Drug Pipeline Series: Phase I, Oct23-Oct30, 2006

EPIX Pharmaceuticals Initiates Phase 1 Multiple Ascending Dose Clinical Trial of PRX-07034 in Obesity
EPIX Pharmaceuticals, Inc. announced the initiation of a Phase 1 multiple ascending dose clinical trial to study the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-07034 administered once-daily for 28 days in a population of otherwise healthy obese adults with body mass indices between 30 and 42 kg/m(squared). PRX-07034 is a novel, highly selective 5-HT6 receptor antagonist being developed for the treatment of obesity, as well as for cognitive impairment associated with Alzheimer's Disease and schizophrenia.
PRX-07034 is a novel, highly selective, small-molecule antagonist of a specific G-protein coupled receptor (GPCR) known as 5-HT6. Preliminary safety and tolerability data from a recently completed single ascending dose Phase 1 trial in healthy adult male and female volunteers indicated that single doses of PRX-07034 were well-tolerated up to 2500 mg, the highest dose tested. In addition, PRX-07034 demonstrated adequate absorption, with drug exposures increasing with increasing doses and a half-life of 14 to 24 hours, making it suitable for once-daily dosing.

Metabasis Therapeutics Initiates a Phase 1 Clinical Trial of MB07811, a Novel Product Candidate for Reducing Both LDL-Cholesterol and Triglycerides
Metabasis Therapeutics, Inc. announced that it has initiated a Phase 1 clinical trial of MB07811, a novel, orally active product candidate for the management of hyperlipidemia, or elevated cholesterol. MB07811, Metabasis' fifth internally discovered product candidate to enter human clinical trials, uses the Company's proprietary HepDirect® prodrug technology to target a beta-subtype-selective thyroid hormone receptor (TRB) agonist to the liver to reduce serum cholesterol (LDL) and triglycerides (TGs). The Company believes that this drug class has the potential to be additive to the class of hyperlipidemia drugs known as "statins", and preclinical data suggests that MB07811 could be as effective at lowering serum cholesterol as this important drug class. Statins represent a drug class commonly used to treat hyperlipidemia and at present comprise the single largest pharmaceutical market in the world, growing by over 15% per year.
The study initiated will evaluate the safety and tolerability of MB07811 in a rising single dose study in healthy volunteers. Assuming the successful completion of additional preclinical trials and the recently initiated Phase 1 single dose trial, the Company expects to pursue further clinical studies, including a multiple dose Phase 1 study in healthy volunteers.

INNOVIVE Pharmaceuticals Begins Enrollment in Phase I Study of INNO-305 Peptide Immunotherapy in AML, MDS, Mesothelioma and Non-Small Cell Lung Cancer
INNOVIVE Pharmaceuticals, Inc. announced that a Phase I clinical trial investigating INNO-305 in acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), mesothelioma and non-small cell lung cancer (NSCLC) has enrolled its first patient. The trial is being conducted by Lee Krug, M.D., of the Thoracic Oncology Service, and Peter Maslak, M.D., of the Leukemia Service at Memorial Sloan Kettering Cancer Center in New York.
The study is an open label fixed dose trial and will study the safety, tolerability, pharmacokinetics and preliminary efficacy of INNO-305. The vaccine will be tested in patients with hematologic malignancies and solid tumors for which there is evidence of WT1 expression.
INNO-305, a WT1 peptide therapeutic vaccine, is unique among WT1 peptide immunotherapies because of its ability to stimulate both CD8 and CD4 T-cells. It is believed that stimulating both types of T-cells may result in a more robust and ubiquitous immune response. As an added measure, INNO-305 utilizes an approach in which the wild-type WT1 peptide sequences are altered to improve the ability of the drug to activate T-cells.

Anesiva Starts Phase 1 Clinical Study of 1207, New Topical Local Anesthetic
Anesiva, Inc. announced that it has commenced Phase 1 clinical testing of product candidate 1207, a new topical local anesthetic for the potential treatment of numerous pain conditions, including neuropathic pain.
The study, designed to assess the safety of 1207, will enroll 24 adult healthy male volunteers in up to six dose-escalating cohorts in Australia. In addition to safety data, the randomized, double-blind, placebo-controlled study will measure sensory perceptions of touch and warmth following a single topical administration of 1207 compared with placebo.
1207 is a new chemical entity with novel anesthetic properties that provide pain relief by binding to the fast sodium channel on neurons responsible for transmitting pain signals from nerve endings to the brain. Specifically, 1207 binds to the fast sodium channel on both A nerve fibers responsible for transmitting immediate "adaptive pain" signals and C nerve fibers responsible for transmitting longer-term, dull, aching throbbing pain signals. By interrupting the communication channel of both A fibers and C fibers, 1207 is designed to provide effective topical pain relief with a faster onset and longer duration of action than currently marketed pain products. In preclinical testing, topical administration of 1207 demonstrated a long duration of action and deep, rapid penetration. Other potential applications for 1207 include pre-procedural use in dermatological surgery and post-surgical incision pain.

Tanox Initiates Phase 1 Clinical Trial Evaluating TNX-650 for Treatment of Asthma
Tanox, Inc. has begun dosing a Phase 1 clinical trial of TNX-650, a humanized monoclonal antibody being evaluated as a potential treatment for moderate-to-severe asthma.
The trial is a randomized, double-blind, placebo-controlled, dose- escalation study of the safety, tolerability and pharmacokinetics of single doses of TNX-650 in healthy volunteers. A total of 32 subjects will be enrolled in four cohorts in the study, which is being conducted at a single site in the U.S.
TNX-650 targets Interleukin 13 (IL-13). Preclinical studies indicate that IL-13 is a key mediator of asthma responses, including airway inflammation, obstruction and hyper-reactivity. TNX-650, which has a mechanism of action unique from currently available asthma treatments, has the potential to be a therapeutic option for patients whose disease is not currently well controlled and for non-allergic asthmatics.