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  • ||||||||||  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
  • ||||||||||  vosilasarm (EP0062) / Ellipses Pharma
    Harm From SARMs: RAD-140, A Selective Androgen Receptor Modulator Leading to Acute Liver Injury (Exhibit Hall) -  Jul 29, 2023 - Abstract #ACG2023ACG_1597;    
    Despite the FDA warning against SARM use in body-building products, SARM abuse is a rising problem among athletes. Clinicians should strongly recommend against recreational SARM use and educate patients about the negative effects of these unregulated substances.
  • ||||||||||  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
    Enrollment open, Metastases:  A Study of EP0031-101 in Patients With Advanced RET-altered Malignancies (clinicaltrials.gov) -  Oct 27, 2022   
    P1/2,  N=265, Recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Mar 2023 Not yet recruiting --> Recruiting
  • ||||||||||  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. .
  • ||||||||||  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.
  • ||||||||||  vosilasarm (RAD140) / Radius, Ostarine (enobosarm) / Veru Inc, ligandrol (VK5211) / Viking Therap
    Journal:  The forensic response after an adverse analytical finding (doping) involving a selective androgen receptor modulator (SARM) in human athlete. (Pubmed Central) -  Nov 17, 2021   
    To date, all methods for SARMs identification in various matrices involve liquid chromatography coupled to tandem mass spectrometry or high-resolution mass spectrometry. The aim of this paper is to review the scientific literature on the analytical possibilities of testing SARMs in dietary supplements, urine and hair or nail clippings after an AAF to document the claims of an athlete or his/her legal team.