Experience

Trainer

CNS has worked with over 65 clients, mainly SMEs and several of the current top 10 Pharma and Biotech companies since 2003. Of this number over 50% are US companies, 30% Australian and 20% Europe/Asia. Furthermore, over 90% of our clients have worked with CNS on more than one study and on occasion throughout their product’s early phase development.

The following is a de-identified summary of CNS Therapeutic Experience: since 2005
Addiction

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
A Single-centre, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Nicotine Administered via new route in Healthy Adult Male Smokers	1	18	Healthy Male Volunteers	Inhaled	Device	Aus

Analgesia

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
A Prospective, Double-Blind, Randomized, Bioequivalence Trial in Normal Volunteers to Compare the Pharmacokinetics and Pharmacodynamics of Drug with Propofol	1	14	Healthy Male Volunteers	IV	NCE	Aus
Pilot Study of Pain Blocking Therapy for the Treatment of Chronic Pain	1	10	Chronic and Intractible Pain	Intraoperatively	Device	Aus
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo- Controlled Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Topical Application of an Anesthetic in Healthy Male Volunteers	1	24	Healthy Male Volunteers	Topical	NCE	Aus

Autoimmune Disease

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
A Study of Extracorporeal Photopheresis with a evice/Drug in the Setting of a Standard Myeloablative Conditioning Regimen for the Prevention of Graft-versus-Host Disease in Patients Undergoing an Allogenic Bone Marrow Transplant or Peripheral Blood Stem Cell Transplant	2	12	Rheumatoid Arthitis	IV	Drug/Device	Aus

Cardiology

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
A Prospective Evaluation in a Randomized Trial of the Safety and Effi cacy of the Use of a New Stent System for the Treatment of De Novo Coronary Artery Lesions	2	40	Coronary Lesion	Implantation	Device	Aus & NZ
A Randomized, Multi-Centre, Single-Blind Comparison of a New Stent System with Sirolimus Elution versus the TAXUS® Libertè™ Paclitaxeleluting Coronary Stent System in De Novo Native Coronary Artery Lesions	2	40	Coronary Lesion	Implantation	Device	Aus & NZ
A Phase II, Double Blind, Placebo-controlled, Randomized, Multi-Center, Parallel Group Study to Evaluate the Effi cacy and Safety of a Drug in Patients with Chronic Stable Angina Pectoris	2	60	Chronic Stable Angina Pectoris	Oral	Traditional Chinease Medicine	Aus & NZ

Cosmetic Surgery

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
Clinical Trial to Evaluate the Safety and Feasibility of Cosmetic Device System in the Minimally Invasive Lysis of Shallow Subcutaneous Fat – A Pilot Study	1	30	Abdominoplasty	Subcutaneous Injection	Device	Aus

Endocrine

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
An Initial Human Study with Placebo and Positive Control, to Determine the Safety and Tolerability of 2 Pharmaceutical Forms of Oral Hormone in Post-Menopausal Female Volunteers	1	18	Post- Menopausal Female Volunteers	Oral	Biological	Aus
A Dose Finding Phase 2a Clinical Study, to Determine the Bioavailability of Doses of a Pharmaceutical Form of a Drug Compared to (Injectable/ Nasal) Calcitonin in Females Diagnosed With Osteoporosis	2a	35	Female Osteoporosis	Oral	NCE	Aus
Single Dose Crossover Comparative Pharmacodynamic Study of a Drug in Healthy Male and Female Volunteers	1	48	Healthy Volunteers	Oral	NCE	Aus
A Two Part Insulin Pharmacokinetic and Glucose Pharmacodynamic Comparison of Inhaled Drug to a Rapid Acting Insulin Analog by Subcutaneous Injection in Healthy Subjects	1	21	Healthy Volunteers	Inhaled	CE	Aus

Gastroenterology

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
A Placebo-Controlled Phase I Single and Multiple IV Dose Escalation Study of Safety, Pharmacokinetics, Pharmacodynamics and Immunogenicity of a Biological Agent in Adults with Crohn’s Disease	1	12	Crohn’s Disease	Intravenous Infusion	Biological	Aus
Quantitative Assessment of New Ostomy Pouches Against the Currently Marketed Soft-Flex Barrier Using Ostomate Volunteers	4	10	Ostomy	Topical	Device	Aus

Infectious Disease

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
A Randomized, Double-Blind, Parallel Group, Multicenter Study of a Drug versus Telithromycin for the Treatment of Community Acquired Pneumonia	1	40	Community Acquired Pneumonia	IV	NCE	Aus
A Phase I, Single Centre, Double Blind, Randomised, Placebo Controlled, Single Escalating Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of a Drug Administered Topically to the Hair and Scalp of Healthy Volunteers	1	32	Healthy Volunteers	Topical	NCE	Aus
A Phase 1b Study of a Drug In Patients with Chronic HCV Infection	1b	28	HCV	Oral	NCE	Aus
A Multiple-Center, Observer-Blinded, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Food Effect of a Drug in Healthy Volunteers and in Patients with Chronic HCV Infection of Genotype I	1	38-48	HCV	Oral	Biological	NZ

Neurology

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of an Oral Drug Under Fasted Condition in Healthy Adult Subjects	1	16	Healthy Volunteers	Oral	Biological	Aus
A Phase l Safety Trial of a Cell Therapy (GMO) delivered Intracranially in the Treatment of Patients with Stable Ischaemic Stroke	1	12	Ischaemic Stroke	Intracranial Implantation	Cell Therapy	Aus

Oncology

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
Single arm, single-centre, open label Phase I clinical study evaluating the safety and tolerability of a Cell Therapy (GMO) in patients with inoperable pancreatic carcinoma	1	10	Pancreatic Cancer	Interarterial	GMO	Aus
A Phase II Double-blind Placebo-controlled Randomised Study Evaluating the Effi cacy and Safety of a Drug for the Attenuation of Oropharyngeal Mucositis in Patients Receiving Radiotherapy or Chemoradiotherapy for the Treatment of Head and/ or Neck Cancer	2	80	Head/Neck Cancer	Oral	NCE	Aus
Phase I Clinical Trial of Melanoma Cell Vaccine in Patients with Stage IV Malignant Melanoma	1	9	Stage IV Melanoma	SC	Biological	Aus
Phase II Clinical Trial of a Drug in Metastatic Melanoma	2	36	Stage IV Melanoma	IV	NCE	Aus
Phase 1 Clinical Trial of a Drug in Relapsed and Relapsed Refractory Multiple Myeloma	1	45	Multiple Myeloma	IV	NCE	Aus
A Prospective Study of a Novel Urine Diagnostic Test for the detection of Urinary Tract Transitional Cell Carcinoma (TCC)	1	125	Gross Macroscopic Haematuria	N/A	Diagnostic	Aus & NZ
Phase I Trial of the Safety and the Effect on Immune Parameters of an Immunotherapy for Glioma	1	10	Glioma	Intradermal	Biological	Aus
Phase I Clinical Evaluation of Immune Therapy with Dendritic Cells Pulsed with Drug in Stage IV Metastatic Melanoma	1	31	Stage IV Melanoma	IV/ Intradermal	Biological	Aus
A Phase I Trial of a Vaccine for Hormone-Refractory Prostate Cancer	1	30	Prostate Cancer	IV	Biological	Aus
Phase III Trial of an Immunotherapy for Stage III (AJCC) Melanoma Based on Cultured Cells	3	200	Stage III Melanoma	Intradermal	Biological	Aus & NZ
Phase I trial to assess the safety of adoptive transfer of a Cell Therapy in patients with Stage III or IV Nasopharyngeal Carcinoma	1	10	Nasopharygeal Carcinoma	IV Infusion	Cell Therapy	Aus
A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy with a Device/Drug in Conjunction with Standard Therapy Alone for the Treatment of Patients with Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graftverus- Host Disease	2	24	GvHD	IV	Drug/Device	Aus
An Extension Study of an Extracorporeal Photoimmune Therapy with a Device/Drug in Conjunction with Standard Therapy for the Treatment of Patients with Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-verus-Host Disease	2	18	GvHD	IV	Drug/Device	Aus
A Phase 1, Double-Blind, Placebo-Controlled, Single-Ascending Dose, Safety, Tolerance, and Pharmacokinetic Study of a Drug in Healthy Male Subjects	1	48	Healthy Male Volunteers	IV	Biological	Aus

Ophthamology

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
A Phase 1, Ascending Dose and Parallel Group Trial to Establish the Safety, Tolerability and Pharmacokinetic Profi le of Intravitreous Injections of a Drug Given in Combination With LUCENTIS® 0.5 mg/eye in Subjects with Neovascular Age-Related Macular Degeneration	1	36	Neovascular Age-Related Macular Degeneration	Intravitreous	Biological	Aus & NZ
A Phase 1 Ascending Dose and Parallel Group Trial to Establish the Safety, Tolerability and Pharmacokinetic Profi le of Multiple Intravitreous Injections of a Drug Given Either in Combination Therapy with Multiple Doses of LUCENTIS® 0.5 mg/eye, or with One Induction Dose of LUCENTIS® 0.5 mg/eye in Subjects with Neovascular Age-Related Macular Degeneration	1	40	Neovascular Age-Related Macular Degeneration	Intravitreous	Biological	Aus

Respiratory

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
An Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of an Inhaled Antibiotic in Healthy Adult Subjects	1	20	Healthy Volunteers	Inhaled	CE	Aus
A Multicenter, Open-Label, Single-Arm, Proof-Of-Concept Study to Evaluate the Safety, Tolerability, and Effect on Sputum Pseudomonas Aeruginosa Density of an Inhaled Antibiotic in Adult Patients with Cystic Fibrosis	2a	24	Adult Cystic Fibrosis	Inhaled	CE	Aus & NZ
A Randomized, Double Blind, Active Controlled, Single Dose, 4 Arm, 4 Period Crossover, Phase 1 Study Investigating the Tolerability and Pharmacokinetics of a Low Dose Drug	1	16	Healthy Volunteers	Inhaled	CE	Aus
A Randomized, Open-Label, 3 Single Dose, Safety and Dose Response Study Investigating the Pharmacokinetics and Pharmacodynamics of an Inhaled Drug in Adult Asthmatic Subjects	2a	24	Adult Asthmatic	Inhaled	CE	Aus
An Observational Study Evaluating Tidal Breathing and Inspiratory Flow Parameters of Healthy and Mild-to-Moderate Asthmatic Children Aged 2-6 Years	0	80	Paediatric Asthmatic	Inhaled	Device	Aus
An Observational Study Evaluating the Inhalation Profi les of Mild-to- Moderate Asthmatic Children Aged 3 to 11 Years Using Five Novel, Proprietary Breath-Actuated Pressurized Metered-Dose (pmdi) Inhaler Designs	0	70	Paediatric Asthmatic	Inhaled	Device	Aus
A Randomized, Double-blind, Five-period, Placebo and Activecontrolled, Cross-over, Multi-centre, Study Evaluating Single Administration of Three Doses of Drug MDI in Patients with Moderateto- Severe COPD, Compared to Open-Label Marketed Formoterol (FORADIL® AEROLIZER®) as an Active Control	1/2a	25	Chronic Obstructive Airways Disease	Inhaled	CE + Device	Aus & NZ

Transplant

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
A Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study of a Biological in the Prophylaxis of Acute Pulmonary Allograft Rejection in Adult Recipients of Primary Pulmonary Allograft(s)	3	24	Lung Transplant	IV	Biological	Aus

Urology

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
Phase IIIb/IV Study of a Drug in a Flexible Dose Regimen With Simplifi ed Bladder Training Versus the Drug in a Flexible Dose Regimen Alone in a Prospective, Randomized, Parallel Group, Overactive Bladder Symptom Study	3b/4	48	Overactive Bladder	Oral	CE	Aus
A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Effi cacy and Safety of a Drug (5 and 10mg once daily) against Placebo and Oxybutynin Hydrochloride (5 mg three times daily) in the Treatment of Subjects with Neurogenic Detrusor Overactivity	3b/4	24	Neurogenic Detrusor Overactivity	Oral	CE	Aus

Vaccine

Description	Phase	Target No. of Subjects	Population	Route of Administration	Compound Type	Territory
A Randomized, Double-blind, Placebo-controlled Study of the Dosaging of an Immunostimulant in Conjunction with Infl uenza Vaccination (Stage I), with a Nine Month (Stage II) Observation Period Evaluating the Duration of the Immunologic Response	1	30	Elderly Healthy Volunteers	IM	Biological	Aus
Phase I Open Label Study to Evaluate the Safety and Immunogenicity of Intramuscular and Intradermal Infl uenza Vaccination and Transcutaneous Adjuvant Administration with a Biological Agent in Healthy Elderly Adults	1	50	Healthy Elderly Adults	Transcutaneous	Biological	Aus
Phase 1 Study of the Safety, Reactogenicity and Immunogenicity of Vaccine: A Blood Stage Vaccine for Plasmodium falciparum	1	28	Healthy Volunteers	IM	Biological	Aus
A Phase 1, Randomised, Double Blinded Within Dose, Placebo Controlled, Dose-Escalation, Safety and Immunogenicity Study of a Blood-Stage Vaccine against Plasmodium Falciparum in Healthy Volunteers	1	45	Healthy Volunteers	IM	Biological	Aus