Roche and Trimeris, Inc. New Trial to Study Investigational Integrase Inhibitor in Combination with FUZEON(R) Once-Daily Dosing Strategy
NUTLEY, N.J. and MORRISVILLE, N.C., July 17 /PRNewswire-FirstCall/ -- Roche and Trimeris, Inc. today announced that patient dosing has begun in a new trial designed to evalute the efficacy and safety of FUZEON(R) (enfuvirtide) in combination with an investigational integrase inhibitor. The trial will also determine whether a novel, simplified FUZEON dosing strategy -- switching from twice-daily dosing to once-daily dosing -- can effectively maintain an undetectable viral load. This study, known as AMICI, is open to patients who are enrolling in an Expanded Access Program (EAP) for an investigational integrase inhibitor. AMICI is also open to additional integrase inhibitor EAP sites interested in becoming an AMICI trial site. FUZEON, co-developed by Roche and Trimeris , is the first and only fusion inhibitor available for the treatment of HIV.
"As new anti-HIV drugs enter the treatment landscape, it is important to conduct studies that provide detailed guidance to clinicians on how to use these agents with drugs, such as FUZEON, that are already in wide use in treatment-experienced patients. This trial is designed to shed light on several key questions," said Calvin J. Cohen, M.D., Research Director, Community Research Initiative of New England. "In addition to providing new data on the combination of FUZEON and an integrase inhibitor in a significant patient cohort, AMICI will provide insight on whether it is possible to simplify dosing of FUZEON to once-daily after undetectable HIV has been achieved. If shown to be a viable option, simplified dosing of FUZEON would be a welcome advance."
More About AMICI (Roche Protocol Number ML20837)
The study, being conducted at centers in the U.S., has a target enrollment of at least 238 HIV-infected, three-class treatment-experienced adults who have not previously been treated with FUZEON or an integrase inhibitor; whose HIV levels are greater than 1000 copies per mL of blood; and who have at least one fully active antiretroviral agent (in addition to FUZEON and the integrase inhibitor) for inclusion in their treatment regimen. The primary endpoint of AMICI is to evaluate the efficacy of this regimen, as measured by proportion of patients with undetectable HIV (less than 50 copies per mL of blood) by week 12. A second primary endpoint will determine whether FUZEON 180mg once daily is as effective as FUZEON 90mg twice daily in maintaining viral suppression for an additional 24 weeks in patients who achieve undetectable HIV by week 12. Those patients who achieve undetectable HIV by week 12 will be randomized to continue receiving 90 mg FUZEON twice-daily or to switch to 180 mg FUZEON (two injections) once-daily.
Additional details about the trial are available at http://www.roche-trials.com or http://clinicaltrials.gov/ct/show/NCT00488059?order=4.
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 complex reaction, 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 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 novel class of anti- HIV drugs called fusion inhibitors. 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; 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.
Roche; Trimeris, Inc.CONTACT: Mike Nelson of Roche, +1-973-562-2409, mike.nelson@roche.com; orCarol Ohmstede of Trimeris, Inc., +1-919-419-6050, cohmstede@trimeris.com;or Joe St. Martin of MS&L, +1-212-468-3731, joe.stmartin@mslpr.com