Southern Star Research Pty Ltd. is a clinical research organization based in Gordon, Australia. The company specializes in providing services for biotechnology, pharmaceutical, and medical device clinical trials.

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Drugs associated with Southern Star Research Pty Ltd.

MMV367

Target-

Mechanism-

Active Org.

ICON plc [+4]

Originator Org.

MMV Medicines for Malaria Venture

Active Indication

Parasitemia [+1]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

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Clinical Trials associated with Southern Star Research Pty Ltd.

NCT06263270 / Not yet recruitingPhase 1

A Phase Ia, Multicenter, Double-Blind, Placebo-controlled Study to Evaluate the Safety of CYT-108 for the Therapy of Mild to Moderate Primary Osteoarthritis of the Knee

The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are:
are two doses of CYT-108, delivered 12 weeks apart, safe when injected directly into the joint?
does administration of CYT-108 result in a reduction in pain, stiffness, and improvement in daily physical function?
Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify "disease modification" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment.

Start Date01 Jun 2024

Sponsor / Collaborator

Cytonics Corp.

[+1]

NCT05994664 / RecruitingNot ApplicableIIT

The Effects Of Heart Coherence Training On Patients With Vascular Ehlers-Danlos Syndrome (HEARTMATH)

Vascular Ehlers-Danlos Syndrome (VEDS) is caused by pathogenic variants of the COL3A1 gene, resulting abnormal Type III collagen protein. This impacts the body's connective tissue and makes people with VEDS at high risk of spontaneous aortic and arterial rupture, pneumothorax, and hollow organ perforation across the age spectrum. Given this risk and high potential for lethality, VEDS is considered the most severe type of Ehlers-Danlos Syndrome. In addition, many patients experience chronic pain and fatigue, sleep disturbances, and mental health challenges. As is the case for many patients with chronic illness, stress, anxiety, and depression are often present over the course of the disease. Despite the antecedent, stress and anxiety trigger a sympathetic nervous system (SNS) response in the body, which, over a period of time, can have detrimental effects both physiologically and psychologically for patients. Recent studies have begun to use biofeedback techniques to teach patients non-pharmacological strategies for managing their autonomic nervous system. One such program, Heartmath®, has been successful in helping patients lower stress, anxiety, and systolic blood pressure. This pilot trial was established to assess the effectiveness of a virtually based heart coherence program in a population with a chronic aortopathy in an effort to establish a larger, multi-provider program that also encompasses other cardiovascular populations.

Start Date01 Apr 2024

Sponsor / Collaborator

Baylor College of Medicine

[+1]

NCT05809323 / RecruitingNot ApplicableIIT

Clinical Trial On The Effects Of Moderate Physical Activity On Health And Well-Being In Adolescents And Young Adults With Marfan Syndrome

Marfan syndrome (MFS) is a distinctive connective tissue disorder that affects multiple organ systems including the heart, bones, ligaments, and eyes, and is associated with significant risk of aortic dissection. Given limited evidence from in-vitro studies, and theoretical concerns, the majority of patients with MFS are restricted from certain physical activities. The lack of exercise and deconditioning have detrimental effects including increasing weakness, joint pain, decreased endurance, and depressive symptoms. Given the significant paucity of data currently existing on the effects of exercise in humans with MFS, and the recent, optimistic findings in rodent models, this pilot trial was established to assess the effects of moderated dynamic exercise in adolescents and young adults with MFS.

Start Date01 Sep 2023

Sponsor / Collaborator

Baylor College of Medicine

[+1]

100 Clinical Results associated with Southern Star Research Pty Ltd.

0 Patents (Medical) associated with Southern Star Research Pty Ltd.

Literatures (Medical) associated with Southern Star Research Pty Ltd.

01 Feb 2022·ESMO OpenQ3 · MEDICINE

Results of a single-arm pilot study of 32P microparticles in unresectable locally advanced pancreatic adenocarcinoma with gemcitabine/nab-paclitaxel or FOLFIRINOX chemotherapy

Q3 · MEDICINE

ArticleOA

Author: Bartholomeusz, D ; James, D C ; Nagrial, A M ; Harris, M T ; Ross, P J ; Nguyen, N ; Wilson, N E ; Iwuji, C ; Wasan, H S ; Turner, D M ; Nikfarjam, M ; Ajithkumar, T ; Aghmesheh, M ; Young, E ; Croagh, D ; Hendlisz, A

BACKGROUNDUnresectable locally advanced pancreatic cancer (LAPC) is generally managed with chemotherapy or chemoradiotherapy, but prognosis is poor with a median survival of ∼13 months (or up to 19 months in some studies). We assessed a novel brachytherapy device, using phosphorous-32 (³²P) microparticles, combined with standard-of-care chemotherapy.PATIENTS AND METHODSIn this international, multicentre, single-arm, open-label pilot study, adult patients with histologically or cytologically proven unresectable LAPC received ³²P microparticles, via endoscopic ultrasound-guided fine-needle implantation, planned for week 4 of 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (FOLFIRINOX) or gemcitabine/nab-paclitaxel chemotherapy, per investigator's choice. The primary endpoint was safety and tolerability measured using Common Terminology Criteria for Adverse Events version 4.0. The lead efficacy endpoint was local disease control rate at 16 weeks.RESULTSFifty patients were enrolled and received chemotherapy [intention-to-treat (ITT) population]. Forty-two patients received ³²P microparticle implantation [per protocol (PP) population]. A total of 1102 treatment-emergent adverse events (TEAEs) were reported in the ITT/safety population (956 PP), of which 167 (139 PP) were grade ≥3. In the PP population, 41 TEAEs in 16 (38.1%) patients were possibly or probably related to ³²P microparticles or implantation procedure, including 8 grade ≥3 in 3 (7.1%) patients, compared with 609 TEAEs in 42 (100%) patients attributed to chemotherapy, including 67 grade ≥3 in 28 patients (66.7%). The local disease control rate at 16 weeks was 82.0% (95% confidence interval: 68.6% to 90.9%) (ITT) and 90.5% (95% confidence interval: 77.4% to 97.3%) (PP). Tumour volume, carbohydrate antigen 19-9 levels, and metabolic tumour response at week 12 improved significantly. Ten patients (20.0% ITT; 23.8% PP) had surgical resection and median overall survival was 15.2 and 15.5 months for ITT and PP populations, respectively.CONCLUSIONSEndoscopic ultrasound-guided ³²P microparticle implantation has an acceptable safety profile. This study also suggests clinically relevant benefits of combining ³²P microparticles with standard-of-care systemic chemotherapy for patients with unresectable LAPC.

01 Sep 2019·Clinical TherapeuticsQ4 · MEDICINE

A High-dose Pharmacokinetic Study of a New IgG4 Monoclonal Antibody Temelimab/GNbAC1 Antagonist of an Endogenous Retroviral Protein pHERV-W Env

Q4 · MEDICINE

Article

Author: Kornmann, Gabrielle ; Porchet, Hervé ; Curtin, François ; Malpass, Sam ; Vidal, Virginie

PURPOSETemelimab/GNbAC1 is a humanized immunoglobulin G4 monoclonal antibody antagonist of the human endogenous retrovirus W envelope protein, which is associated with multiple sclerosis (MS) pathophysiology and possibly with other autoimmune disorders. Human endogenous retrovirus W envelope protein is expressed in the central nervous system of patients with MS, and sufficient amount of temelimab must reach the target. The safety of very high dosages of temelimab should be tested to support further clinical trials in MS.METHODSThis randomized, placebo-controlled, dose-escalation study evaluated the safety and pharmacokinetic profile of temelimab in 24 healthy volunteers after a single intravenous infusion at doses of 36, 60, 85, and 110 mg/kg administered sequentially.FINDINGSTemelimab was well tolerated, with no particular adverse drug reactions at any dose. The maximal dose of 110 mg/kg could be administered, and no antidrug antibodies were induced. After administration of 36-110 mg/kg, mean temelimab C_max increased from 859 to 2450 μg/mL, and AUC values increased from 319,900 to 1,030,000 μg·h/mL. There was an approximate dose-proportional increase in exposure, similar to observations at lower doses.IMPLICATIONSThe favorable data in terms of safety and pharmacokinetic variables support temelimab use at high doses in future MS trials to optimally neutralize the temelimab target in the central nervous system. ClinicalTrials.gov identifier: NCT03574428.

PLOS ONE

Impact of a Patient Support Program on time to discontinuation of adalimumab in Australian adult patients with immune-mediated inflammatory diseases–an observational study

Article

Author: Calao, Miriam ; Begun, Jakob ; Fernández-Peñas, Pablo ; Watts, Alan ; Kouhkamari, Mahsa H ; Östör, Andrew J ; Sin, Shirley ; Jones, Graeme ; Young, Elisa

This observational study evaluated the impact of a sponsor company-provided Patient Support Program (PSP) on discontinuation of adalimumab in adult Australian patients eligible for Pharmaceutical Benefit Scheme (PBS)-reimbursed adalimumab for Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn’s Disease (CD), Ulcerative Colitis (UC), or Hidradenitis Suppurativa (HS). Patients initiating adalimumab between May 2018 and September 2019 were enrolled into two prospective cohorts based on their decision to opt for or decline the PSP (PSP or non-PSP cohorts). In addition, a historical, retrospective Non-PSP cohort was established from the Services Australia 10% PBS dataset by extracting data of patients initiating adalimumab prior to the introduction of adalimumab PSPs and based on adalimumab PBS listing dates (AS: April 2007 to March 2009; PsA/RA: January 2007 to December 2008; CD: January 2009 to December 2010; HS and UC indications not included). Follow-up for all cohorts was 12 months. The primary endpoint was the time to discontinuation, compared between the prospective PSP cohort and the prospective or retrospective Non-PSP cohort. Inverse probability of treatment weighting was used to balance the cohorts. A Cox proportional hazards model indicated no difference in time to discontinuation between the prospective PSP (n = 162) and non-PSP (n = 65) cohorts (HR [95% CI] = 1.256 [0.616–2.563], p = 0.5304). The 12-month adalimumab persistence rates (95% CI) were 78% (69%, 84%) and 82% (67%, 90%), respectively. In contrast, discontinuation was less likely in the prospective PSP (n = 151) compared with the retrospective non-PSP (n = 297) cohort (HR [95% CI] = 0.44 [0.28–0.68], p<0.001). The 12-month persistence rates (95% CI) were 81% (76%, 90%) and 61% (56%, 67%), respectively. Overall, this study suggests that optimal adalimumab persistence can be achieved with either a structured PSP or healthcare support from other sources, but this was not the case more than a decade ago.

News (Medical) associated with Southern Star Research Pty Ltd.

03 Sep 2024

·www.prnewswire.com

Halia Therapeutics Joins Forces with Southern Star Research Pty Ltd to Advance Clinical Development of Novel LRRK2 Inhibitor, HT-4253 for Neurodegenerative Diseases

LEHI, Utah , Sept. 3, 2024 /PRNewswire/ -- Halia Therapeutics, Inc. (Halia), a clinical-stage biopharmaceutical company at the forefront of developing innovative treatments for inflammatory and neurodegenerative diseases, today announced a pivotal strategic collaboration with Southern Star Research Pty Ltd, a leading Australian contract research organization (CRO). This partnership marks the initiation of a Phase 1 clinical trial for Halia's pioneering LRRK2 inhibitor, HT-4253, signaling a significant leap in the fight against debilitating neurodegenerative conditions such as Alzheimer's Disease. "Partnering with Southern Star Research is a strategic milestone for Halia as we advance HT-4253 into clinical development. Their expertise and unwavering dedication to clinical excellence make them the perfect ally in our mission to develop innovative therapies that target the root causes of neurodegeneration," said Dr. David J Bearss, CEO at Halia Therapeutics. "The initiation of this Phase 1 trial is not just a step forward for Halia but a hopeful stride towards potentially life-changing treatments for patients worldwide." David Lloyd, Managing Director of Southern Star Research, expressed enthusiasm for the collaboration, stating: "We are excited to collaborate with Halia Therapeutics on the Phase I SAD/MAD study of HT-4253 in healthy volunteers. This partnership represents a significant step in our long-term commitment to advancing novel therapeutics for the treatment of neurodegenerative diseases such as Alzheimer's Disease, an area with an enormous unmet need. Our team is dedicated to supporting the development of pioneering treatments such as HT-4253, and we look forward to contributing to the success of this important clinical trial and many more in the future." The trial is set to commence in Q4 2024, with preliminary results expected in 2025. Halia and Southern Star Research are committed to upholding the highest standards of safety, compliance, and scientific integrity throughout the study, with the combined mission to bring hope to the millions affected by neurodegenerative diseases. About HT-4253 Clinical Trial The Phase 1 clinical trial (NCT06537817) will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HT-4253 in healthy volunteers. This study will employ a single ascending dose (SAD) and multiple ascending dose (MAD) format, designed to explore the potential of HT-4253 to inhibit LRRK2—a critical enzyme implicated in the pathogenesis of neuroinflammatory and neurodegenerative diseases, including Alzheimer's Disease and Parkinson's Disease. About HT-4253 HT-4253 is an orally administered small molecule with excellent brain penetration that targets a mediator of neuroinflammation called LRRK2. Chronic inflammation in the brain is a driver of several neurodegenerative diseases, such as Parkinson's disease and Alzheimer's disease. Halia scientists have shown that LRRK2 is an essential regulator of neuroinflammation. LRRK2 inhibition by HT-4253 could represent a new way to treat neurodegenerative diseases with an inflammation component by changing how the disease progresses. About Halia Therapeutics, Inc. Halia Therapeutics is discovering and developing a pipeline of novel therapeutics to improve patients' lives with chronic inflammatory disorders and neurodegenerative diseases, with its initial programs targeting NEK7 and LRRK2. Halia's lead candidate, HT-6184, a novel NEK7/NLRP3 inhibitor, has completed a Phase I study (NCT05447546) evaluating the safety and tolerability of HT-6184 when administered as single or multiple oral doses at escalating dose levels in healthy volunteer subjects. Halia has also initiated 2 Phase II trials to evaluate the efficacy of HT-6184 for the treatment of lower-risk myelodysplastic syndromes (LR-MDS) and on post-procedure diagnostic biomarkers of inflammation and pain (NCT06241742). The company's headquarters are in Lehi, Utah. For more information, visit or follow us on LinkedIn and Twitter (X). About Southern Star Research Pty Ltd Southern Star Research Pty Ltd is an Australian full-service CRO specializing in providing clinical trial services for biotechnology and pharmaceutical companies. With a strong focus on quality and partnership, Southern Star is dedicated to advancing clinical research and helping bring innovative therapies to patients. Company Contact Halia Therapeutics [email protected] +1.385.355.4315 Media Contact: Ignacio Guerrero-Ros, Ph.D. Russo Partners, LLC +1 (646) 942-5604 [email protected] SOURCE Halia Therapeutics

Phase 1Phase 2

100 Deals associated with Southern Star Research Pty Ltd.

100 Translational Medicine associated with Southern Star Research Pty Ltd.

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Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

MMV367	Malaria, Falciparum More	Phase 1

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