Metabolic Pharmaceuticals's Neuropathic Pain Drug, ACV1, Enters Phase 2 Clinical Trials

MELBOURNE, Australia, Sept. 28 /PRNewswire-FirstCall/ -- Metabolic Pharmaceuticals announced today that ethics approval has been obtained for the first of two Phase 2A human clinical trials on ACV1, for the treatment for neuropathic pain. Recruitment of 40 patients into this trial has now commenced.

This study, the first of two Phase 2A trials designed to investigate the safety and efficacy of ACV1, will examine the effects of the drug in patients with neuropathic sciatic pain. Sciatica is a chronic pain condition caused by damage to the sciatic nerve, the nerve that travels from the spinal cord to the leg, which can be pinched and damaged by the vertebrae at the point the sciatic nerve leaves the spinal cord. Sciatica manifests as lower back pain or pain in the hip and/or leg and may lead to weakness and poor function of the leg muscles.

Metabolic expects to have the results of this trial available during the first six months of 2007 (H107).

Q306 First trial in the Phase 2A programme for ACV1 begins for treatment of sciatica Q107 Second trial in the Phase 2A programme for ACV1 begins for treatment of diabetic neuropathic pain (chronic pain caused by diabetes- related nerve damage) and post-herpetic neuralgia (chronic pain developing after a bout of shingles) H107 Results of the first trial in the Phase 2A program for ACV1 expected to be announced Trial 1 of 2: Neuropathic sciatic pain - trial design

The study will include 40 patients, both male and female, who will be treated with 0.4 mg/kg of ACV1 and placebo by subcutaneous injection once per day, in a cross-over design.

This trial is being carried out at one site, the Pain and Anaesthesia Research Clinic (PARC) at the Royal Adelaide Hospital, South Australia, and will be conducted in accordance with the Principles of the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP).

Further details regarding the design of this trial are provided in the Appendix to this announcement.

Trial 2 of 2: Diabetic neuropathic pain and post-herpetic neuralgia

The second Phase 2A trial in this programme will target diabetic neuropathic pain and post-herpetic neuralgia and is anticipated to commence during the January-to-March 2007 quarter (Q107). Diabetic neuropathy is a chronic pain condition that results from damage to nerves throughout the body caused over time by diabetes. Post-herpetic neuralgia pain occurs in approximately 20 percent of people diagnosed with shingles and is a chronic pain condition that results from nerve damage caused by the herpes zoster virus.

Background to ACV1 and neuropathic pain - ACV1 was safe and well tolerated at all administered doses in the first human study (Phase 1 trial) for the drug, completed in November 2005. - ACV1 has been tested in several well-established animal pain models and shows efficacy in relieving the characteristic pain symptoms of neuropathy, allodynia and hyperalgesia. - ACV1 is a 16 amino acid peptide conotoxin derived from an Australian cone snail. The drug works by blocking a subtype of a class of receptors in the peripheral nervous system call neuronal nicotinic acetylcholine receptors (nAChR). - Neuropathic pain is the most debilitating form of chronic pain, generated from damaged nerves and serving no beneficial function for the affected individual. Besides diabetes, the common causes of neuropathy are viral infection (e.g. shingles), trauma, sciatica, chemotherapy and various other conditions. - Neuropathic pain affects 10 million people in the US alone. The current market for neuropathic pain drugs is valued at approximately US$2.5 billion a year and is expected to double in five years. Appendix: Trial design for ACV1 for sciatic neuropathic pain Phase of development Phase 2A human clinical trial Patient populations Patients with sciatic neuropathic pain Patient selection Males, and females of non-childbearing criteria potential, aged 18 to 65 years inclusive, with a history of at least three months of moderate to severe neuropathic sciatic pain. Number of patients * 20 per treatment group; crossed over * Total of 40 Study centre Pain and Anaesthesia Research Clinic (PARC), Royal Adelaide Hospital, South Australia Investigators Principal Investigator: Prof Guy Ludbrook, Professor and Head of Anaesthesia, Dept Anaesthesia and Intensive Care, University of Adelaide and Royal Adelaide Hospital (Principal Investigator on ACV1 Phase 1 study) Co-Investigator: Dr Paul Rolan, Professor Clinical Pharmacology, Dept Clinical & Experimental Pharmacology, University of Adelaide Aims To determine the safety and tolerability of ACV1 in patients with neuropathic sciatic pain, and the pharmacodynamic effects and pharmacokinetics of ACV1 following single and multiple subcutaneous doses. Doses ACV1 dose and placebo * 0.4 mg/kg via subcutaneous injection once per day Design Randomised, double blind, placebo-controlled, cross-over design (all patients will spend some time on ACV1 and some time on placebo). Duration 7 days, one week washout Efficacy endpoints Study is exploratory in nature, and not powered for analgesia, but pain will be assessed in patients by Visual Analogue Scales and appropriate questionnaires. Pharmacodynamic measures will include von Frey testing and thermal Quantitative Sensory Testing. About Metabolic

Metabolic Pharmaceuticals Limited is a Melbourne based, ASX listed biotechnology company with 285 million shares on issue. The Company employs 24 staff and is led by an experienced and proven management team. Metabolic's main focus is to take innovative drugs, with large market potential, through formal preclinical and clinical development. Metabolic's expertise in drug development has resulted in two high value drugs in advanced human clinical development, namely:

- AOD9604 - an obesity drug currently in a Phase 2B trial with results expected in March 2007; - AOD9604 - additional use in osteoporosis with a Phase 2 trial expected to commence in 2007; and - ACV1 - a neuropathic pain drug currently in Phase 2A trials.

These drugs address multi-billion dollar markets which are poorly served by existing treatments. In addition to its lead drugs, Metabolic has an exciting research pipeline with drugs targeting type 2 diabetes (ADD) and nerve regeneration (NRPs). Metabolic is also developing a platform to enable oral delivery of existing injected peptide drugs, a technology which has already shown proof-of-concept. This has high potential for use by other companies developing peptide drugs and could foster multiple out-licensing deals.

Metabolic plans to license its lead drugs to a global partner following Phase 2 trials and will continue to utilise its clinical development expertise to drive future company growth and profits

For more information, please visit the company's website atwww.metabolic.com.au.

Background information on the drug development process The steps required before a drug candidate is commercialised include: 1. Discovery or invention, then filing a patent application in Australia and worldwide; 2. Pre-clinical testing, laboratory and chemical process development and formulation studies; 3. Controlled human clinical trials to establish the safety and efficacy of the drug for its intended use; 4. Regulatory approval from the Therapeutic Goods Association (TGA) in Australia, the FDA in the USA and other agencies throughout the world; and 5. Marketing and sales.

The testing and approval process requires substantial time, effort, and financial resources and we cannot be certain that any approvals for any of our products will be granted on a timely basis, if at all.

Human clinical trials are typically conducted in three sequential phases which may overlap: Phase 1 Phase 2 Phase 3 Initial safety Studies in a limited patient Trials undertaken to study in healthy population designed to: further evaluate human subjects or - identify possible adverse dosage and clinical patients. effects and safety risks in efficacy and to the patient population further test for (2A); safety in an expanded - determine the efficacy of the patient population in Phase 1 trials product for specific targeted clinical study sites usually run for a diseases (2B); and throughout major short duration. - determine tolerance and target markets (e.g. optimal USA, Europe and dosage (2B). Australia). Contact Information Roland Scollay Peter Dawson Chief Executive Officer Chief Financial Officer roland.scollay@metabolic.com.aupeter.dawson@metabolic.com T: +61-3-9860-5700 T: +61-3-9860-5700 Diana Attana Assistant Company Secretary/IRO diana.attana@metabolic.com.au T: +61-3-9860-5700

Metabolic Pharmaceuticals Ltd.

CONTACT: Roland Scollay, Chief Executive Officer, +61-3-9860-5700,roland.scollay@metabolic.com.au, Peter Dawson, Chief Financial Officer,+61-3-9860-5700, peter.dawson@metabolic.com.au, or Diana Attana, AssistantCompany Secretary/IRO, +61-3-9860-5700, diana.attana@metabolic.com.au, allof Metabolic Pharmaceuticals