A Phase 2 Study of Relacorilant in Combination With Nab-paclitaxel and Bevacizumab in Advanced, Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (BELLA)

This is a Phase 2, single-arm, open-label study to evaluate efficacy and safety of intermittent dosing of relacorilant in combination with nab-paclitaxel and bevacizumab in patients with ovarian cancer.

Start Date11 Apr 2025

Sponsor / Collaborator

Corcept Therapeutics, Inc.

NCT05726292

/ RecruitingPhase 2IIT

A Randomized Phase II Trial of Neoadjuvant Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer

Researchers conducting this study hope to learn about the safety and effectiveness of combining two study drugs, relacorilant and enzalutamide, plus androgen deprivation therapy (ADT), also known as hormone therapy. This study is for individuals who have been diagnosed with advanced, high-risk prostate cancer and standard therapies available to treat your disease have not been effective. Participation in this research will last about 3 years and 9 months.

Start Date06 Jan 2025

Sponsor / Collaborator

The University of Chicago

NCT05257408

/ Active, not recruitingPhase 3

A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)

The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of Relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.

Start Date29 Jun 2022

Sponsor / Collaborator

Corcept Therapeutics, Inc.

[+1]

100 Clinical Results associated with Relacorilant

100 Translational Medicine associated with Relacorilant

100 Patents (Medical) associated with Relacorilant

Literatures (Medical) associated with Relacorilant

04 Nov 2024·The Oncologist

Relacorilant plus nab-paclitaxel for the treatment of metastatic pancreatic ductal adenocarcinoma: results from the open-label RELIANT study

Article

Author: Borazanci, Erkut H ; Leal, Alexis D ; Oberstein, Paul E ; Huyck, Timothy K ; Mann, Grace ; Bahary, Nathan ; Chiorean, Elena Gabriela ; Fountzilas, Christos ; Hanna, Wahid T ; Cardin, Dana B ; Chung, Vincent ; Kio, Ebenezer A ; Pashova, Hristina ; Lee, Valerie ; Alese, Olatunji B ; Skeel, Roland T ; Noonan, Anne M ; Wainberg, Zev A ; Philip, Philip A

AbstractBackgroundModulation of glucocorticoid receptor (GR) activity in tumor cells enhances chemotherapy efficacy. We evaluated the selective GR modulator relacorilant plus nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who had received at least 2 prior therapy lines.Patients and MethodsIn this open-label, single-arm, phase III study, patients received once-daily oral relacorilant (100 mg, titrated to 150 mg in 25 mg increments/cycle) and nab-paclitaxel (80 mg/m2) on days 1, 8, and 15 of 28-day cycles. The primary efficacy endpoint was objective response rate (ORR) by blinded independent central review. Progression-free survival (PFS), overall survival (OS), target gene modulation, and safety were also assessed.ResultsOf 43 patients enrolled, 31 were evaluable for ORR (12 did not reach first postbaseline radiographic assessment). An interim analysis to assess whether ORR was ≥10% showed no confirmed responses and the study was discontinued. Two (6.5%) patients attained unconfirmed partial responses and 15 (48.4%) had stable disease. Fourteen of 31 (45.2%) patients had reductions in target lesion size, despite prior nab-paclitaxel exposure in 12 of the 14. Median PFS and OS were 2.4 months (95% CI, 1.4-4.2) and 3.9 months (95% CI, 2.8-4.9), respectively. The most common adverse events were fatigue and nausea. RNA analysis confirmed that relacorilant plus nab-paclitaxel suppressed 8 cortisol target genes of interest.ConclusionRelacorilant plus nab-paclitaxel showed modest antitumor activity in heavily pretreated patients with mPDAC, with no new safety signals. Studies of this combination in other indications with a high unmet medical need are ongoing.

02 Aug 2024·Expert Review of Anticancer Therapy

Relacorilant in recurrent ovarian cancer: clinical evidence and future perspectives

Review

Author: Sassu, Carolina Maria ; Ghizzoni, Viola ; Fagotti, Anna ; Marchetti, Claudia ; Giudice, Elena ; Salutari, Vanda ; Vertechy, Laura ; Carbone, Maria Vittoria ; Scambia, Giovanni

INTRODUCTIONRelacorilant (CORT125134, Corcept Therapeutics) is a selective glucocorticoid receptor modulator, which reverses the glucocorticoid-mediated anti-apoptotic effects and restores the taxane chemosensitivity in epithelial ovarian cancer cells. Given those preclinical findings, relacorilant is currently under investigation in clinical trials in combination with nab-paclitaxel for the platinum-resistant ovarian cancer setting.AREAS COVEREDAlready published preclinical and clinical evidence of relacorilant antitumor activity was analyzed and discussed. Ongoing clinical trials registered on clincaltrials.gov were also reported. The review aimed to summarize the status of relacorilant, the mechanism of action, the published and ongoing trials, and its safety and efficacy.EXPERT OPINIONRelacorilant combined with nab-paclitaxel, may represent a promising strategy for the treatment of platinum-resistant ovarian cancer patients. After preliminary positive results in terms of clinical efficacy, a randomized phase III trial is ongoing to confirm the findings from the published phase II study.

03 Jun 2024·Clinical Cancer Research

A Phase I Trial of Enzalutamide Plus Selective Glucocorticoid Receptor Modulator Relacorilant in Patients with Metastatic Castration-Resistant Prostate Cancer

Article

Author: Sweis, Randy F. ; Stadler, Walter M. ; O'Donnell, Peter H. ; Szmulewitz, Russell Z. ; Desai, Kunal B. ; Serritella, Anthony V.

AbstractPurpose:The majority of patients with metastatic prostate cancer who receive androgen-deprivation therapy and androgen receptor (AR) signaling inhibitors (ARSI) progress. Activation of the glucocorticoid receptor (GR) is associated with ARSI resistance. This single-arm phase I trial assessed safety and pharmacokinetic (PK) feasibility of a combined AR antagonist (enzalutamide) and selective GR modulator (relacorilant) in patients with metastatic castration-resistant prostate cancer (mCRPC).Patients and Methods:This was a phase I trial (NCT03674814) of relacorilant and enzalutamide in patients with refractory mCRPC enrolled using a 6+3 design. The enzalutamide dose was kept constant at 120 mg/d with escalating doses of relacorilant based on safety and PK measures in cohorts of ≥6 patients. The primary objective was safety and establishment of pharmacologically active doses. Secondary objectives were related to antitumor activity.Results:Thirty-five patients with mCRPC were enrolled. Twenty-three were accrued across three dose cohorts in the dose-escalation phase, and 12 enrolled at the recommended phase II dose. The combination was generally well tolerated, safe, and achieved desirable enzalutamide PK. RP2D of 120 + 150 mg/d, respectively, was established. Median time on study was 2.2 months with four patients remaining on study for longer than 11 months. Four of 12 evaluable patients had a prostate-specific antigen (PSA) partial response.Conclusions:This is the first prospective trial combining an AR antagonist and a nonsteroidal selective GR modulator. The combination was safe and well tolerated with PSA response and prolonged disease control observed in a limited subset of patients. Further prospective trials are justified to evaluate efficacy and identify predictive biomarkers of response.

News (Medical) associated with Relacorilant

31 Mar 2025

·pipelinereview.com

Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer

REDWOOD CITY, CA, USA I March 31, 2025 I Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that ROSELLA, the company’s pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR). In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). Their median PFS-BICR was 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. At an interim evaluation of overall survival (OS), patients treated with relacorilant plus nab-paclitaxel had a significant improvement in OS, with a median OS of 16.0 months, compared to 11.5 months for patients receiving nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.012). Relacorilant was well-tolerated and no new safety signals were observed. As was the case in the company’s Phase 2 trial, safety and tolerability were comparable in the two groups. Complete results from ROSELLA will be presented at a medical conference this year. Results from Corcept’s Phase 2 trial of relacorilant in patients with platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology in June 2023. The ROSELLA trial enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia; biomarker selection was not required. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. ROSELLA has dual primary endpoints — PFS-BICR and OS. A positive outcome is achieved if either endpoint is met. “Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies. The ROSELLA results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer,” said Alexander B. Olawaiye, M.D., Director of gynecological cancer research at Magee-Women’s Hospital of the University of Pittsburgh and Principal Investigator in the ROSELLA trial. “Platinum-resistant ovarian cancer poses a significant treatment challenge. The ROSELLA results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes,” said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas University, Rozzano and investigator in the ROSELLA trial. “The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look forward to presenting the trial’s full results in the coming months. We expect to submit our NDA in the third quarter and our MAA shortly thereafter.” The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG). About Relacorilant Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. About Platinum-Resistant Ovarian Cancer Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have “platinum-resistant” disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe. About Corcept’s Oncology Programs Cortisol helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response, which weakens its ability to fight disease. About Corcept Therapeutics For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators and GR antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com . SOURCE: Corcept Therapeutics

Clinical ResultOrphan DrugPhase 3Drug Approval

31 Mar 2025

·www.fiercebiotech.com

Corcept\'s investigational oral therapy cuts ovarian cancer progression by 30%, teeing up FDA filing

Corcept Therapeutics plans to use the full data set to request market approval from U.S. regulators in the third quarter.\n Corcept Therapeutics’ oral antiglucocorticoid plus chemotherapy slashed risk of ovarian cancer progression by 30% compared to chemotherapy alone. The biopharma intends to take the phase 3 data to regulators in hopes of delivering a new standard of care for patients with platinum-resistant cancer.The California-based company’s stock has skyrocketed 85% since Friday’s market close, climbing from $54.60 per share to $101 as of 10:30 a.m. ET today.The top-line results come from Corcept’s pivotal late-stage trial, dubbed Rosella, which recruited 381 patients with platinum-resistant ovarian cancer. Participants were randomized to receive either Corcept’s antiglucocorticoid relacorilant alongside nab-paclitaxel (sold as Abraxane), or nab-paclitaxel alone.The trial measured two primary endpoints—progression-free survival, as evaluated by a blinded independent central review (PFS-BICR), and overall survival (OS)—with a win achieved if either were met, according to Corcept. It was on progression-free survival where Corcept claimed a win, with patients treated with relacorilant and chemotherapy experiencing a median PFS-BICR of 6.5 months compared to 5.5 months for patients who received nab-paclitaxel alone, representing a statistically significant 30% reduction.An interim evaluation found a significant improvement for OS in patients receiving the investigational combo, with a median OS of 16 months compared to 11.5 months for patients receiving only nab-paclitaxel. The full data set was not shared, with complete findings expected to be presented at a medical conference later this year, according to the biopharma. No new safety signals related to relacorilant were reported, and the therapy was well tolerated, according to Corcept. The company plans to use the full data set to request market approval from U.S. regulators in the third quarter of this year, with a European ask to follow, Corcept Chief Development Officer Bill Guyer said in a March 31 release. Relacorilant, an oral therapy, is a selective glucocorticoid receptor antagonist designed to modulate cortisol activity by binding to the receptor while avoiding other hormone receptors.“Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies,” Alexander Olawaiye, M.D., director of gynecological cancer research at Magee-Womens Hospital of the University of Pittsburgh and principal investigator for Rosella, said in the release. “The Rosella results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer.”Corcept is studying relacorilant in multiple indications, including endogenous hypercortisolism, a hormonal disorder also known as Cushing’s syndrome in which the drug has snagged FDA orphan drug designation.In May 2024, the biopharma reported a phase 3 win for the antiglucocorticoid in Cushing’s, with a new drug application submitted to the FDA in the indication earlier this month. A decision is expected by or before Dec. 30 of this year.

$Corcept\'s investigational oral therapy cuts ovarian cancer progression by 30%, teeing up FDA filing$

Phase 3Clinical ResultOrphan Drug

31 Mar 2025

·endpts.com

Corcept shares soar after Phase 3 win in platinum-resistant ovarian cancer

Corcept Therapeutics’ oral glucocorticoid receptor antagonist has improved survival outcomes in a late-stage test in patients with a challenging form of ovarian cancer, sending its shares up 76% at market open on Monday. The California biotech’s candidate, dubbed relacorilant — given together with nab-paclitaxel chemotherapy — slashed the risk of disease progression by 30% compared with nab-paclitaxel alone, according to a Monday release . This level of risk reduction is statistically significant, Corcept said. The treatment arm also hit 6.5 months of median progression-free survival versus 5.5 months for control. Relacorilant could become the new standard of care if greenlit for platinum-resistant disease, chief development officer Bill Guyer said in the release. The current standard of care in this setting is systemic chemotherapy. In the subset of ovarian cancer patients with tumors that test positive for FRα, AbbVie’s targeted therapy Elahere is also an option. Corcept’s Phase 3 ROSELLA study enrolled 381 patients with platinum-resistant ovarian cancer across several locations, including the US and Europe. The patients did not undergo biomarker selection. The trial measured the dual primary endpoints of PFS and overall survival. In the latter endpoint, patients treated with relacorilant lived for an average of 16 months, compared with 11.5 months for the control arm. Safety results were similar between both arms, the company reported. Corcept said it will share full results from ROSELLA at an upcoming medical conference. It is also planning to file for FDA approval in the third quarter, with an EU submission to follow shortly thereafter. Relacorilant is designed to regulate cortisol activity by selectively binding to the glucocorticoid receptor while avoiding interaction with other hormone receptors, according to Corcept. The drug’s success in ovarian cancer marks a welcome turn of events after it failed to significantly improve systolic blood pressure versus placebo last year in patients with Cushing’s syndrome enrolled in a Phase 3 trial. But relacorilant did significantly improve blood pressure compared with patients’ baseline levels. It also passed a separate registrational test in Cushing’s syndrome, spurring the company to file an NDA . Corcept expects a decision by Dec. 30. The company is also evaluating the drug in combination with Pfizer and Astellas’ Xtandi in a Phase 2 prostate cancer trial. In December, Corcept’s other candidate, dazucorilant, failed a mid-stage trial in ALS.

Phase 3Phase 2Clinical Result

100 Deals associated with Relacorilant

External Link

KEGG	Wiki	ATC	Drug Bank
D11336	Relacorilant	-	DB14976

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cushing Syndrome	NDA/BLA	United States	Corcept Therapeutics, Inc.	30 Dec 2024
Endogenous Cushing Syndrome	Phase 3	Italy	Corcept Therapeutics, Inc.	15 Nov 2018
Endogenous Cushing Syndrome	Phase 3	Netherlands	Corcept Therapeutics, Inc.	15 Nov 2018
Endogenous Cushing Syndrome	Phase 3	Canada	Corcept Therapeutics, Inc.	15 Nov 2018
Endogenous Cushing Syndrome	Phase 3	Spain	Corcept Therapeutics, Inc.	15 Nov 2018
Endogenous Cushing Syndrome	Phase 3	Israel	Corcept Therapeutics, Inc.	15 Nov 2018
Endogenous Cushing Syndrome	Phase 3	Austria	Corcept Therapeutics, Inc.	15 Nov 2018
Endogenous Cushing Syndrome	Phase 3	United States	Corcept Therapeutics, Inc.	15 Nov 2018
Endogenous Cushing Syndrome	Phase 3	Bulgaria	Corcept Therapeutics, Inc.	15 Nov 2018
Endogenous Cushing Syndrome	Phase 3	Poland	Corcept Therapeutics, Inc.	15 Nov 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03776812 (CTgov)	Phase 2	Recurrent Platinum-Resistant Primary Peritoneal Carcinoma \| Recurrent ovarian cancer \| Recurrent Primary Peritoneal Carcinoma \| Fallopian Tube Carcinoma	178	Nab-paclitaxel+Relacorilant (Arm A: Continuous Relacorilant Dosing)	(rvjkeqpofp) = mpbhqkjvmy kwhzlxgpxa (drbbxodsmo, jvanwxzzyb - mukqmhzorb) View more	-	30 Apr 2025
				Nab-paclitaxel+Relacorilant (Arm B: Intermittent Relacorilant Dosing)	(rvjkeqpofp) = splyqqhiuf kwhzlxgpxa (drbbxodsmo, ekhwutroqu - bvxfinalmf) View more
NCT03697109 (GRACE, CTgov)	Phase 3	Endogenous Cushing Syndrome	152	Relacorilant (Relacorilant (RW Phase))	(junhcvsljn) = obvtngqjrv yepofzawwh (etdnfgmyiv, prmntsutbw - rriklabtam) View more	-	24 Apr 2025
				Placebo (Placebo (RW Phase))	(junhcvsljn) = swhfclskph yepofzawwh (etdnfgmyiv, hqlgselwnx - ukajimsqvt) View more
NCT05257408 (ROSELLA, Company_Website) Manual	Phase 3	Platinum-Resistant Ovarian Carcinoma	381	Relacorilant + nab-paclitaxel	(ytvbpcxxdz) = toowxggwvz smefddpiyz (rmzjuydnmj ) Met View more	Positive	31 Mar 2025
				Nab-paclitaxel	(ytvbpcxxdz) = cllqlakumy smefddpiyz (rmzjuydnmj ) Met View more
NCT03604198 (BusinessWire) Manual	Phase 3	Cushing Syndrome	116	Relacorilant	(gowbpvbvvv) = At month 24 of the study, patients exhibited clinically meaningful and statistically significant reductions in mean systolic blood pressure (10.0 mm Hg; p-value: 0.012) and mean diastolic blood pressure (7.3 mm Hg; p-value: 0.016), compared to their measurement at entry into the long-term extension study. plndchwvyl (xfhvhavfho ) View more	Positive	16 Dec 2024
NCT03604198 (Company_Website) Manual	Phase 2	Cushing Syndrome	53	Relacorilant	(pxcvizklwq) = iuhekdcfjw gdqdtbpiqn (uaulevaqsq ) View more	Positive	25 Nov 2024
NCT04308590 (GRADIENT, Biospace) Manual	Phase 3	Cushing Syndrome	137	relacorilant	(pjfdpibuks) = exfaaajpey pnndnutmxz (kywalltydb ) Met	Positive	30 Oct 2024
				Placebo	(pjfdpibuks) = zkameroaxb pnndnutmxz (kywalltydb ) Met
NCT02804750 \| NCT00280475 (Pubmed \| J Endocrinol Invest)	Phase 2	Cushing Syndrome factor VIII \| activated partial thromboplastin time \| platelet count ... View more	34	Relacorilant (Surgery)	(zzilelkqvp) = wkbppzujzs ikgizrmqzu (drhtkglzmw )	Positive	21 Sep 2024
NCT03697109 (GRACE, ENDO2024)	Phase 3	Cushing Syndrome	152	Relacorilant 100 mg QD	emgzxglotq(xeigqcmfru) = ocbaqeqroz dxkharegaq (ciktikpxvv, 6.7) View more	Positive	01 Jun 2024
NCT03697109 (GRACE, Company_Website) Manual	Phase 3	Cushing Syndrome	-	relacorilant	(nwrofgxxiu) = GRACE met its primary endpoint of loss of blood pressure control in the randomized withdrawal phase among patients receiving relacorilant as compared to placebo bsnphhmpgc (xepuflqkvp ) Met View more	Positive	28 May 2024
				placebo
NCT03697109 (GRACE, GlobeNewswire) Manual	Phase 3	Endogenous Cushing Syndrome	152	relacorilant	(ffedlxekhq) = aauqojtdur hhuxvsajxx (qgoqfngump ) View more	Positive	22 Apr 2024
				relacorilant (withdrawal phase)	(ffedlxekhq) = rzdnanaeea hhuxvsajxx (qgoqfngump ) View more

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