- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma, docetaxel-loaded nanopharmaceutical (CRLX301) / Ellipses Pharma
Review, Journal, Combination therapy: Multifunctionality of cyclodextrin-based polymeric nanoparticulate delivery systems for chemotherapeutics, combination therapy, and theranostics. (Pubmed Central) - Apr 9, 2024 Further, in light of recent studies, the article majorly focuses on conveying how promoting CD to a polymeric and nanoscale elevates the multifunctional advantages against cancer that can be successfully applied in combination therapy and theranostics. Moreover, CD-based delivery systems including CALAA-01, CRLX101, and CRLX301, have demonstrated improved tumor targeting, reduced side effects, and prolonged drug release in preclinical studies and clinical trials.
- |||||||||| vosilasarm (EP0062) / Ellipses Pharma
Journal: Social Interest Data as a Proxy for Off-Label Performance-Enhancing Drug Use: Implications and Clinical Considerations. (Pubmed Central) - Feb 12, 2024 A significant increase in interest regarding selective androgen receptor modulators, mirrored by anecdotal reports in clinical settings and online forums, is coupled with stagnant or decreasing interest in both post-cycle therapies and anabolic steroids. Ultimately, we propose a call to action for utilizing social data and/or prescription data as a proxy for clinicians to better understand trends in these compounds and thus refine their treatment protocols in a concordant manner.
- |||||||||| EP0042 / Ellipses Pharma
Trial completion date, Trial primary completion date, Combination therapy, Metastases: EP0042-101: Study to Evaluate the Safety and Tolerability of EP0042 (clinicaltrials.gov) - Jan 3, 2024 P1/2, N=50, Recruiting, Ultimately, we propose a call to action for utilizing social data and/or prescription data as a proxy for clinicians to better understand trends in these compounds and thus refine their treatment protocols in a concordant manner. Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Sep 2023 --> Oct 2025
- |||||||||| vosilasarm (EP0062) / Ellipses Pharma
Journal: A rapid synthesis of molecularly imprinted polymer nanoparticles for the extraction of performance enhancing drugs (PIEDs). (Pubmed Central) - Sep 28, 2023 Further cohorts are planned for evaluation of EP0042 in combination with standard of care therapies. With the SARMs-based nanoMIPs being able to rebind 94.08 and 94.46% of their target molecules (andarine, and RAD-140, respectively), while the steroidal-based nanoMIPs were able to rebind 96.62 and 96.80% of their target molecules (estradiol and testosterone, respectively)...While the non-imprinted control polymer (NIP) shows a decrease in affinity with K values of 3.40
- |||||||||| vosilasarm (EP0062) / Ellipses Pharma
Preclinical, Journal: Comparison of in vitro approaches for predicting the metabolism of the selective androgen receptor modulator RAD140. (Pubmed Central) - Sep 7, 2023 With the SARMs-based nanoMIPs being able to rebind 94.08 and 94.46% of their target molecules (andarine, and RAD-140, respectively), while the steroidal-based nanoMIPs were able to rebind 96.62 and 96.80% of their target molecules (estradiol and testosterone, respectively)...While the non-imprinted control polymer (NIP) shows a decrease in affinity with K values of 3.40 In the organ
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial completion, Enrollment change, Combination therapy, Metastases: EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov) - Aug 2, 2023 P2, N=34, Completed, In the organ Active, not recruiting --> Completed | N=60 --> 34
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Enrollment change, Trial withdrawal, Combination therapy, Metastases: EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer (clinicaltrials.gov) - Jun 12, 2023 P2, N=0, Withdrawn, Toxicity was generally manageable, with common adverse events including fatigue, nausea, and anemia. N=115 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| EP0031 / Sichuan Kelun Pharma, Ellipses Pharma
A modular, open-label, phase I/II study to evaluate the safety, tolerability, pharmacokinetics and efficacy of EP0031, a next generation selective RET inhibitor, in patients with advanced RET-altered malignancies (Section 46; Poster Board #15) - Mar 14, 2023 - Abstract #AACR2023AACR_7141; P1/2 For expansion cohorts patients must have a solid tumor measurable by RECIST v1.1, with/without asymptomatic, stable brain metastasesRecruitment was initiated in the US in November 2022 and is expanding to centers across Europe and rest of world. A parallel Phase I/II trial is ongoing in China (A400, NCT05265091, Kelun Biotech).1Annals of Oncology 32(2) S66 (2021)2Journal Thoracic Oncol 15(4) 542 (2020)
- |||||||||| vosilasarm (EP0062) / Ellipses Pharma
Journal: Pharmacological targeting of androgen receptor elicits context-specific effects in estrogen receptor-positive breast cancer. (Pubmed Central) - Dec 6, 2022 In contrast, RAD140 activated AR signaling and suppressed AR-high tumor growth by deregulating ERα expression and blocking ERα function. Overall, analysis of the dynamic efficacies and outcomes of AR agonist and antagonist in the presence of different AR and ERα levels reveals regulators of response and supports the clinical investigation of ENZ in selected ER+ tumors with a low AR/ER ratio and AR agonists in tumors with a high AR/ER ratio.
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial initiation date, Combination therapy, Metastases: EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer (clinicaltrials.gov) - Nov 2, 2022 P2, N=115, Not yet recruiting, Once a RP2D is confirmed, a single arm dose expansion is planned in FLT3 mutated and wild type R/R AML, and the combination of EP0042 with other agents will be explored. Initiation date: Jul 2022 --> Apr 2023
- |||||||||| davamotecan pegadexamer (EP0057) / Ellipses Pharma
Enrollment closed, Trial completion date, Combination therapy, Metastases: EP0057 in Combination With Olaparib in Advanced Ovarian Cancer (clinicaltrials.gov) - Nov 2, 2022 P2, N=60, Active, not recruiting, Initiation date: Jul 2022 --> Apr 2023 Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Mar 2023
- |||||||||| EP0031 / Sichuan Kelun Pharma, Ellipses Pharma
New P1/2 trial, Metastases: A Study of KL590586 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Mar 2, 2022 P1/2, N=414, Enrolling by invitation, RAD140 is a novel oral AR-targeted agent for the treatment of AR+/ER+/HER2- mBC with an acceptable safety profile and preliminary evidence of target engagement and antitumor activity. .
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial completion date, Trial primary completion date, Metastases: Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment (clinicaltrials.gov) - Feb 8, 2022 P2, N=3, Completed, . Trial completion date: Feb 2022 --> Jun 2021 | Trial primary completion date: Feb 2022 --> May 2021
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, davamotecan pegadexamer (EP0057) / Ellipses Pharma
Trial completion, Trial completion date, Trial primary completion date, Metastases: Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment (clinicaltrials.gov) - Feb 4, 2022 P2, N=3, Completed, Trial completion date: Feb 2022 --> Jun 2021 | Trial primary completion date: Feb 2022 --> May 2021 Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Feb 2022 | Trial primary completion date: Dec 2022 --> Feb 2022
- |||||||||| docetaxel-loaded nanopharmaceutical (CRLX301) / Ellipses Pharma
Clinical, P1/2 data, Journal: First-in-human, phase I/IIa study of CRLX301, a nanoparticle drug conjugate containing docetaxel, in patients with advanced or metastatic solid malignancies. (Pubmed Central) - Feb 3, 2022 P1/2 CRLX301 exhibited some PK advantages over docetaxel including higher retention of drug in plasma, slower clearance and controlled slow release of docetaxel from the carrier. Conclusions In this heavily pretreated patient population, the safety profile was acceptable for CRLX301 therapy. There was some evidence of preliminary tumor efficacy, but further work is necessary to find the optimal dose and schedule of this formulation.Clinicaltrials.gov trial registration number: NCT02380677 (Date of registration: March 2, 2015).
- |||||||||| vosilasarm (RAD140) / Radius
Biomarker, Journal: Label-free proteomics for discovering biomarker candidates of RAD140 administration to castrated horses. (Pubmed Central) - Dec 16, 2021 This is the first reported study that describes the use of a proteomic biomarker approach to detect horses that have been administered with RAD140 by applying label-free proteomic profiling of plasma samples. These results support the concept of a biomarker driven approach to enhance the doping control of RAD140 and potentially other SARMs in the future.
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