NUTLEY, N.J. and MORRISVILLE, N.C., July 20 /PRNewswire-FirstCall/ -- Roche and Trimeris, Inc. today announced interim results from BLQ (Below the Level of Quantification), an ongoing study evaluating the use of FUZEON(R) (enfuvirtide) with the most recently-approved boosted protease inhibitor, darunavir/ritonavir (r), in combination with other anti-HIV drugs. The data, which are being presented at the 4th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Sydney, Australia, show that almost two-thirds (64 percent) of three-class, treatment-experienced patients achieved undetectable HIV (less than 50 copies per mL of blood) at 24 weeks, and that baseline sensitivity to darunavir (the amount of resistance to this protease inhibitor prior to the study) did not appear to influence patient response to the regimen.
FUZEON, co-developed by Roche and Trimeris, is the first and only fusion inhibitor available for the treatment of HIV, while darunavir (Prezista(R)) is a commercially available, ritonavir-boosted protease inhibitor, marketed by Tibotec Therapeutics. The BLQ study is sponsored by Roche and Trimeris; patients received darunavir predominantly through co-enrollment in the darunavir compassionate use program.
"Previous studies had provided encouraging -- but limited -- information on the use of enfuvirtide in combination with darunavir/r," said Edwin DeJesus, M.D., Medical Director, Orlando Immunology Center, Florida. "Given that attaining undetectable HIV of less than 50 copies has become the standard of care even in treatment-experienced patients, it is encouraging that so many patients can achieve this result with enfuvirtide and darunavir/r -- two agents widely available to patients and physicians today. Even patients with significant resistance to darunavir responded well to this combination."
About the BLQ Study Results (Poster WEPEB039)
The BLQ study is a prospective, open-label, 24-week, single-arm, multicenter, cohort study conducted in the United States and Australia. The trial was designed to explore the impact of baseline variables -- including darunavir phenotypic sensitivity (prior resistance) -- on virologic responses in highly treatment-experienced patients receiving regimens containing FUZEON and darunavir/r. Patients received the approved dosages of FUZEON and darunavir/r, along with other anti-HIV drugs selected on the basis of treatment history and resistance testing. This protocol-defined interim analysis was conducted when the first half of total enrolled patients completed their week 24 assessments.
Of 63 eligible patients enrolled, 62 had at least one dose of trial medication and a safety follow-up at day seven and were included in the safety analysis. A total of 58 patients who received at least one dose of trial medication and received at least one post-baseline efficacy assessment at week 4 were included in the intent-to-treat (ITT) efficacy analysis. Of the 58 patients in the ITT population, results for 52 patients were available for evaluation of phenotypic resistance to darunavir.
Key results:
-- 64 percent of patients achieved undetectable HIV of less than 50 copies
per mL of blood; 78 percent of patients achieved undetectable HIV of
less than 400 copies per mL of blood; and 86 percent of patients
achieved a viral load reduction of at least 1 log10
-- The mean reduction in HIV levels was -2.39 log10
-- When virologic response was analyzed as a function of patients'
baseline phenotypic sensitivity to darunavir, the percentages of
patients achieving less 50 than copies per of mL blood were similar in
the three groups of patients: 67 percent undetectable for patients with
a low levels of resistance (fold change of less than 10); 70 percent
undetectable for patients with medium levels of resistance (fold change
of 10 or greater and less than or equal to 40); and 67 percent
undetectable for patients with high levels of resistance (fold change
greater than 40)
-- Treatment with FUZEON and darunavir/r with other anti-HIV drugs was
generally well tolerated. A total of 11 serious adverse events were
reported in seven patients. Two of these patients discontinued therapy
due to their adverse events. An additional patient discontinued
therapy due to an adverse event not considered to be serious. One death
(unrelated to study drug) was reported in a patient with sepsis,
worsening anemia, and worsening renal insufficiency.
Facts About FUZEON
Administered via one 90 mg injection twice-daily, FUZEON is the first and only fusion inhibitor for the treatment of HIV. Unlike other HIV drugs that work after HIV has entered the human immune cell, FUZEON works outside the CD4 cell, blocking HIV from entering the cell. For this reason, FUZEON is effective in treatment-experienced patients who have developed resistance to other anti-HIV drugs, though patients may still develop resistance to FUZEON. FUZEON was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in March 2003 on the basis of 24-week data, and was granted traditional (full) approval on Oct. 15, 2004 on the basis of long-term 48-week data.
FUZEON is indicated for use in combination with other antiretroviral agents for the treatment of HIV in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Injection Site Reactions (ISRs): ISRs are the most common adverse events associated with FUZEON. ISRs occurred in 98% of patients studied and 4% discontinued FUZEON due to ISRs. Signs/symptoms may include pain and discomfort, hardened skin, redness, bumps, itching and swelling. Eleven percent of patients had local reactions that required analgesics or limited usual activities.
Pneumonia: An increased rate of bacterial pneumonia was observed in subjects treated with FUZEON in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to FUZEON use. Patients with HIV infection should be carefully monitored for signs and symptoms of pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.
Hypersensitivity Reactions: Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on rechallenge. Hypersensitivity reactions have included individually and in combination: rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune mediated and have been reported in subjects receiving FUZEON include primary immune complexreaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome.
Administration with Biojector(R)2000: Nerve pain (neuralgia and/or parethesia) lasting up to six months associated with administration at anatomical sites where large nerves course close to the skin, bruising and hematomas have occurred with the use of the Biojector 2000 needle-free device for administration of FUZEON. Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding.
Other Adverse Events: The events most frequently reported in patients receiving FUZEON plus an optimized background regimen were diarrhea (32%), nausea (23%) and fatigue (20%). These events were seen at a lower incidence in patients taking a FUZEON-based regimen compared to those receiving an optimized background regimen without FUZEON when taking into account the uneven number of patients in each arm and the length of time they are in that arm. As measured in number per 100 patient years, the incidence was: diarrhea (38 per 100 patient-years in subjects receiving FUZEON-based regimens vs. 73 per 100 patient-years in patients who did not receive FUZEON), nausea (27 vs. 50, respectively) and fatigue (24 vs. 38, respectively).
Roche in HIV
Roche is at the forefront of efforts to combat HIV infection and AIDS, committed for more than 15 years to groundbreaking research and development of new drugs and diagnostic technology. The objective is to provide tailored treatment solutions and an improved standard of care worldwide for those people living with HIV.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com/ or http://www.roche.us/.
About Trimeris, Inc.
Trimeris, Inc. is a biopharmaceutical company engaged in the 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. For more information about Trimeris, please visit the Company's website 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; we are dependent on third parties for the sale, marketing and distribution of our drug candidates; 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 16, 2007 and its periodic reports filed with the SEC.
