- Pacgen Biopharmaceuticals Receives Approval for Phase I/II Clinical Trial of PAC-113 for Oral Candidiasis
Pacgen Biopharmaceuticals Receives Approval for Phase I/II Clinical Trial of PAC-113 for Oral Candidiasis
Vancouver, BC, Canada, March 7, 2006 – Pacgen Biopharmaceuticals Corporation (“Pacgen”) announced today that it has received approval from the Institutional Review Board (IRB) at the University of Southern California in Los Angeles to conduct a Phase I/II clinical study of PAC-113 mouthrinse for the treatment of oral candidiasis in HIV seropositive individuals. The clinical study may begin immediately. The study protocol was submitted to the active Investigational New Drug Application (IND) with the United States Food and Drug Administration (US FDA) in early November 2005.
“Obtaining IRB approval at a leading academic institution such as University of Southern California School of Dentistry, Diagnostic Sciences Division for Oral Medicine provides enormous credibility to our lead candidate PAC-113 and our planned clinical development program”, said David J. Cheng, Ph.D., President and CEO of Pacgen. He added, “we are pleased that we can start enrolling patients at USC in our clinical trial and are awaiting IRB approval from another leading U.S. university.”
About the Investigator
The Investigator for this study at University of Southern California School of Dentistry (USCSD) in Los Angeles will be Dr. Mahvash Navazesh, BS, DMD, Associate Professor of Oral Medicine and Chair of Diagnostic Sciences Division at USCSD.
About the disease
HIV Oral Candidiasis is an AIDS-defining opportunistic illness that is highly prevalent in HIV-infected individuals. Other immunocompromised individuals, including cancer patients receiving chemotherapy, are also susceptible to oral fungal infections. The disease causes pain, inability to eat, and increased risk of additional infection. Oral candidiasis outbreaks often recur and maintenance therapy may be needed.
About the study
The Phase I/II study of PAC-113 mouthrinse in HIV seropositive individuals with oral candidiasis is intended to assess the efficacy in eliminating clinical signs and symptoms of oral Candida infections and to evaluate the microbiological response of Candida to PAC-113, as well as evaluate the safety and tolerance of PAC-113 mouthrinse administered orally. It is a randomized, examiner-blinded, parallel design clinical trial with two treatment arms: PAC-113 mouthrinse and Nystatin oral suspension, a widely used treatment.
PAC-113 is a 12 amino acid peptide, synthetically produced fragment of histatin 3, which is a normal component of human saliva. PAC-113 has demonstrated a high level of in vitro activity against Candida infections, including drug-resistant HIV patient isolates. The benefits of this product over current treatments are its demonstrated safety in humans related to its natural origin and the reduced risk of drug resistance due to PAC-113’s unique mechanism of action. The drug product containing PAC-113 drug substance is formulated as a transparent solution with a pH of approximately 6.0.
Pacgen Biopharmaceuticals Corporation is an international biotechnology company specializing in the development of innovative peptide therapeutics for the prevention and treatment of infectious diseases and immune system regulations where current therapies are inadequate or ineffective. Pacgen’s current clinical programs include drug candidates for the treatment of oral candidiasis in HIV-infected patients (phase I/II), prevention of ventilator-associated pneumonia (preclinical), and treatment of chronic Hepatitis B & C infections (research & development). Pacgen is headquartered in Vancouver, British Columbia, Canada. For additional information, please visit www.pacgenbiopharm.com.
David J. Cheng, Ph.D.
Pacgen Biopharmaceuticals Corporation
Tel: (604) 436-4388
Fax: (604) 436-4380