Showing posts with label medicinal chemistry. Show all posts
Showing posts with label medicinal chemistry. Show all posts

Monday, 2 December 2013

GSK's Cervarix two-dose schedule receives positive opinion from EMA


European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorisation of a two-dose schedule of GlaxoSmithKline's (GSK) cervical cancer vaccine, Cervarix, in girls aged nine to 14. 

Cervarix is a vaccine against certain types of cancer-causing human papillomavirus(HPV).
Cervarix is designed to prevent infection from HPV types 16 and 18, that cause about 70% of cervical cancer cases. These types also cause most HPV-induced genital and head and neck cancers. Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials. Cervarix also contains AS04, a proprietary adjuvantthat has been found to boost the immune system response for a longer period of time.
Cervarix is manufactured by GlaxoSmithKline. An alternative product, from Merck & Co., is known as Gardasil.
The vaccine was developed, in parallel, by researchers at Georgetown University Medical Center, the University of Rochester, theUniversity of Queensland in Australia, and the U.S. National Cancer Institute.

Clinical Trials

Phase III trials have been conducted, including over 18,000 women from 14 countries in Pacific Asia, Europe, Latin America and North America.
As of 2009 the manufacturer was conducting a trial to compare the immunogenicity and safety of Cervarix with Gardasil. Subsequent studies showed Cervarix generated higher antibody levels than Gardasil, the other commercally available HPV vaccine, upon testing seven months later, with twice the level for HPV type 16 and six times for HPV type 18.In addition Cervarix induced twice as many memory B cells as Gardasil for both these HPV strains.


Vaccine description
Target diseasehuman papillomavirus (Types 16 and 18)
TypeProtein subunit

Tuesday, 26 November 2013

ViiV's HIV Drug Recommended for EU Approval

ViiV's HIV Drug Recommended for EU Approval 

read all


ViiV Healthcare, the HIV company established by GlaxoSmithKline and Pfizer in 2009, announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended marketing authorization for Tivicay (dolutegravir) for use in combination with other antiretroviral medicinal products for the treatment of HIV-infected patients. How soon could the drug be approved in the EU? Find out...

Tuesday, 19 November 2013

Bayer/Algeta prostate cancer drug gets Europe OK

 nov 17 2013
 Regulators in Europe have given the green light to Bayer and Algeta's prostate cancer therapy Xofigo.

The marketing authorisation for Xofigo (radium Ra 223 dichloride) granted by the European Commission was expected given that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the drug in September. The alpha-pharmaceutical, which works by binding with minerals in the bone to deliver radiation directly to bone tumours, was approved by the US Food and Drug Administration in May.

Monday, 18 November 2013

Plerixafor , New treatment approaches for patients suffering from frequent bacterial infections

17 nov 2013
Scientists at A*STAR's Singapore Immunology Network (SIgN) have discovered the exact mode of action by plerixafor, a drug commonly prescribed to stimulate immune responses in patients suffering from neutropenia, which causes them to become prone to oral, skin, genital infections and in worst cases, a fatal whole-body infection. A better understanding of the drug's mechanism can improve its usage to more effectively reduce risk of infections in these patients.
Scientists at SIgN employed cutting-edge imaging techniques to analyze the effects of plerixafor on the white blood cell activity in the study which was published in the Journal of Experimental Medicine (JEM).
Neutrophil Mobilization via Plerixafor
Neutropenia is a condition characterized by the lack of a type of white blood cells, also known as neutrophils, in one's blood circulation. Plerixafor increases the concentration of these white blood cells in the blood by inhibiting a protein called CXCR4. This inhibition prevents neutrophils in the blood stream from returning to the bone marrow, which is the primary compartment where the white blood cells are stored and released. It is therefore commonly accepted that the efficacy of the drug arises only from the release of these white blood cells from the bone marrow.
However, scientists at SIgN found that the inhibition of CXCR4 by the drug actually plays a dual role - It increases the neutrophil count in the blood through their release from the lungs, while simultaneously promoting their retention in the blood stream. Discovery of this additional mode of action not only provides a deeper understanding on the drug's mechanism, it also contributes to a more effective utilization of the drug. The ground-breaking study creates the possibility of using a combined drug treatment to maximise release of white blood cells from both the bone marrow and the lungs. The approach may be more effective in reducing the risk of bacterial infections in neutropenic patients.
The team leader, Dr Ng Lai Guan from SIgN said, "We have identified the precise mechanisms of plerixafor treatment, which has important implications on its usage. We can understand through this study the effectiveness or limitations of the drug on certain patients and thereafter craft new clinical approaches to better treat them. Our study forms a conceptual framework to establish improved therapeutic strategies for neutropenia."
Acting Executive Director of SIgN, Associate Professor Laurent Rénia, said, "Basic research as such is important for us to fully understand how drugs work, so that we can put them to best use. This is a study which can potentially be translated into clinical applications to impact the health and lives of neutropenic patients."
Plerixafor (rINN and USAN, trade name Mozobil) is an immunostimulant used to mobilize hematopoietic stem cells in cancer patients. The stem cells are subsequently transplanted back to the patient. The drug was developed by AnorMED which was subsequently bought by Genzyme.
Three of the four nitrogen atoms of the macrocycle 1,4,8,11-tetraazacyclotetradecan are protected with tosyl groups. The product is treated with 1,4-dimethoxybenzene or 1,4-bis(brommethyl)benzene and potassium carbonate in acetonitrile. After cleaving of the tosyl groups with hydrobromic acid, plerixafor octahydrobromide is obtained.Bridger, G.; et al. (1993). "Linked cyclic polyamines with activity against HIV. WO/1993/012096".
The molecule 1,1′-[1,4-phenylenebis(methylene)]bis [1,4,8,11-tetraazacyclotetradecane], consisting of two cyclam rings linked at the amine nitrogen atoms by a 1,4-xylyl spacer, was first synthesised by Fabbrizzi et al. in 1987 to carry out basic studies on the redox chemistry of dimetallic coordination compounds. Then, it was serendipitously discovered by De Clercq that such a molecule, could have a potential use in the treatment of HIV[2] because of its role in the blocking of CXCR4, a chemokine receptor which acts as a co-receptor for certain strains of HIV (along with the virus's main cellular receptor, CD4).Development of this indication was terminated because of lacking oral availability and cardiac disturbances. Further studies led to the new indication for cancer patients
Plerixafor has orphan drug status in the United States and European Union for the mobilization of hematopoietic stem cells. It was approved by the U.S. Food and Drug Administration for this indication on December 15, 2008. In Europe, the drug was approved after a positive Committee for Medicinal Products for Human Use assessment report on 29 May 2009. The drug was approved for use in Canada by Health Canada on December 8, 2011

Thursday, 24 October 2013

Why Antibody Lots Differ Significantly

Featured Story
Since antibodies first attained prominence as research reagents in modern biological science labs, researchers have been perplexed as to why one production lot can differ significantly from the next, in terms of performance. Poor antibody performance has caused the loss of countless hours of research, to say nothing of the mental anguish of the researchers themselves. An antigen is a substance that stimulates the production of antibodies.
fig is Schematic representation of pure and contaminated antibodies carrying histones or histones complexed with DNA. (Source: Biochemistry and Cell Biology)