A Randomized, Controlled, Open-Label Phase 3 Study of Melflufen in Combination With Daratumumab Compared With Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma

This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with Relapsed-Refractory Multiple Myeloma (RRMM) who were either double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or had received at least 3 prior lines of therapy including an IMiD and a PI.
Patients received treatment with melflufen+dexamethasone+daratumumab or daratumumab until documented progressive disease, unacceptable toxicity, or patient/treating physician decision. Patients in the daratumumab treatment arm had the option to receive treatment with melflufen+dexamethasone+daratumumab after confirmed progressive disease.

Start Date21 Dec 2020

Sponsor / Collaborator

Oncopeptides AB

EUCTR2019-004127-21-BG / Not yet recruitingPhase 2

A randomized, two-period, cross-over, Phase 2 study, comparing thepharmacokinetics, and assessing safety and tolerability of peripheral and central intravenous administration of melflufen in patients with relapsed and refractory multiple myeloma. - PORT study

Start Date08 May 2020

Sponsor / Collaborator

Oncopeptides AB

EUCTR2018-002761-19-PL / Not yet recruitingPhase 2

An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy

Start Date24 Oct 2019

Sponsor / Collaborator

Oncopeptides AB

100 Clinical Results associated with Melphalan Flufenamide

100 Translational Medicine associated with Melphalan Flufenamide

100 Patents (Medical) associated with Melphalan Flufenamide

Literatures (Medical) associated with Melphalan Flufenamide

01 Feb 2024·Journal of clinical pharmacology

Pharmacokinetics and Metabolism of Melflufen, an Alkylating Peptide–Drug Conjugate, in Patients with Relapsed Refractory Multiple Myeloma

Article

Author: Gullbo, Joachim ; Pekar, David ; Sjöberg, Per ; Huledal, Gunilla ; Kawakatsu, Sonoko ; Norin, Stefan ; Jerling, Markus ; Ruiz-Garcia, Ana ; Wang, Xiaoning

Abstract:

Melphalan flufenamide (melflufen) is a novel lipophilic peptide–drug conjugate recently approved in the European Union and the United Kingdom for the treatment of relapsed refractory multiple myeloma. Melflufen rapidly crosses the cell membrane, and inside tumor cells, melflufen utilizes peptidases and esterases to release entrapped hydrophilic metabolites with alkylating activity. In vitro, in whole blood, melflufen was rapidly distributed into blood cells and quickly converted to its main metabolite melphalan, with maximum cellular concentrations of noncovalently bound melflufen and melphalan after 1 and 6 minutes, respectively. Melphalan outflow from blood cells was slow, with peak concentrations in plasma after 25 minutes. The pharmacokinetics of melflufen was best described by a 2‐compartment model. Following a 30‐minutes intravenous infusion of 40 mg in 27 patients with relapsed refactory multiple myeloma, mean half‐life in the α phase of the curve was 1.24 minutes, half‐life in the β phase of the curve 26.7 minutes, and clearance 13.4 L/min. Desethyl‐melflufen exposure was below 20% compared to melflufen. Based on population analysis (298 patients with relapsed refactory multiple myeloma), the melphalan pharmacokinetics were well characterized by a 3‐compartment model with melflufen dosing into a peripheral compartment, assuming instantaneous distribution of melflufen into cells and subsequent rapid metabolism to melphalan. Mean clearance and central and deep peripheral volumes of distribution were 22.4 L/h, 2.70 L, and 51.3 L, respectively. Clearance increased and maximum concentration decreased with increasing body weight and estimated glomerular filtration rate. In conclusion, melflufen administration differs from melphalan administration by a more rapid distribution into cells, which, in conjunction with a rapid intracellular metabolism, allows for higher maximum concentrations of alkylating agents, and by a more extensive distribution of melphalan to peripheral tissues.

01 Jan 2024·Transplantation and cellular therapy

Reduced-Intensity Compared to Nonmyeloablative Conditioning in Patients with Non-Hodgkin Lymphoma Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Article

Author: Brown, Samantha ; Dahi, Parastoo B ; Shah, Gunjan ; Nath, Karthik ; Barker, Juliet ; Giralt, Sergio ; Jakubowski, Ann ; Perales, Miguel-Angel ; Rodriguez, Natasia ; Papadopoulos, Esperanza ; Gyurkocza, Boglarka ; Devlin, Sean ; Sauter, Craig ; Peterson, Kristen ; Scordo, Michael ; Ponce, Doris ; Lin, Andrew

Reduced-intensity conditioning (RIC) and nonmyeloablative (NMA) conditioning are preferred for patients with non-Hodgkin lymphoma (NHL) undergoing allogeneic hematopoietic stem cell transplantation (allo-HCT). Although prior studies have suggested that higher-intensity regimens in RIC-NMA conditioning are associated with inferior outcomes in patients with NHL, the optimal conditioning regimen remains unknown. We performed a retrospective single-center analysis to determine outcomes of adult patients with B cell and T cell NHL who underwent allo-HCT and received either RIC or NMA conditioning between March 2008 and December 2019. RIC regimens included fludarabine-cyclophosphamide-thiotepa-4 Gy-total body irradiation (Flu-Cy-TT-4Gy-TBI), fludarabine-melphalan (Flu-Mel), fludarabine-cyclophosphamide-4 Gy-total body irradiation (Flu-Cy-4Gy-TBI), and fludarabine-busulfan-4 (Flu-Bu-4). The NMA regimen comprised fludarabine-cyclophosphamide-2 Gy-total body irradiation (Flu-Cy-2Gy-TBI). The primary outcome was overall survival (OS); secondary outcomes included progression-free survival (PFS), nonrelapse mortality (NRM), and the incidence of acute and chronic graft-versus-host-disease (GVHD). Of 279 transplants recipients (median age, 58 years), 110 received RIC (55% Flu-Mel, 38% Flu-Cy-TT-4Gy-TBI, 6% Flu-Bu-4, 1% Flu-Cy-4Gy-TBI) and 169 received NMA conditioning with Flu-Cy-2Gy-TBI. With a median of 64 months of follow-up post-allo-HCT, there was no significant difference in OS between the NMA and RIC groups (median, not reached [NR] versus 103 months; P = .1), and this was maintained on multivariable analysis. Similarly, after adjustment for all independently significant covariates (age, Karnofsky Performance Status [KPS], Hematopoietic Cell Transplantation Comorbidity Index [HCT-CI], and disease histology), the regression analysis showed no significant difference in PFS with RIC compared to NMA conditioning (hazard ratio [HR] 1.38; 95% confidence interval [CI], .92 to 2.09; P = .24). On univariable analysis, there was no significant difference in NRM between the RIC and NMA arms (100-day estimate, 10.0% versus 1.8%; P = .5). After adjustment for age, ethnicity, KPS, HCT-CI, GVHD prophylaxis, and donor source, RIC conditioning was associated with a significantly higher incidence of NRM compared to NMA conditioning (HR, 2.61; 95% CI, 1.04 to 6.52; P = .039). On multivariable analysis, compared with the NMA arm, the RIC arm had higher rates of grade II-IV (HR, 2.25; 95% CI, 1.31 to 3.86; P = .002) and grade III-IV acute GVHD (HR, 5.62; 95% CI, 2.03 to 15.6; P < .001). The findings of this study suggest that NMA conditioning with Flu-Cy-TBI-2Gy may be considered over more intensive RIC regimens for patients with NHL undergoing allo-HCT.

01 Jan 2024·International journal of hematology

Fludarabine melphalan versus fludarabine treosulfan for reduced intensity conditioning regimen in allogeneic hematopoietic stem cell transplantation: a retrospective analysis

Article

Author: Bagal, Bhausaheb ; Kannan, Sadhana ; Mirgh, Sumeet ; Nayak, Lingaraj ; Chichra, Akanksha ; Mathew, Libin ; Gokarn, Anant ; Khattry, Navin ; Kalantri, Siddhesh ; Kothari, Rushabh ; Jindal, Nishant ; Bonda, Avinash ; Punatar, Sachin

Various reduced-intensity conditioning (RIC) regimens are used to decrease toxicity while providing comparable outcomes to myeloablative regimens. We compared toxicity and outcomes between two RIC regimens, fludarabine with melphalan (Flu-Mel) and fludarabine with treosulfan (Flu-Treo), retrospectively over a 10-year period in two donor groups, matched related donor (MRD)/matched unrelated donor (MUD) and haploidentical (Haplo) transplants. The study included 138 patients, of which 105 received MRD/MUD (Flu-Mel: 94, Flu-Treo: 11) and 33 Haplo (Flu-Mel: 17, Flu-Treo: 16) transplants. In the MRD/MUD group, 44 (47%) of patients who received Flu-Mel had grade 3/4 oral mucositis compared to 1 (9%) who received Flu-Treo (P = 0.02). Corresponding numbers in the Haplo group were 7 (41%) and 1 (6%). Grade 3/4 diarrhoea was more frequent with Flu-Mel than Flu-Treo in the Haplo group (41% vs 6%; P = 0.039), but not the MRD/MUD group. Median follow-up time for all patients was 4.8 years. Five-year OS in the MRD/MUD group was 62% with Flu-Mel versus 53% with Flu-Treo (P = 0.0694). Similarly, 5-year OS was 41% with Flu-Mel and 28% with Flu-Treo (P = 0.770) in the Haplo group. Severe mucositis and diarrhoea were significantly less frequent with Flu-Treo than Flu-Mel. Flu-Treo provided comparable outcomes to Flu-Mel in all donor transplants.

News (Medical) associated with Melphalan Flufenamide

27 Jun 2024

·pipelinereview.com

Oncopeptides selects first candidate drug from its SPiKE platform

STOCKHOLM, Sweden I June 27, 2024 I Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, today announces that the first candidate drug based on the company´s unique platform for Small Polypeptide based innate Killer Engagers (SPiKE) has been selected. The SPiKE platform uses multi-specific constructs, able to bind to multiple targets simultaneously. The first drug candidate, OPSP1, is a bi-specific construct designed to both engage natural killer cells, a type of immune cell, and target cancer cells. The goal of OPSP1 is to prove the ability of the SPiKE platform to activate these natural killer cells. To do this, OPSP1 targets a specific protein called BCMA that is expressed in some cancers including multiple myeloma. By targeting this protein, Oncopeptides will be able to assess how well the SPiKE platform can activate natural killer cells to fight cancer, a crucial step before continued clinical development of the SPiKE platform. “There is significant potential in NK cell-mediated therapy for difficult-to-treat cancers,” says Dr. Karl-Johan Malmberg, professor at Oslo University and Karolinska Institutet. ”Despite the substantial advancements in current treatments, the reality is that resistance to these therapies often develops. This underscores the urgent need for new and innovative treatment options to address this unmet medical need.” NK cell-mediated therapy represents a promising avenue in cancer immunotherapy, with ongoing research aimed at overcoming existing challenges and enhancing its therapeutic potential. As a next step for Oncopeptides, a first-in-human clinical trial will be designed to evaluate the safety, efficacy, and overall therapeutic potential of OPSP1. “The ability to show a promising product pipeline behind its flagship product is important for a growing biotech company. Following the accomplishments we have seen with our first technology platform PDC, where we have an approved product, we are excited to also announce progress with SPiKE, our second technology platform,” says Sofia Heigis, CEO of Oncopeptides. “This milestone is a major step forward in our ambition to ensure that Oncopeptides can continue to provide hope for patients suffering from difficult-to-treat cancers, and value to shareholders investing in our science.” A pre-clinical project for the SPiKE platform has received a financial grant from the Eurostars 3-program, co-financed by the European Union research and innovation program “Horizon Europe” and is driven by an international research consortium that includes world-leading expertise from the department of Cancer Immunology at Oslo University Hospital, Pharmatest Services Ltd in Turku, Finland and the Royal Institute of Technology in Stockholm (KTH), from where the technology originally stems. With this grant, Sweden’s Innovation Agency, Vinnova, has provided Oncopeptides resources to develop pre-clinical proof of concept for a novel synthetic small polypeptide for the treatment of multiple myeloma. For more information, including questions and answers for investors and additional details on the SPiKE platform, please visit our website . About Oncopeptides Oncopeptides is a biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers. The company uses its proprietary Peptide Drug Candidate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Pepaxti® (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. Oncopeptides is developing several new compounds based on its proprietary technology platforms and is listed on Nasdaq Stockholm with the ticker ONCO. For more information see: www.oncopeptides.com SOURCE: Oncopeptides

Clinical StudyDrug ApprovalImmunotherapyPDC

27 Mar 2024

·endpts.com

Oncopeptides joins up with Vector to commercialize blood cancer drug Pepaxto in the Middle East, North Africa

About a month after Oncopeptides lost its appeal with the FDA to continue the approval for Pepaxto in multiple myeloma patients, the company announced it’s teaming up with Vector Pharma to commercialize the drug in the Middle East and North Africa. Vector will distribute the drug, marketed as Pepaxti outside of the US, in the region, which includes Saudi Arabia, Qatar, the United Arab Emirates, Bahrain, Kuwait, Oman, Algeria, Tunisia, Morocco, Libya, Lebanon and Iraq. The companies are splitting the revenues while Vector will take on all of the costs. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

Drug ApprovalLicense out/inAccelerated Approval

27 Mar 2024

·www.globenewswire.com

Oncopeptides and Vector Pharma FZCO Announce Collaboration to Provide Pepaxti to Patients in the Middle East and North Africa

DUBAI, United Arab Emirates and STOCKHOLM, Sweden, March 27, 2024 (GLOBE NEWSWIRE) -- Oncopeptides AB (STO: ONCO), a biotech company focused on difficult-to-treat cancers, and Vector Pharma FZCO (“Vector”) today announced a collaboration to commercialize Oncopeptides’ flagship drug Pepaxti (melphalan flufenamide) in the Middle East and North Africa (“MENA”) countries of Saudi Arabia, Qatar, UAE, Bahrain, Kuwait, Oman, Algeria, Tunisia, Morocco, Libya, Lebanon, and Iraq. Under the terms of this exclusive agreement, Vector will distribute Pepaxti to patients in the MENA region for the treatment of patients with multiple myeloma. The two parties have agreed on a revenue split on all Pepaxti sales in the region, with Vector carrying all costs through their existing structure in the region. All sales will be made on a named patient basis, meaning doctors request supply of Pepaxti directly from the manufacturer, a method of sales similar to that being employed by Oncopeptides in Greece. “I am excited to announce this regional agreement with Oncopeptides,” says Vector Pharma FZCO Managing Partner Patrick Jordan. “Mutliple Myeloma continues to be a difficult hematological disease that requires a host of therapies to fight back against the disease. In offering Pepaxti, a drug that is fully approved in the EU, to Health Care Providers in the MENA region, they will now have an important and complementing tool in the arsenal to help treat patients in need.” Vector is a leading distributor of drugs against rare diseases in the MENA region, and also a founding member of the World Orphan Drug Alliance, WODA, providing services required for commercialization of orphan drugs in 152 countries on 6 continents. “Providing Pepaxti to patients also outside of Europe is an important value driver for Oncopeptides, and our partnership with Vector, being a member of the World Orphan Drug Alliance, is an important step forward that we believe has the potential to create additional value for both patients and our shareholders,” says Sofia Heigis, CEO of Oncopeptides. “We are happy for our partnership with Vector and look forward to working together as we enter this promising region together. Through their alliance with WODA, this partnership also has the potential to unlock additional geographies in the future, something which is currently under discussion.” Oncopeptides uses its proprietary Peptide Drug Candidate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Pepaxti is a medicine used to treat adults with multiple myeloma (a cancer of the bone marrow) when the cancer has not responded to previous treatments (refractory). It is used in combination with dexamethasone (an anti-inflammatory medicine) in adults who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti‑CD38 antibody, and whose disease has worsened since the last treatment. About Vector Pharma FZCO Vector Pharma was founded in 2019 with the ambition to be the leading full service distributor for rare diseases, oncology and highly specialized therapeutics in the Middle East, North Africa, and Turkish markets. As the only Trace certified full service distributor in the region, Vector has an equal emphasis on patient demand generation through evidence-based medicine, fast track market access solutions, and highest compliance & ethical standards, all the while striving for the best outcomes for patients, prescribers, and partners. Vector Pharma is also a proud founding member of the World Orphan Drug Alliance (WODA) offering its services together with like-minded sister companies in Switzerland, CEE, Russia & CIS, Israel, Greece/Cyprus/Malta, Africa, Greater China, SE Asia & ANZ, Japan/South Korea and Latin America. More information can be found at www.vectorpharma.me or at custops@vectorpharma.me About Oncopeptides Oncopeptides is a biotech company focused on research, development, and commercialization of therapies for difficult-to-treat hematological diseases. The company uses its proprietary Peptide Drug Candidate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Pepaxti® (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. Oncopeptides is developing several new compounds based on its proprietary technology platforms and is listed on Nasdaq Stockholm with the ticker ONCO. For more information see: www.oncopeptides.com

License out/inOrphan DrugPDCDrug ApprovalFast Track

100 Deals associated with Melphalan Flufenamide

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KEGG	Wiki	ATC	Drug Bank
D11865	-	L01XX	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Myeloma	US	Oncopeptides AB	26 Feb 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Relapse multiple myeloma	Phase 3	BG	Oncopeptides AB	21 Dec 2020
Relapse multiple myeloma	Phase 3	CZ	Oncopeptides AB	21 Dec 2020
Relapse multiple myeloma	Phase 3	GE	Oncopeptides AB	21 Dec 2020
Relapse multiple myeloma	Phase 3	DE	Oncopeptides AB	21 Dec 2020
Relapse multiple myeloma	Phase 3	GR	Oncopeptides AB	21 Dec 2020
Relapse multiple myeloma	Phase 3	NO	Oncopeptides AB	21 Dec 2020
Relapse multiple myeloma	Phase 3	PL	Oncopeptides AB	21 Dec 2020
Relapse multiple myeloma	Phase 3	RU	Oncopeptides AB	21 Dec 2020
Relapse multiple myeloma	Phase 3	RS	Oncopeptides AB	21 Dec 2020
Relapse multiple myeloma	Phase 3	ES	Oncopeptides AB	21 Dec 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


OCEAN (OP-103) (ASH2023)	Phase 3	Plasma cell myeloma refractory	495	Melflufen 40 mg	mhudphoypa(zbgrbqmjxf) = kourtjzxjo vnktywwurb (ecjypufptf )	-	09 Dec 2023
				Pomalidomide 4 mg	mhudphoypa(zbgrbqmjxf) = dgruneeicq vnktywwurb (ecjypufptf )
NCT04649060 (LIGHTHOUSE, IMS2023)	Phase 3	Multiple Myeloma	54	Melflufen + Daratumumab + Dexamethasone	lswjxszyrk(hyqvenjjrv) = bsyquuazbm mxdrwkmixj (vdbffytloe ) View more	Positive	26 Sep 2023
				Daratumumab	lswjxszyrk(hyqvenjjrv) = qlthgvyptn mxdrwkmixj (vdbffytloe ) View more
Anchor (OP?104) (IMS2023)	Not Applicable	Relapse multiple myeloma \| Plasma cell myeloma refractory	-	Melflufen + Vd	uyibgsjksy(ozqvedbufx) = cxvzkblvbz dnhbsgafxs (ltvjwodadr ) View more	-	26 Sep 2023
				Melflufen + Dd	uyibgsjksy(ozqvedbufx) = ectznjpnsr dnhbsgafxs (ltvjwodadr ) View more
NCT03639610 (CTgov)	Phase 2	Plasma cell myeloma refractory	35	Melflufen (Cohort 1a, Melflufen 40 mg)	pnnchvkqyg(gqeaogncbw) = dsjnmdiwjg xbjdervyzj (ubowtkmnlv, bffpniassg - bqugztfncp) View more	-	09 Mar 2023
				Melflufen (Cohort 1b, Melflufen 30 mg)	pnnchvkqyg(gqeaogncbw) = dolzkkbgwu xbjdervyzj (ubowtkmnlv, clspjnejoc - rqyisswbhq) View more
NCT03151811 (OCEAN, CTgov)	Phase 3	Multiple Myeloma	495	Melflufen+Dexamethasone (Arm A: Melflufen+Dexamethasone)	stkwqmguyu(xtzawiquud) = ssraustryi caubxeopba (njegsngbht, unvmdyhuyr - lpeijgzzmn) View more	-	27 Jul 2022
				pomalidomide+Dexamethasone (Arm B: Pomalidomide+Dexamethasone)	stkwqmguyu(xtzawiquud) = txegsdrkkc caubxeopba (njegsngbht, reipnuupmn - ypqrgvljkh) View more
NCT03151811 (OCEAN, Pubmed \| Lancet Haematol) Manual	Phase 3	Multiple Myeloma	495	Dexamethasone+Melflufen	xysbvajogp(nqtxaoyzie) = jlqfqwfpes tqgladdwac (gmlomhwkhz ) View more	Superior	01 Feb 2022
				Dexamethasone+Pomalidomide	xysbvajogp(nqtxaoyzie) = vbtsibgiit tqgladdwac (gmlomhwkhz ) View more
NCT03481556 (ANCHOR, EHA2021)	Phase 1/2	Relapse multiple myeloma	13	Melflufen 30 mg	ikpklrroxb(yqwoqjfomp) = jlevesqrjv aanrsfjbvs (vdougujzaa ) View more	-	09 Jun 2021
				Melflufen 40 mg	ikpklrroxb(yqwoqjfomp) = uaamknflcu aanrsfjbvs (vdougujzaa ) View more
O-12-M1 and HORIZON (EHA2021)	Not Applicable	Relapse multiple myeloma	202	Melflufen 40 mg plus dexamethasone 40 mg	hehrhicdxh(cvorwkzuqj) = dtmlnznmsf mzxsrnvytt (cshnovaowf, 29.1 - 70.9) View more	-	09 Jun 2021
EHA2021	Not Applicable	Myeloid Leukemia	-	Melflufen	mahxoxyhlj(vleilmkhad) = nfdwgvgucy xtkzmikivg (wsdenadkwk )	-	09 Jun 2021
				Cytarabine and Venetoclax	mahxoxyhlj(vleilmkhad) = qrvuvhnhpn xtkzmikivg (wsdenadkwk )
NCT01897714 \| NCT02963493 (NA, ASCO2021)	Not Applicable	Multiple Myeloma	202	Melflufen plus dex	brixfrixcm(vnmtbtbvyv) = azztzpxzow tbaxbkwzzl (malldiyeel )	Positive	28 May 2021
				Placebo	brixfrixcm(vnmtbtbvyv) = gzcxtqzcqb tbaxbkwzzl (malldiyeel )

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