19.01.2006 – 13:30
Roche and Trimeris Announce Selection of Two Next Generation HIV Fusion Inhibitor Drug Candidates for Development
Basel, Switzerland and Morrisville, North Carolina (ots/PRNewswire)
- Early Preclinical Data on TR-291144 and TR-290999 to be Presented at Major HIV Congress in February
BASEL, Switzerland and MORRISVILLE, North Carolina, January 19 /PRNewswire/ --
Roche and Trimeris today announced their collaboration in the co-development of two new HIV fusion inhibitor peptides. The peptides, TR-291144 and TR-290999, are being developed with the goal of achieving highly potent and durable suppression of the HIV virus while simultaneously improving convenience for patients through less frequent dosing such as once weekly administration. Data from the early pre-clinical studies evaluating TR-291144 and TR-290999 will be presented at an upcoming international HIV congress in February.
"Early studies with these new peptide fusion inhibitors have shown very promising results" said Dr Nick Cammack, Head of Virology Research, Roche. "These studies, along with our other ongoing NNRTI and CCR5 discovery programmes, demonstrate Roche's commitment to finding new and improved approaches to fighting HIV/AIDS."
First Fusion Inhibitor, FUZEON, continues to provide much needed hope for HIV patients facing treatment failure
FUZEON(R) (enfuvirtide), co-developed by Roche and Trimeris (Nasdaq: TRMS) and launched worldwide in 2003, was the first major breakthrough in the treatment of HIV since 1997. FUZEON ushered in a completely new approach to fighting HIV by blocking the virus from entering human immune cells. It is the first and only fusion inhibitor available for the treatment of HIV.
"We are very encouraged by the prospect of co-developing the next generation of fusion inhibitor peptides with our colleagues at Roche," said Steven D. Skolsky, CEO, Trimeris, Inc. "This is a significant milestone which further validates our peptide technology platform."
In vitro data on peptides that are precursors to TR-291144 and TR-290999 were presented at the First Conference on Entry Inhibition of HIV in December 2005. They demonstrated significant potency and durability.
Notes to Editors:
For further information on FUZEON and Roche in HIV please visit: http://www.roche-hiv.com/Newsandfeatures/fuzeon.cfm
Recommendations - The updated DHHS guidelines (October 6, 2005) are available online: http://aidsinfo.nih.gov/guidelines/.
The Panel on Clinical Practices for Treatment of HIV Infection convened by the US Department of Health and Human Services (DHHS) provides guidance on the management of HIV-infected patients. It also provides guidance on changing an antiretroviral therapy regimen for virologic failure, for which the latest recommendations include:
- Using the treatment history and past and current resistance test
results to identify active agents (preferably at least two fully
active agents) to design the new regimen. A fully active agent is
one likely to demonstrate antiretroviral activity on the basis of
both the treatment history and susceptibility on drug-resistance
- Adding a drug with activity against drug-resistant virus (e.g. a
potent ritonavir-boosted PI) and a drug with new mechanism of
action (e.g. HIV entry inhibitor) to an optimised background
antiretroviral regimen can provide significant antiretroviral
Growing body of evidence, RESIST 1&2 / POWER 1&2 / TORO 1&2 - Collectively the data from all six studies, in over 2,500 patients, suggest a new paradigm in the management of triple class-experienced patients. Latest data adds to growing Body of Evidence - Latest Boosted Protease Inhibitors (lopinavir/r, tipranavir/r and the investigational agent TMC 114/r) all work better in combination with FUZEON.
RESIST Phase III tipranavir trials
- Over 24 weeks, almost double the proportion of patients who received
FUZEON plus boosted tipranavir showed a 90% drop in viral load
compared with patients not receiving FUZEON
POWER Phase II TMC114 dosing trials
- Preliminary data over 24 weeks in the combined TMC114 trials showed
that almost double the proportion of patients who received FUZEON plus
the investigational boosted PI TMC114 achieved a viral load below 50
copies/ml compared with patients not receiving FUZEON
- A remarkable 67% of the patients receiving FUZEON plus boosted
TMC114 reached an undetectable viral load (<50 copies/ml)
- In the POWER 1 trial 63% of the patients receiving FUZEON plus
boosted TMC114 reached an undetectable viral load (<50 copies/ml)
compared with 56% of patients receiving TMC114 alone
- Preliminary data in the POWER 2 trial showed that 64% of the
patients receiving FUZEON plus boosted TMC114 reached an
undetectable viral load (<50 copies/ml) compared with 30% of
patients receiving TMC114 alone
TORO Phase III FUZEON trials
- Over 24 weeks, double the proportion of patients who received FUZEON
plus boosted lopinavir achieved an undetectable viral load (<50
copies/ml) compared with patients not receiving FUZEON
Headquartered in Basel, Switzerland, Roche (LSE: ROG) is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.
About Trimeris, Inc.
Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the discovery, development and commercialization of novel therapeutic agents for the treatment of viral disease. The core technology platform of fusion inhibition is based on blocking viral entry into host cells. FUZEON, approved in the U.S., Canada and European Union, is the first in a new class of anti-HIV drugs called fusion inhibitors. Trimeris is developing FUZEON and future generations of peptide fusion inhibitors in collaboration with F. Hoffmann-La Roche Ltd. For more information about Trimeris, please visit the company's Web site at http://www.trimeris.com.
Trimeris Safe Harbor Statement
This document and any attachments may contain forward-looking information about the Company's financial results and business prospects that involve substantial risks and uncertainties. These statements can be identified by the fact that they use words such as "expect," "project," "intend," "plan," "believe" and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially are the following: there is uncertainty regarding the success of research and development activities, regulatory authorizations and product commercializations; the results of our previous clinical trials are not necessarily indicative of future clinical trials; and our drug candidates are based upon novel technology, are difficult and expensive to manufacture and may cause unexpected side effects. For a detailed description of these factors, see Trimeris' Form 10-K filed with the Securities and Exchange Commission on March 11, 2005 and its periodic reports filed with the SEC.
ots Originaltext: Roche Pharmaceuticals
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