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PB Start of Rabies Antibody Product Clinical

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0
quote:

aossa schreef:

Rabies monoclonal antibodies

50 milj. doden per jaar
Zoveel doden nu ook weer niet: Uit het bericht: 40.000 tot 70.000 doden per jaar
aossa
0
quote:

dedokter schreef:

[quote=aossa]
Rabies monoclonal antibodies

50 milj. doden per jaar [/quote]

Zoveel doden nu ook weer niet: Uit het bericht: 40.000 tot 70.000 doden per jaar
Klopt, die $$$-tekens in beide ogen deden het ;-)
gogogoo
0
Bharat Biotech launches anti-rabies vaccine
Tuesday December 19 2006 00:00 IST

IANS

HYDERABAD: Bharat Biotech International Ltd (BBIL) on Monday launched a new anti-rabies vaccine Rabirix that can be used both for prevention as also for treatment in case of infection due to animal bite or contact with saliva of an infected animal.

Rabirix has been indigenously developed by BBIL and "can be used for both prophylactic (vaccine-pre bite) and therapeutic (post bite) treatments", said Krishna M Ella, chairman and managing director at the launch. Julie Gerberding, director of the US-based Centres for Disease Control and Prevention (CDC), was also present.

Rabirix is a purified vero cell based rabies vaccine (PVRV), which has been extensively evaluated clinically for pre-bite and post-bite applications, and has proven to be well tolerated with minimal or no side effects.

The immune sera samples from phase III clinical trials have been analysed at the Pune-based National Institute of Virology and the efficacy of the product has been established.

Rabies is an acute viral encephalitis transmitted from an infected animal to human by exposure to saliva.

Human infection with rabies is nearly always secondary to animal bite, with dog being the major reservoir for human Rabies. Once clinical symptoms have occurred, the disease is almost invariably fatal.

No tests are currently available to diagnose rabies infection in humans before the onset of clinical disease.

Four million people are exposed to the rabies virus worldwide every year and 60,000 people fall victim to it. In India, three million people undergo anti-rabies treatment and 30,000 deaths are reported annually which accounts for 50 percent of mortality from rabies worldwide.

"The rabies vaccines contribute approximately 50 percent of the vaccine market in India in terms of value. Currently, the market size of rabies vaccines is estimated to be around Rs 2.5 billion," said Ella.

BBIL has created a dedicated marketing division christened IMMUTIKA (Immunisation and Tika) to promote vaccines.

www.newindpress.com/NewsItems.asp?ID=...

-=-=-

Ik ben benieuwd hoeveel het vaccin kost.
pim f
0
Rabies and snake bite care boost
By Immogen Foulkes
BBC News

Rabies treatment supplies are limited in poorer countries. A global US$10million plan to improve treatment of rabies, snake bites and scorpion stings is being drawn up by the World Health Organization (WHO). Experts are meeting in Geneva on Wednesday to consider the issue.

The WHO says thousands of people - mainly the young - die unnecessarily each year because they do not have access to the treatment they need. The new plan should make available millions more doses of anti-rabies serum and anti-snake bite venom.

The WHO estimates that more than 12 million people are attacked each year by dogs, snakes or scorpions. Around 8 million ought to have precautionary treatment for rabies following a dog bite but only 6% get it. Rabies remains the 10th most common cause of death from infections in humans.
It is a disease which is 100% fatal if untreated - but also 100% preventable if treated early enough with the right drugs.

Production low

However, production of the serum to treat rabies and of anti-venom treatment against snake bites is low because demand has fallen in wealthier countries and profits have dropped. That means the treatments have become either unavailable or unaffordable in the countries - mainly in Africa and Asia - which still desperately need them. Snake bite victims in particular, the WHO says, are forced to rely on traditional remedies. Many die or are left with serious neurological disorders.

Under the new plan, the WHO plans to improve treatment availability by transferring serum production technology to developing countries. It also plans a new global standard of quality control and training for local manufacturers.

Howard Zucker, WHO Assistant Director-General for Health Technologies and Pharmaceuticals, said: "We need to boost local manufacturers' capacity and improve the delivery of products to remote rural areas. "There are effective solutions that could save millions of lives."

news.bbc.co.uk/2/hi/health/6247761.stm
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1
Weinig nieuws........

A phase Ib study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers

ISRCTN ISRCTN12693237
Title of trial/grant title A phase Ib study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers
Acronym N/A
Serial number at source RAB-M-A002
Study hypothesis First time in Asian subjects study of CL184, a human monoclonal antibody cocktail against rabies virus.
Ethics approval Received from 'Ethics R'US', based in Mumbai (India).
Study design Randomised, double-blind, placebo controlled, phase Ib study
Countries of recruitment India
Disease/condition/study domain Post-exposure prophylaxis for World Health Organisation (WHO) category III rabies exposures
Participants - inclusion criteria 1. Healthy volunteers between 19 and 55 years of age
2. No previous treatment with rabies vaccine
3. Body Mass Index (BMI) between 18 and 28 kg/m^2
Participants - exclusion criteria 1. Pregnant women, women planning to become pregnant and breastfeeding women
2. A history of or currently active clinically significant cardiac (including clinically significant abnormalities on Electrocardiogram [ECG] according to Principal Investigator [PI]), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease
Anticipated start date 02/04/2007
Anticipated end date 08/07/2007
Status of trial Ongoing
Target number of participants 44
Interventions Part 1: The study subjects will receive one dose of CL184 intramuscularly at day 0 and will be followed up over 42 days.
Part 2: The study subjects will receive one dose of CL184 on day 0 in combination with rabies vaccine on days 0, 3, 7, 14 and 28.
Primary outcome measure(s) Safety and tolerability: this is assessed throughout the study, i.e., over 42 days.
Secondary outcome measure(s) 1. Neutralising activity: this analysis is made at Day 14 and at all other timepoints up to day 42
2. Pharmacokinetics of CL184: this is a time-dependent parameter and analysis is performed over the full study duration, i.e., 42 days
Sources of funding Crucell Holland BV (The Netherlands)
Contact name Dr Pramod Kabra
Address Dhirubhai Ambani Life Sciences Centre (DALC)
Plot R-282, TTC Area of MIDC
Rabale, Navi
City/town Mumbai
Zip/Postcode 400 701
Country India
Sponsor Crucell Holland BV (The Netherlands)
Address Archimedesweg 5
City/town Leiden
Zip/Postcode 2333 CN
Country Netherlands
Sponsor website: www.crucell.com
Date applied 10/05/2007
Last edited 22/06/2007
Date ISRCTN assigned 22/06/2007

www.controlled-trials.com/ISRCTN12693237
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0
Even draadje naar boven halen:

A phase I study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers
Anticipated start date 06/12/2006
Anticipated end date 18/05/2007
Status of trial Completed
www.controlled-trials.com/mrct/trial/...

A phase Ib study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers
Anticipated start date 02/04/2007
Anticipated end date 08/07/2007
Status of trial Completed
www.controlled-trials.com/mrct/trial/...
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