Phase Ib Dose Escalating Study to Evaluate the Safety, Tolerability and Pharmacodynamic Response of Foxy-5 in Patients With Metastatic Breast-, Colon- or Prostate Cancer

The Wnt proteins belong to a family of proteins that have been demonstrated to play a role in the formation and dissemination of tumours. The present project focuses on the critical role of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer disease.
WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby acting anti-metastatic.
The aim of the first clinical phase I study was to establish the recommended dose for a clinical phase II study and enable further development of Foxy-5 as a first in class anti-metastatic cancer drug. The study did not see any DLTs and therefore failed to reach maximum tolerated dose (MTD); no recommended phase II dose (RP2D) could therefore be established based on toxicity. The aim of this study is to continue to establish the safety profile of Foxy-5 in higher doses, and determine the RP2D for later stage development based on any observed DLT's/MTD and further analysis of the pharmacodynamic profile of Foxy-5 to determine the biological response dose (BRD).

Start Date01 Apr 2016

Sponsor / Collaborator

Wntresearch AB

100 Clinical Results associated with Foxy-5

100 Translational Medicine associated with Foxy-5

100 Patents (Medical) associated with Foxy-5

Literatures (Medical) associated with Foxy-5

14 Aug 2024·Journal of the American Chemical Society

A Cyanine Dye for Highly Specific Recognition of Parallel G-Quadruplex Topology and Its Application in Clinical RNA Detection for Cancer Diagnosis

Article

Author: Liu, Jing ; Li, Qian ; Sun, Ranran ; Yang, Dawei ; Yao, Li ; Zhou, Tianxing ; Bai, Ruiyang ; Xiang, Junfeng ; Sun, Hongxia ; Jiang, Wenna ; Zhang, Boyang ; Zhong, Fanru ; Tang, Yalin

G-quadruplex (G4), an unconventional nucleic acid structure, shows polymorphism in its topological morphology. The parallel G4 topology is the most prevalent form in organisms and plays a regulatory role in many biological processes. Designing fluorescent probes with high specificity for parallel G4s is important but challenging. Herein, a supramolecular assembly of the anionic cyanine dye SCY-5 is reported, which selectively identifies parallel G4 topology. SCY-5 can clearly distinguish parallel G4s from other G4s and non-G4s, even including hybrid-type G4s with parallel characteristics. The high specificity mechanism of SCY-5 involves a delicate balance between electrostatic repulsion and π-π interaction between SCY-5 and G4s. Using SCY-5, cellular RNA extracted from peripheral venous blood was quantitatively detected, and a remarkable increase in RNA G4 content in cancer patients compared to healthy volunteers was confirmed for the first time. This study provides new insights for designing specific probes for parallel G4 topology and opens a new path for clinical cancer diagnosis using RNA G4 as a biomarker.

01 Jul 2024·Ophthalmic and Physiological Optics

Assessing neophyte response to daily disposable silicone hydrogel contact lenses: A randomised clinical trial investigation over one month

Article

Author: Garcia-Queiruga, Jacobo ; Giraldez, Maria J ; Noya-Padin, Veronica ; Pena-Verdeal, Hugo ; Yebra-Pimentel, Eva ; Ferreiro-Figueiras, Dolores

AbstractObjectiveThis randomised clinical trial assessed the impact on symptoms, tear film dynamics and ocular surface integrity of daily disposable silicone‐hydrogel contact lenses (CLs) over a month, paying special attention to lid wiper epitheliopathy (LWE) and its implications for CL discomfort.MethodsNeophyte CL wearers (n = 44, 21.09 ± 5.00 years old) were randomly assigned to either the experimental (n = 24) or control group (n = 20). Participants assigned to the experimental group were required to wear daily disposable CLs for 1 month for at least 8 h/day and 6 days/week. All participants were healthy subjects (no history of ocular surgery or active ocular disease) with spherical refractive errors between −8.00 and +5.00 D and cylindrical power <0.75 D. At the baseline and 1‐month sessions, the Dry Eye Questionnaire 5 (DEQ‐5) was completed, together with the measurement of tear film osmolarity with the TearLab osmometer, tear meniscus height (TMH) and lipid layer pattern (LLP) using a slit‐lamp with Tearscope Plus attached, fluorescein break‐up time (FBUT), maximum blink interval (MBI), corneal staining with fluorescein under cobalt blue light and LWE with lissamine green under slit lamp and halogen white light.ResultsAt the baseline session, LWE showed a negative correlation with DEQ‐5 (r = −0.37, p = 0.02). Significant differences in FBUT and LWE (p = 0.04) and a positive correlation between LWE and DEQ‐5 (r = 0.49, p = 0.007) were observed at 1 month. Intrasession analysis at 1 month showed significant differences between the experimental and control groups in DEQ‐5, FBUT and LWE (all p ≤ 0.02). Intersession analysis in the experimental group showed variations in DEQ‐5, FBUT and LWE (all p ≤ 0.02) but no significant variation in the control group (all p ≥ 0.11).ConclusionThe presence of LWE was significantly correlated with higher symptom values in the DEQ‐5. Also, participants in the experimental group presented higher values of LWE after 1 month of CL wear, in comparison with the control group.

01 Feb 2024·Ophthalmology and Therapy

Multi-symptom Relief with Propylene Glycol-Hydroxypropyl-Guar Nanoemulsion Lubricant Eye Drops in Subjects with Dry Eye Disease: A Post-Marketing Prospective Study

Article

Author: Tauber, Joseph ; Awisi-Gyau, Deborah ; Miller, Jason R ; Bickle, Katherine

INTRODUCTIONThe study aimed to evaluate multi-symptom relief of dry eye manifestations with the use of propylene glycol-hydroxypropyl-guar (PG-HPG) nanoemulsion lubricant eye drops, among subjects with dry eye disease (DED).METHODSThis was a post-marketing, prospective, single-arm study conducted in the USA. Subjects aged ≥ 18 years, with tear breakup time (TBUT) ≤ 10 s for both eyes, dry eye questionnaire-5 (DEQ-5) "watery eyes" symptom score 1-4, symptoms of burning/stinging, sore and tired eyes as determined by impact of dry eye on everyday living-symptom bother (IDEEL-SB) questionnaire, and IDEEL-SB score 16-65 were included. Subjects were required to complete IDEEL-SB and DEQ-5 at days 0, 14 ± 2, and 28 ± 2, and self-administer one drop of PG-HPG four times daily for 28 ± 2 days. Primary endpoints were change from baseline at day 28 in symptoms of sore, stinging/burning, and tired eyes on IDEEL-SB; and symptom of watery eyes on DEQ-5. Other endpoints evaluated were corneal staining and TBUT at baseline and day 28 ± 2; symptom relief (5-point Likert scale) at day 28 ± 2, and safety.RESULTSOf 119 subjects enrolled, 95 completed the study (mean ± SD age 61.2 ± 13.0 years; female 69.5%). Mean IDEEL-SB scores reduced significantly from baseline at day 28 for symptoms of aching/sore eyes (change from baseline - 1.0 ± 1.1), burning/stinging eyes (change from baseline - 1.1 ± 0.9), and tired eyes (change from baseline - 1.1 ± 1.0) (all p < 0.0001). Mean DEQ-5 score for watery eye symptoms significantly reduced from baseline at day 28 (change from baseline - 0.9 ± 1.0, p < 0.0001). Corneal staining at day 28 was comparable to baseline. TBUT improved from baseline to day 28. On a Likert scale, more than 50% of subjects reported relief from symptoms of sore, stinging, and burning eyes. Three (3.1%) subjects reported treatment-emergent adverse events (non-ocular).CONCLUSIONSPG-HPG nanoemulsion lubricant eye drops significantly improved multiple dry eye symptoms in subjects with DED over 28 days, with no new safety concerns.TRIAL REGISTRATIONClinicalTrials.gov Identifier, NCT05056155.

100 Deals associated with Foxy-5

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colonic Cancer	Phase 2	ES	Wntresearch AB	12 Apr 2019
Metastatic colon cancer	Phase 1	GB	Wntresearch AB	01 Apr 2016
Metastatic Prostate Carcinoma	Phase 1	DK	Wntresearch AB	01 Apr 2016
Metastatic Prostate Carcinoma	Phase 1	GB	Wntresearch AB	01 Apr 2016
Metastatic breast cancer	Phase 1	DK	Wntresearch AB	01 Jun 2013
Metastatic colon cancer	Discovery	DK	Wntresearch AB	01 Apr 2016
Neoplasm Metastasis	Discovery	GB	Wntresearch AB	01 Apr 2016
Neoplasm Metastasis	Discovery	DK	Wntresearch AB	01 Apr 2016

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