the patient's immune system to respond and attack cancerous cells, even long after therapy has been stopped — each vaccine being unique to that particular patient. Beginning with an excisional (>2 cm) lymph node biopsy, tumor cells are fused with Biovest's proprietary mouse/human heterohybridoma in order to induce secretion of normally surface-bound tumor immunoglobu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cancer Vaccine
A cancer vaccine is a vaccine that either treats existing cancer or prevents development of cancer. Vaccines that treat existing cancer are known as ''therapeutic'' cancer vaccines or tumor antigen vaccines. Some of the vaccines are "autologous", being prepared from samples taken from the patient, and are specific to that patient. Some researchers claim that cancerous cells routinely arise and are destroyed by the immune system (immunosurveillance); and that tumors form when the immune system fails to destroy them. Some types of cancer, such as cervical cancer and liver cancer, are caused by viruses (oncoviruses). Traditional vaccines against those viruses, such as the HPV vaccine and the hepatitis B vaccine, prevent those types of cancer. Other cancers are to some extent caused by bacterial infections (e.g. stomach cancer and ''Helicobacter pylori''). Traditional vaccines against cancer-causing bacteria ( oncobacteria) are not further discussed in this article. Method One app ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cancer Vaccine
A cancer vaccine is a vaccine that either treats existing cancer or prevents development of cancer. Vaccines that treat existing cancer are known as ''therapeutic'' cancer vaccines or tumor antigen vaccines. Some of the vaccines are "autologous", being prepared from samples taken from the patient, and are specific to that patient. Some researchers claim that cancerous cells routinely arise and are destroyed by the immune system (immunosurveillance); and that tumors form when the immune system fails to destroy them. Some types of cancer, such as cervical cancer and liver cancer, are caused by viruses (oncoviruses). Traditional vaccines against those viruses, such as the HPV vaccine and the hepatitis B vaccine, prevent those types of cancer. Other cancers are to some extent caused by bacterial infections (e.g. stomach cancer and ''Helicobacter pylori''). Traditional vaccines against cancer-causing bacteria ( oncobacteria) are not further discussed in this article. Method One app ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Rescue Fusion Hybridization
Rescue fusion hybridization is a process used to manufacture some therapeutic cancer vaccines in which individual tumor cells obtained through biopsy are fused with an antibody-secreting cell to form a heterohybridoma. This cell then secretes the unique idiotype, or immunoglobulin antigen characteristic of the individual tumor, which is purified for use as the vaccine. It is used to produce the BiovaxID vaccine for follicular lymphoma Follicular lymphoma (FL) is a cancer that involves certain types of white blood cells known as lymphocytes. The cancer originates from the uncontrolled division of specific types of B-cells known as centrocytes and centroblasts. These cells normal .... References Vaccination Oncology Chemical processes {{biochem-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Orphan Drug
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy in many countries and has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug research and development. In the U.S. and the EU, it is easier to gain marketing approval for an orphan drug. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to encourage development of drugs which would otherwise lack sufficient profit motive to attract corporate research budgets and personnel. Definition According to the US Food and Drug Administration (FDA), an orphan drug is defined as one "intended for ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biotechnology Companies Of The United States
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used by Károly Ereky in 1919, meaning the production of products from raw materials with the aid of living organisms. Definition The concept of biotechnology encompasses a wide range of procedures for modifying living organisms according to human purposes, going back to domestication of animals, cultivation of the plants, and "improvements" to these through breeding programs that employ artificial selection and hybridization. Modern usage also includes genetic engineering as well as cell and tissue culture technologies. The American Chemical Society defines biotechnology as the application of biological organisms, systems, or processes by various industries to learning about the science of life and the improvement of the value of materials ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Avax Technologies
Avax Technologies, Inc. is a Philadelphia-based biotechnology company whose most advanced product candidate is MVax for melanoma. MVax is a cancer vaccine that received a Special Protocol Assessment agreement with the FDA in October 2006, and subsequently began a Phase III registration clinical trial in November 2007. In previous studies, MVax demonstrated a 5-year overall survival rate (OS)of 44% and response rate of 35% (13% CR, 22% PR). AC Vaccine Method A tumor sample is removed from a patient, then treated with the hapten 2,4-Dinitrophenol. When reinjected back into the patient, the hapten will cause an enhanced immune response against the cancer cells. Product Candidates MVax Started May 2007. Currently in a Phase III trial for Stage IV Melanoma. MVax’s Phase II response rate of 35% (CR + PR) in combination with low-dose IL-2 compares favorably to the Phase II results of other melanoma cancer vaccines such as Vical’s Allovectin-7 (11% CR + PR) and BioVex’s Onc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not onl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Provenge
Sipuleucel-T, sold under the brand name Provenge, developed by Dendreon Pharmaceuticals, LLC, is a cell-based cancer immunotherapy for prostate cancer (CaP). It is an autologous cellular immunotherapy. Medical uses Sipuleucel-T is indicated for the treatment of metastatic, asymptomatic or minimally symptomatic, metastatic castrate-resistant hormone-refractory prostate cancer (HRPC). Other names for this stage are metastatic castrate-resistant (mCRPC) and androgen independent (AI) or (AIPC). This stage leads to mCRPC with lymph node involvement and distal (distant) tumors; this is the lethal stage of CaP. The prostate cancer staging designation is T4,N1,M1c. Treatment method A course of treatment consists of three basic steps: * The patient's white blood cells, primarily dendritic cells, a type of antigen-presenting cells (APCs), are extracted in a leukapheresis procedure. * The blood product is sent to a production facility and incubated with a fusion protein (PA2024) cons ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Dendreon
Dendreon is a biotechnology company. Its lead product, Provenge (known generically as sipuleucel-T), is an immunotherapy for prostate cancer. It consists of a mixture of the patient's own blood cells (autologous, with dendritic cells thought to be the most important) that have been incubated with the Dendreon PAP-GM-CSF fusion protein. Phase III clinical trial results demonstrating a survival benefit for prostate cancer patients receiving the drug were presented at the AUA meeting on April 28, 2009. After going through the approval process, Provenge was given full approval by the FDA on April 29, 2010. Dendreon's stock value fell 66% on August 4, 2011, after abandoning its forecast for its debut drug Provenge. In November 2014, Dendreon filed for Chapter 11 bankruptcy protection and shortly afterwards announced that it had reached agreements on the terms of a financial restructuring with certain bond holders. On February 20, 2015, Valeant Pharmaceuticals received approval to pu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Median Follow-up
In statistics, median follow-up is the median time between a specified event and the time when data on outcomes are gathered. The concept is used in cancer survival analyses. Many cancer studies aim to assess the time between two events of interest, such as from treatment to remission, treatment to relapse, or diagnosis Diagnosis is the identification of the nature and cause of a certain phenomenon. Diagnosis is used in many different disciplines, with variations in the use of logic, analytics, and experience, to determine " cause and effect". In systems engin ... to death. This duration is generically called survival time, even if the end point is not death. Time-to-event studies must have sufficiently long follow-up durations to capture enough events to reveal meaningful patterns in the data. A short follow-up duration is appropriate for studying very severe cancers with poor prognoses, whereas a long follow-up duration is better suited to studying less-severe disease ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Public Company
A public company is a company whose ownership is organized via shares of stock which are intended to be freely traded on a stock exchange or in over-the-counter markets. A public (publicly traded) company can be listed on a stock exchange (listed company), which facilitates the trade of shares, or not (unlisted public company). In some jurisdictions, public companies over a certain size must be listed on an exchange. In most cases, public companies are ''private'' enterprises in the ''private'' sector, and "public" emphasizes their reporting and trading on the public markets. Public companies are formed within the legal systems of particular states, and therefore have associations and formal designations which are distinct and separate in the polity in which they reside. In the United States, for example, a public company is usually a type of corporation (though a corporation need not be a public company), in the United Kingdom it is usually a public limited company (plc), i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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