- Pacgen Biopharmaceuticals Retains Dow Pharmaceutical Sciences for PAC-113 Phase I/II Human Clinical Trials
Pacgen Biopharmaceuticals Retains Dow Pharmaceutical Sciences for PAC-113 Phase I/II Human Clinical Trials
Vancouver, BC, Canada, April 11, 2005 – Pacgen Biopharmaceuticals Corporation (“Pacgen”), an international biotechnology company specializing in the development of innovative peptide therapeutics for the prevention and treatment of infectious diseases and immune system regulations, announced today it has retained Dow Pharmaceutical Sciences (“Dow”), a leading clinical manufacturing and research organization (CMO/CRO) for regulatory, clinical, manufacturing and distribution services for its PAC-113 phase I/II human clinical trials.
Dow will provide services in support of regulatory strategy, planning, review of IND, filing of updated regulatory CMC and clinical submissions for PAC-113 Mouth Rinse, clinical study monitoring, data management, study report, manufacturing, labelling and shipment of GMP clinical supplies for PAC-113 Mouth Rinse for HIV oral candidiasis phase I/II human clinical study.
"This is a critical milestone in our development plan of our PAC-113 phase I/II human clinical trials, the first patient is expected to be enrolled by July 2005,” said David J. Cheng, Ph.D., President and CEO of Pacgen. "One of the main reasons we selected Dow for this project is its reputation for generating accurate and on-time reports and its strong and well-built relationship with the FDA. We are very optimistic that this partnership will keep our aggressive product development plans on track."
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 HIV oral candidiasis (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 with Research and Development facilities at the National Tsing Hua University in Hsinchu, Taiwan. For additional information, please visit www.pacgenbiopharm.com.
Dow Pharmaceutical Sciences provides regulatory strategy development, non-clinical and clinical study design and management, and regulatory filings required to take topical products from inception through FDA approval. This includes phase I-III trials at Dow’s two clinical sites. In addition, Dow provides analytical method development and validation, stability testing, clinical materials manufacturing, and labelling and distribution of clinical trial materials. Dow also specializes in the development of dermatology and other topical products for pharmaceutical and biotechnology clients, including early stage consultation. For additional information, please visit www.dowpharmsci.com.
David J. Cheng
Pacgen Biopharmaceuticals Corporation
Tel: (604) 436-4388
Fax: (604) 436-4380
Teresa M. Johnk
Dow Pharmaceutical Sciences