Therapeutic Experience

Through Fast2First, CNS has delivered expert services as a niche sector–provider to SME Biotech companies and over the last six years CNS has contributed to over 130 clinical trials for over 75 US (70%), European (15%) and Australian (15%) clients.
CNS combines broad therapeutic experience with our local network of specialist hospital groups and phase I units. This underpins our core capability of implementing and managing pivotal 1b/2a studies. Additionally, CNS has significant expertise in developing and managing Oncology, Respiratory, Immunology, Dermatology and Cardiovascular Devices (Drug–Eluting Stents) studies within Australia and New Zealand.

The following is a de-identified summary of CNS Therapeutic Experience, since 2005.

Click on the indication to open a full list of clinical trials run.

Addiction

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Single-Center, Dose-escalation Study of Oral Nicotine	1	18	Healthy Male Volunteers	Inhaled	Device	Aus

Analgesia

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
Bioequivalence and Pharmacokinetics / Pharmacodynamics of a Drug	1	14	Healthy Male Volunteers	IV	NCE	Aus
Pilot Study of Pain Blocking Therapy for Chronic Pain	1	10	Chronic and Intractible Pain	Intraoperatively	Device	Aus
A Single-Center, Dose Escalation Study of a Topical Anesthetic	1	24	Healthy Male Volunteers	Topical	NCE	Aus
Evaluation of the Pharmacokinetics of a Sublingual Drug	1	24	Healthy Volunteers	Sublingual	CE	Aus
A Crossover Evaluation of a Transdermal Formulation	1	6	Healthy Volunteers	Transdermal	CE	Aus
A Multi-Center Trial of a Subcutaneous Drug for Inadequately Controlled Cancer-Related Pain	3	120	Cancer-Related Pain	Subcutaneous Injection	CE	Aus & NZ

Autoimmune Disease

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
Photopheresis with a Device/Drug for the Prevention of Graft-versus-Host Disease in Patients Undergoing an Bone Marrow or 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
Evaluation of a Stent System for the Treatment of Coronary Artery Lesions	2	40	Coronary Lesion	Implantation	Device	Aus & NZ
Multi-Center Study to Evaluate The Efficacy and Safety of a Drug in Chronic Stable Angina Pectoris	2	60	Chronic Stable Angina Pectoris	Oral	Traditional Chinese Medicine	Aus & NZ
A Multi-Center Trial Investigating a Device For the Treatment of Aneurysms	2	150	Intracranial Saccular Aneurysm	Implantation	Device	Aus
A Multi-Center Trial to Assess a Coronary Stent System for the Treatment of Coronary Artery Lesions	2	100	Coronary Lesion	Implantation	Device	Aus & NZ
A Multi-Center Assessment of a Stent System Coronary Artery Lesions	2	40	Coronary Lesion	Implantation	Drug-eluting Stent	Aus & NZ

Cosmetic Surgery

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Pilot Study to Evaluate a Cosmetic Device in the Lysis of Subcutaneous Fat	1	30	Abdominoplasty	Subcutaneous Injection	Device	Aus

Dermatology

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Randomised Study to Evaluate a Drug in Patients with Uncomplicated, Gram-Positive Skin Infection	2a	8	Gram-Positive Skin Infection	Topical	CE	Aus
A Study to Evaluate a Cream in the Treatment of Atopic Dermatitis	1	36	Atopic Dermatitis	Topical	CE	Aus
A Study to Evaluate Topical Cream in Psoriasis	1	Protocol Design	Psoriasis	Topical

Endocrine

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
An Initial Human Study of Oral Hormone in Post-Menopausal Female Volunteers	1	18	Post- Menopausal Female Volunteers	Oral	Biological	Aus
A Dose-Finding Study of Bioavailability an Oral Formulation in women with Osteoporosis	2a	35	Female Osteoporosis	Oral	NCE	Aus
Single Dose Crossover Study of a Drug in Healthy Volunteers	1	48	Healthy Volunteers	Oral	NCE	Aus
A Comparison of an Inhaled Drug to Insulin	1	21	Healthy Volunteers	Inhaled	CE	Aus
A Study of Subcutaneous Drug in Patients with Type 2 Diabetes Mellitus	1a	55	Type 2 Diabetes	Subcutaneous Injection	CE	Aus

Gastroenterology

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Dose Escalation Study of a Biological Agent in Adults with Crohn’s Disease	1	12	Crohn’s Disease	Intravenous Infusion	Biological	Aus
Quantitative Assessment of Ostomy Pouches	4	10	Ostomy	Topical	Device	Aus

Infectious Disease

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Multi-Center Study of a Drug for the Treatment of Community Acquired Pneumonia	1	40	Community Acquired Pneumonia	IV	NCE	Aus
A Study of a Drug In Patients with Chronic HVC Infection	1b	28	HCV	Oral	NCE	Aus
A Multi-Center Study of a Drug in Patients with Chronic HCV Infection	1	38-48	HCV & Healthy Volunteers	Oral	Biological	NZ
A Multi-Center Study to Investigate the Oral Drug in Combination with Standard of Care in Treatment-Naïve Patients with Chronic HCV Infection	2	60	Chronic HCV	Oral	CE	NZ
A Study of an Immunostimulant Evaluating the Duration of the Immunologic Response	1	30	Healthy Elderly Volunteers	IM	Vaccine	Aus
Study to Evaluate Influenza Vaccination in Healthy Elderly Adults	1	50	Healthy Elderly Volunteers	Transcutaneous	Vaccine	Aus
Study of Vaccine against Plasmodium Falciparum	1	28	Healthy Volunteers	IM	Vaccine	Aus
A Study of a Vaccine against Plasmodium Falciparum	1	45	Healthy Volunteers	IM	Vaccine	Aus
A Multi-Center Study to Evaluate a Drug in the Treatment of Uncomplicated Influenza A	2	12	Influenza A	Oral	CE	Aus

Musculoskeletal

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Study of Test Product Versus Comparator in Cervical Dystonia	1	36	Healthy Volunteers	Injection	Biological	Aus

Neurology

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Trial of a Cell Therapy (GMO) in the Treatment of Patients With Stable Ischaemic Stroke	1	10	Ischaemic Stroke	Intracranial Implantation	Cell Therapy	Aus

Oncology

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
Single-Center Study Evaluating Cell Therapy in Patients with Pancreatic Carcinoma	1	10	Pancreatic Cancer	Interarterial	GMO	Aus
Multi-Center Study Evaluating Cell Therapy in Patients with Pancreatic Carcinoma	1	10	Inoperable Pancreatic Cancer	Intra-arterially by angiography	Biological	Aus
A Study Evaluating a Drug for the Attenuation of Mucositis in Patients Receiving Therapy for Head and/ or Neck Cancer	2	80	Head/Neck Cancer	Oral	NCE	Aus
Clinical Trial of Melanoma Vaccine in Patients with Stage IV Malignant Melanoma	1	9	Stage IV Melanoma	SC	Biological	Aus
Clinical Trial of a Drug in Metastatic Melanoma	2	36	Stage IV Melanoma	IV	NCE	Aus
Trial of a Drug in Relapsed Multiple Myeloma	1	45	Multiple Myeloma	IV	NCE	Aus
A Study of a Novel Diagnostic Test for the Detection of Urinary Tract Transitional Cell Carcinoma	1	125	Gross Macroscopic Haematuria	N/A	Diagnostic	Aus & NZ
Trial of the Safety and the Effect on Immune Parameters of an Immunotherapy for Glioma	1	10	Glioma	Intradermal	Biological	Aus
Clinical Evaluation of Immune Therapy of Dendritic Cells with Drug in Stage IV Metastatic Melanoma	1	31	Stage IV Melanoma	IV/ Intradermal	Biological	Aus
A Trial of a Vaccine for Hormone-Refractory Prostate Cancer	1	30	Prostate Cancer	IV	Biological	Aus
Trial of an Immunotherapy for Stage III Melanoma with Cultured Cells	3	200	Stage III Melanoma	Intradermal	Biological	Aus & NZ
Trial to Assess a Cell Therapy in Patients with Stage III or IV Nasopharyngeal Carcinoma	1	10	Nasopharygeal Carcinoma	IV Infusion	Cell Therapy	Aus
T Cells Therapy for Relapsed / Refractory Lymphomas	1	20	Lymphoma	IV	Biological	Aus
Study of Photoimmune Therapy with a Device/Drug in Patients with Chronic Graft-versus-Host Disease	2	24	GvHD	IV	Drug/Device	Aus
An Extension Study of an Extracorporeal Photoimmune Study of Photoimmune Therapy with a Device/Drug in Patients with Chronic Graft-versus-Host Disease	2	18	GvHD	IV	Drug/Device	Aus
A PK Study of a new Compound in Healthy Male Subjects	1	48	Healthy Male Volunteers	IV	Biological	Aus
A Multi-Center Study of an Intravenous Formulation as Monotherapy in Subjects with Hepatic Tumor Burden	1b/2	63	Metastatic Hepatic Tumour	IV	NCE	Aus
Intratumoural Treatment of Squamous Cell Carcinoma of the Head and Neck	1	9	Head and Neck Cancer	Intratumourally	Biological	Aus
Trial to Assess Safety of Autologous T Cell Therapy For Glioblastoma Multiforme	1	10	Recurrent Glioblastoma	IV	Biological	Aus
Adoptive Immunotherapy for Epstein-Barr Virus Associated Nasopharyngeal Carcinoma	1	50	Stage 1 - 4 NPC	Intravenous Injection	Biological	Aus
Immunotherapy for Treatment of Human Cytomegalovirus (HCMV) following Stem Cell Transplantation	1	40	Allogeneic HSCT Recipients and Donors	Intravenous Infusion	Biological	Aus

Ophthalmology

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Trial of Intravitreous Drug in Combination with Therapy in Subjects with Neovascular Age-Related Macular Degeneration	1	36	Neovascular Age-Related Macular Degeneration	Intravitreous	Biological	Aus & NZ
A Study of Safety of Intravitreous Injections of Drugs Given in Combination in Subjects With Neovascular Age-Related Macular Degeneration	1	40	Neovascular Age-Related Macular Degeneration	Intravitreous	Biological	Aus

Orthopaedic

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Multi-Center Study Evaluating a Device in Subjects With Degenerative Disc Disease	1	10	Lumbar Fusion	Implantation	Device	Aus
Multi-Centre Study of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease	4	142	Degenerative Disc Disease	Surgical	Device	Aus

Parasitic

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
An Escalating Dose Study of a Topical Application to the Hair and Scalp of Healthy Volunteers	1	32	Healthy Volunteers	Topical	NCE	Aus

Renal

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Study of the Effects of Therapeutic Gas in Patients Receiving Kidney Transplants	2	40	Renal Transplants	Inhaled	CE	Aus & NZ

Respiratory

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Dose-Escalation Study to Evaluate an Inhaled drug in Healthy Adult Subjects	1	20	Healthy Volunteers	Inhaled	CE	Aus
A Multi-Center Study of Effect on Sputum Pseudomonas Aeruginosa of an Inhaled Drug in Cystic Fibrosis	2a	24	Adult Cystic Fibrosis	Inhaled	CE	Aus & NZ
A Study Investigating the Tolerability and Pharmacokinetics of an Aerosol	1	16	Healthy Volunteers	Inhaled	CE	Aus
A Multi-Center Study of Effect on Sputum Pseudomonas Aeruginosa of an Inhaled Drug in Cystic Fibrosis	2a	24	Adult Asthmatic	Inhaled	CE	Aus
A Study Evaluating Tidal Breathing and Inspiratory Flow Parameters of Healthy and Asthmatic Children	0	N/A	Paediatric Asthmatic	Inhaled	Device	Aus
A Multi-Centre Study Evaluating Administration of Drug in Patients with COPD	1/2a	25	Chronic Obstructive Airways Disease	Inhaled	CE + Device	Aus & NZ
A Cross-Over Study of Inhaled Products in Adults with non-CF Bronchiectasis	2	15	Healthy Volunteers & Bronchiectasis	Inhaled	CE	Aus
A Multi-Center Study to Evaluate an Aerosol in Patients with Non-Cystic Fibrosis Bronchiectasis	2a	40	Non-CF Bronchiectasis	Respiratory	CE	Aus & NZ
A Multi-Center, Dose Escalating Study of Therapeutic Gas for Inhalation in Adults with Cystic Fibrosis	2	104	Adult Cystic Fibrosis	Inhaled	CE	Aus
A Single-Center Study Evaluating a Administration of Inhaled Treatments in Healthy Subjects	1	16	Healthy Volunteers	Inhaled	CE	Aus
A Study Evaluating the Inhalation Profiles of Asthmatic Children using various Inhaler Designs	0	70	Children with Asthma	N/A	N/A	Aus
A Multi-Centre Comparison of a Drug and Comparator in Patients with COPD	2	42	COPD	Inhaled	CE	Aus & NZ
A Multi-Center Study of an Aerosol in the Management of Pseudomonas Aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis	2b	96	Non-CF Bronchiectasis	Inhaled	CE	Aus

Sleep Disorder

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Study of the Safety, Tolerability, and Pharmacokinetics of an Oral drug in Healthy Adult Subjects	1	16	Healthy Volunteers	Oral	Biological	Aus

Transplant

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
A Multi-Center Study of a Biological in Acute Pulmonary Allograft Rejection	3	24	Lung Transplant	IV	Biological	Aus
A Multi-Center Study of Drug for Chronic Allograft Injury in Renal Transplant Recipients	3	84	Adult Renal Transplant Recipients	Oral	CE	Aus & NZ

Urology

Description	Phase	Target no. of Subjects	Population	Route of Administration	Compound Type	Territory
Study of a Drug in Bladder Symptoms Assessment	3b/4	48	Overactive Bladder	Oral	CE	Aus
A Study of Drug in Neurogenic Detrusor Overactivity	3b/4	24	Neurogenic Detrusor Overactivity	Oral	CE	Aus
Effects of Combinations on Pharmacokinetics of a Drug in Healthy Subjects	1	18	Healthy Males	Oral	CE	Aus