Navigation Links
Clinical tests for medicines made from genetically modified plants
Date:7/21/2011

This release is available in German.

UK regulators have approved Europe's first clinical trial of a monoclonal antibody produced from genetically modified plants. This landmark decision sets the stage for the testing, in humans, of an anti-HIV product made from genetically modified tobacco plants. It will open the door for trials of additional plant-derived medicines treating a range of diseases.

The trial will test the safety of a plant-derived antibody designed to stop the transmission of HIV between sexual partners when applied directly to the vaginal cavity. If proven safe in the 11 participants, the researchers can then go on to test the effectiveness of the product.

The clinical trial marks the culmination of the EU Framework 6 Pharma-Planta project, which was launched by a consortium of 30 academic and industrial partners in 2004 with 12 million in funding from the European Union. The primary goal was to develop an approved manufacturing process for recombinant pharmaceutical proteins made in plants and take one such product through all the development stages including the pivotal clinical trial.

Most biopharmaceuticals are currently made at great expense in fermentation vats containing bacteria or mammalian cells, but the mass production of medicines in genetically modified plants could reduce costs and therefore make an important contribution to global health, by improving access for the poor in developing countries where diseases such as HIV are a huge problem. In addition, the simple manufacturing process could be transferred to developing countries allowing production "in the region for the region".

The approval granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) is a significant step forwards because it means a plant-based production system can comply with current Good Manufacturing Practice, the strict standards used in the industry to ensure medicine quality and consistency.

Professor Julian Ma, scientific coordinator for Pharma-Planta and Professor of Molecular Immunology at St George's, University of London, said: "This is a red letter day for the field. The approval from the MHRA for us to proceed with human trials is an acknowledgement that monoclonal antibodies can be made in plants to the same quality as those made using existing conventional production systems. That is something many people did not believe could not be achieved."

The clinical trial which is being carried out at the University of Surrey Clinical Research Centre will test a topically-applied anti-HIV microbicide. The active ingredient in the microbicide is a monoclonal antibody called P2G12. If successful, the investigators envisage that P2G12 will be used in combination with other HIV-neutralising antibodies, also produced in plants, to create a broadly protective vaginal microbicide product.

The genetically modified tobacco plants producing P2G12 were grown in state-of-the-art containment greenhouses at the Fraunhofer Institute for Molecular Biology and Applied Ecology, IME in Aachen, Germany, and the antibody was isolated and purified in a custom-designed processing plant on the same site, the first of its kind to be granted a license to manufacture recombinant pharmaceutical products from plants in Europe.

Professor Rainer Fischer, Pharma-Planta coordinator and Fraunhofer IME Director, said: "We now have a facility in Europe for producing modern medicines in transgenic plants that is unique in the world, although this has taken many years and much investment to establish. This approval is a springboard for European plant biotechnology and will enable many important medical products to be realised."


'/>"/>

Contact: Dr. Rainer Fischer
rainer.fischer@ime.fraunhofer.de
49-241-608-511-021
Fraunhofer-Gesellschaft
Source:Eurekalert

Related biology news :

1. Omnicare Clinical Research Re-Brands as Theorem Clinical Research
2. NCI partners with Jackson Laboratory, UC Davis to speed cancer clinical trials
3. TGen Drug Development partners with Imaging Endpoints for comprehensive clinical trial services
4. New clinical trial to test novel approach to treat triple-negative breast cancer
5. The use of placebo in rheumatoid arthritis clinical trials may negatively impact patients
6. Clinical study suggests estrogen levels and breast health can be altered
7. Progress toward the clinical application of autologous induced pluripotent stem cells and gene repair therapy for treatment of familial hypercholesterolemia
8. New cancer drug discovered at U-M heads to clinical trials
9. JAMIA: Evaluating clinical information systems, patients who use PHRs, how clinicians use EHRs
10. Preview of oral presentations at the 1st IOF-ESCEO Pre-Clinical Symposium
11. Press registration open for clinical nutrition conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/13/2017)... -- According to a new market research report "Consumer IAM ... and Authorization), Service, Authentication Type, Deployment Mode, Vertical, and Region - Global ... grow from USD 14.30 Billion in 2017 to USD 31.75 Billion by ... ... MarketsandMarkets Logo ...
(Date:4/11/2017)... 11, 2017 NXT-ID, Inc. (NASDAQ:   ... announces the appointment of independent Directors Mr. Robin D. ... Board of Directors, furthering the company,s corporate governance and expertise. ... Gino Pereira , ... forward to their guidance and benefiting from their considerable expertise ...
(Date:4/5/2017)... KEY FINDINGS The global market ... CAGR of 25.76% during the forecast period of 2017-2025. ... for the growth of the stem cell market. ... MARKET INSIGHTS The global stem cell market is segmented ... The stem cell market of the product is segmented ...
Breaking Biology News(10 mins):
(Date:10/11/2017)... ... ... Disappearing forests and increased emissions are the main causes of the evolving air ... living in larger cities are affected by air pollution related diseases. , That is ... globally - decided to take action. , “I knew I had to take action ...
(Date:10/10/2017)... , ... October 10, 2017 , ... San Diego-based team ... its corporate rebranding initiative announced today. The bold new look is part of ... the company moves into a significant growth period. , It will also expand its ...
(Date:10/10/2017)... ... 10, 2017 , ... Dr. Bob Harman, founder and CEO of VetStem ... The event entitled “Stem Cells and Their Regenerative Powers,” was held ... Harman, DVM, MPVM was joined by two human doctors: Peter B. Hanson, M.D., Chief ...
(Date:10/10/2017)... ... 10, 2017 , ... USDM Life Sciences , the ... sciences and healthcare industries, announces a presentation by Subbu Viswanathan and Jennifer Jaye ... GxP Validation for Agile Cloud Platforms,” will present a revolutionary approach to achieving ...
Breaking Biology Technology: