Coley Pharmaceutical Group, Inc. is a biopharmaceutical company focused on discovering and developing a class of drug candidates for cancers, infectious diseases and respiratory disorders. The Company's TLR Therapeutics act on a specific class of targets, called toll-like receptors (TLRs), found in and on immune system cells, which in turn, direct the immune system to fight disease. Coley and its collaborators have four drug candidates in clinical trials, including its lead product candidate, ProMune (CPG 7909 Injection, which is referred to as PF-3512676 by its partner Pfizer Inc.) for cancers and Actilon (CPG 10101) for infectious diseases, particularly chronic Hepatitis C Virus (HCV). The Company's drug candidates in clinical trials target a specific TLR known as TLR9. Coley has also entered into collaborations with sanofi-aventis, GlaxoSmithKline and Chiron Corporation to develop respiratory disease treatments and vaccine adjuvants. TLR Therapeutics Coley has focused its development efforts primarily on compounds targeting one specific TLR, known as Toll-like receptor 9 (TLR9), for the treatment of cancers, infectious diseases and asthma and allergy. TLR9 is found in certain human immune cells, known as plasmacytoid dendritic cells and B cells. TLR9 functions to detect a pattern that is present in the deoxyribonucleic acid (DNA) of invading intracellular pathogens, but is not present in the body's own DNA. When TLR9 detects this pattern, which is called a CpG motif, it triggers a Th1 response. The TLR Therapeutics are synthetic compounds that function as agonists, or stimulators, or as antagonists, or blockers, of one or more TLRs that are found in immune cells. TLR Therapeutics in clinical development are agonists of TLR9, and they stimulate a Th1 type of immune response. Coley's TLR9 agonists are synthetic oligodeoxynucleotides, comprising short, DNA-like molecules, or oligonucleotides which mimic the CpG motifs found in some pathogens, thereby triggering the body's immune response. Unlike antisense or gene therapy oligonucleotides, the sequences of TLR9 agonists are not present in the human genome so they should avoid the negative genetic side effects that have limited these other therapeutic approaches. Furthermore, the TLR Therapeutics are generally designed to be administered once weekly by subcutaneous injection with relatively low concentrations providing the intended therapeutic effect. ProMune/PF-3512676 for Cancer In March 2005, Coley entered into a series of related agreements with Pfizer under which it granted Pfizer development and worldwide marketing rights to ProMune for the treatment, control and prevention of multiple cancer indications, including non-small cell lung cancer (NSCLC) and breast cancer. Prior to licensing ProMune to Pfizer, Coley conducted 10 oncology clinical studies of this product candidate in hematologic and solid tumors. These studies were in NSCLC, melanoma, recurrent Cutaneous T-Cell Lymphoma (CTCL), renal cell carcinoma, non-Hodgkin's lymphoma, refractory breast cancer and basal cell carcinoma, and evaluated ProMune as a single agent, in combination with chemotherapy and in combination with monoclonal antibodies. In November 2005, Pfizer initiated two pivotal international Phase III clinical trials in first-line treatment of advanced NSCLC under the Special Protocol Assessment procedure of the United States Food and Drug Administration (FDA). Actilon and Infectious Diseases Program Actilon is a synthetic oligodeoxynucleotide and a selective TLR9 agonist, which strongly activates interferon production by the plasmacytoid dendritic cells and enhances their ability to activate killer T cells against invaders. Coley has undertaken four randomized, controlled studies with Actilon, involving over 150 subjects. The first two studies have been completed. The two other studies are designed to determine the safety, tolerability and ability of Actilon to induce antiviral response alone or in combinations with the standard of care in two difficult to treat patient pop