Somebody Call Me A Doctor...........Champions Of Imetelstat

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kmall
Posts: 755
Joined: Thu Mar 21, 2019 3:57 pm

Somebody Call Me A Doctor...........Champions Of Imetelstat

Post by kmall » Sun Apr 03, 2022 8:19 am

Dr Aleksandra Rizo (USA): P3 IMerge (MDS) / P3 IMpact (MF)
https://www.geron.com/about/management/
Specified Indications: MDS, AML, MF, MCL, MM
Geron Executive VP Chief Medical Officer
Geron Abstracts/Affiliations:
1 – (2017) Telomerase inhibitor imetelstat in combination with the BCL-2 inhibitor venetoclax enhances apoptosis in vitro and increases survival in vivo in acute myeloid leukemia
Joshua J. Rusbuldt, Leopoldo Luistro, Diana Chin, Melissa Smith, Amy Wong, Margarita Romero, Aleksandra Rizo, Jacqueline Bussolari, Kate Sasser, Fei Huang Janssen Research & Development
https://www.geron.com/file.cfm/53/docs/ ... R-2017.pdf

2 – (2017) Efficacy and Safety of Imetelstat in RBC Transfusion-Dependent (TD) IPSS Low/Int-1 MDS Relapsed/Refractory to Erythropoiesis-Stimulating Agents (ESA) (IMerge)
Pierre Fenaux, Azra Raza, Edo Vellenga, Uwe Platzbecker, Valeria Santini, Irina Samarina, Koen Van Eygen, María Díez-Campelo, Mrinal M. Patnaik, Laurie Jill Sherman, Libo Sun, Helen Varsos, Esther Rose, Aleksandra Rizo, David P. Steensma
https://www.geron.com/file.cfm/53/docs/ ... H-2017.pdf

3 – (2019) Favorable Overall Survival of Imetelstat-treated Relapsed/Refractory Myelofibrosis Patients Compared with Closely Matched Real World Data.
Andrew Kuykendall, Ying Wan, John Mascarenhas, Jean-Jacques Kiladjian, Alessandro Vannucchi, Julia Wang, Qi Xia, Eugene Zhu, Faye Feller, Aleksandra Rizo, Jacqueline Bussolari, Rami Komrokji
https://www.geron.com/r-d/publications/



Dr Azra Raza (USA): P3 IMerge (MDS) – Imetelstat
https://www.cancer.columbia.edu/profile/azra-raza-md
Specified Indications: MDS, AML
P3 Site location: Columbia University Medical Center and Columbia Presbyterian – New York, NY
Geron Abstracts/Affiliations:
1 – (2021) Imetelstat Achieves Meaningful and Durable Transfusion Independence in High Transfusion-Burden Patients With Lower-Risk Myelodysplastic Syndromes in a Phase II Study
David P Steensma, Pierre Fenaux , Koen Van Eygen , Azra Raza , Valeria Santini , Ulrich Germing , Patricia Font , Maria Diez-Campelo , Sylvain Thepot , Edo Vellenga , Mrinal M Patnaik , Jun Ho Jang , Helen Varsos , Jacqueline Bussolari , Esther Rose , Laurie Sherman , Libo Sun , Ying Wan , Souria Dougherty , Fei Huang , Faye Feller , Aleksandra Rizo , Uwe Platzbecker

https://pubmed.ncbi.nlm.nih.gov/33108243/

2 – (2018) Imetelstat in RBC Transfusion‐Dependent Lower Risk MDS Relapsed/Refractory to Erythropoiesis‐Stimulating Agents (IMerge): Updated Efficacy and Safety
Pierre Fenaux, Azra Raza, Edo Vellenga, Uwe Platzbecker, Valeria Santini, Irina Samarina, Koen Van Eygen, María Díez‐Campelo, Mrinal M. Patnaik, Laurie Jill Sherman, Libo Sun, Helen Varsos, Esther Rose, Aleksandra Rizo, David P. Steensma
https://www.geron.com/file.cfm/53/docs/ ... A-2018.pdf



Dr Pierre Fenaux (France): P3 IMerge (MDS)
https://www.iacrlrd2021.com/team-member/pierre-fenaux/
Specified Indications: MDS, AML, APL
P3 Site Location: CHU – HA’pital Saint Louis-H – Paris, France
Geron Abstracts/Affiliations:
1 – (2019) Treatment with Imetelstat Provides Durable Transfusion Independence in Heavily Transfused Non-del(5q) Lower Risk MDS Relapsed/Refractory to Erythropoiesis Agents.
Pierre Fenaux, David P. Steensma, Koen Van Eygen, Azra Raza, Valeria Santini, Ulrich Germin, Patricia Font, Maria Diez-Campelo, Sylvain Thepot, Edo Vellenga, Mrinal M. Patnaik, Jun Ho Jang, Laurie Sherman, Libo Sun, Helen Varsos, Aleksandra Rizo , Ying Wan, Fei Huang, Jacqueline Bussolari, Esther Rose, Uwe Platzbecker
https://www.geron.com/file.cfm/53/docs/ ... 0FINAL.pdf




Dr Valeria Santini (ITALY): P3 IMerge (MDS)
https://www.aamds.org/bio/valeria-santini-md
Specified Indications: MDS, AML, CML, PNH
P3 Site Location: Azienda Ospedaleria Universitaria Careggi di Firenze – Firenze, Italy
Geron Abstracts/Affiliations:
1 – (2017) Efficacy and Safety of Imetelstat in RBC Transfusion-Dependent (TD) IPSS Low/Int-1 MDS Relapsed/Refractory to Erythropoiesis-Stimulating Agents (ESA) (IMerge)
Pierre Fenaux, Azra Raza, Edo Vellenga, Uwe Platzbecker, Valeria Santini, Irina Samarina, Koen Van Eygen, María Díez-Campelo, Mrinal M. Patnaik, Laurie Jill Sherman, Libo Sun, Helen Varsos, Esther Rose, Aleksandra Rizo, David P. Steensma
https://www.geron.com/file.cfm/53/docs/ ... H-2017.pdf

2 – (2021) Imetelstat Achieves Meaningful and Durable Transfusion Independence in High Transfusion-Burden Patients With Lower-Risk Myelodysplastic Syndromes in a Phase II Study
David P Steensma, Pierre Fenaux, Koen Van Eygen, Azra Raza, Valeria Santini, Ulrich Germing, Patricia Font, Maria Diez-Campelo, Sylvain Thepot, Edo Vellenga, Mrinal M Patnaik, Jun Ho Jang, Helen Varsos, Jacqueline Bussolari, Esther Rose, Laurie Sherman, Libo Sun, Ying Wan, Souria Dougherty, Fei Huang, Faye Feller, Aleksandra Rizo, Uwe Platzbecker
https://ascopubs.org/doi/pdf/10.1200/JCO.20.01895



Dr Uwe Platzbecker (GERMANY): P3 IMerge (MDS)
https://www.aamds.org/bio/uwe-platzbecker-md
Specified Indications: MDS, AML, AA, MPN, PNH
P3 Site Location: University Hospital Leipzig – Leipzig, Germany
Geron Abstracts/Affiliations:
1 – (2019) IMerge: A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment. - Uwe Platzbecker, David P. Steensma, Koen Van Eygen, Azra Raza, Valeria Santini, Ulrich Germing, Patricia Font, Maria Diez-Campel, Sylvain Thepot, Edo Vellenga, Mrinal M. Patnaik, Jun Ho Jang, Laurie Sherman, Souria Dougherty, Libo Sun, Faye Feller, Ying Wan, Fei Huang, Aleksandra Rizo, Pierre Fenaux
https://www.geron.com/file.cfm/53/docs/ ... 202019.pdf

2 – (2021) Efficacy of Imetelstat is Independent of Molecular Subtypes in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA)
U.Platzbecker, P. Fenaux, K. V. Eygen, A. Raza, U. Germing, P. Font, M. Diez-Campelo, S. Thepot, E. Vellenga, M. M. Patnaik, J. H. Jang, L. Sherman, S. Dougherty, T. Berry, F. Feller, L. Sun, Y. Wan, A. Rizo, F. Huang, V. Santini
https://www.geron.com/file.cfm/53/docs/ ... Poster.pdf



Dr Edo Vellenga (Netherlands): P3 IMerge (MDS)
https://www.rug.nl/staff/e.vellenga/?lang=en
Specified Indications: AML, MDS
P3 Site Location: Universitair Medisch Centrum Groningen - Groningen, Netherlands
Geron Abstracts/Affiliations:
1 – (2020) IMerge: A Phase 3 Study to Evaluate Imetelstat in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) That Is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
Uwe Platzbecker, David P. Steensma, Koen Van Eygen, Azra Raza, Valeria Santini, Ulrich Germing, Patricia Font, Maria Diez-Campel, Sylvain Thepot, Edo Vellenga, Mrinal M. Patnaik, Jun Ho Jang, Laurie Sherman, Souria Dougherty, Libo Sun, Faye Feller, Ying Wan, Fei Huang, Aleksandra Rizo, Pierre Fenaux
https://www.researchgate.net/publicatio ... s-Stimulat



cont........

kmall
Posts: 755
Joined: Thu Mar 21, 2019 3:57 pm

Re: Somebody Call Me A Doctor...........Champions Of Imetelstat

Post by kmall » Sun Apr 03, 2022 8:25 am

Cont.......

Dr John Mascarenhas (USA): P3 IMpact (MF)
https://www.aamds.org/bio/john-mascarenhas-md
Specified Indications: MF, MDS, AML, CML, AA, MPN
P3 Site Location: Ichan School of Medicine at Mount Sinai – New York, NY
Geron Abstracts/Affiliations:
1 - (2018) Imetelstat Is Effective Treatment for Patients with Intermediate-2 or High-Risk Myelofibrosis Who Have Relapsed on or Are Refractory to Janus Kinase Inhibitor Therapy: Results of a Phase 2 Randomized Study of Two Dose Levels. John Mascarenhas, MD1 , Rami S. Komrokji2 , Michele Cavo, MD3 , Bruno Martino, MD4 , Dietger Niederwieser, MD5 , Andreas Reiter, MD6 , Bart L Scott, MD7 , Maria R. Baer, MD8 , Ronald Hoffman, MD9 , Olatoyosi Odenike, MD10 , Jacqueline Bussolari, PhD11, Eugene Zhu, PhD11, Fei Huang, PhD11, Esther Rose, MD11, Laurie Sherman, BSN11 , Souria Dougherty, BS, MBA11, Faye M. Feller, MD11 and Jean-Jacques Kiladjian, MD, PhD12
https://www.geron.com/file.cfm/53/docs/ ... _FINAL.pdf

2 – (2020) Potential Disease-Modifying Activity of Imetelstat Demonstrated By Reduction in Cytogenetically Abnormal Clones and Mutation Burden Leads to Clinical Benefits in Relapsed/Refractory Myelofibrosis Patients.
John Mascarenhas, MD, Rami S. Komrokji MD, Michele Cavo, MD, Bruno Martino, MD, Dietger Niederwieser, MD, Andreas Reiter, MD, Bart L Scott, MD, Maria R. Baer, MD, Ronald Hoffman, MD, Olatoyosi Odenike, MD , Laurie Sherman, BSN, Souria Dougherty, BS, MBA, Faye M. Feller, MD, Tymara Berry, MD, Libo Sun, PhD, Ying Wan, MD, PhD, Aleksandra Rizo, MD, Fei Huang, PhD, Jean-Jacques Kiladjian, MD, PhD
https://www.geron.com/file.cfm/53/docs/ ... _FINAL.pdf



Dr Srdan Verstovsek (USA): P3 IMpact (MF)
https://faculty.mdanderson.org/profiles ... ovsek.html
Specified Indications: MF, MDS, MPN
P3 Site Location: MD Anderson Cancer Center – Houston, TX
Geron Abstracts/Affiliations:
1 – (2013) IMETELSTAT: A NOVEL APPROACH WITH ROBUST HEMATOLOGIC AND MOLECULAR RESPONSES IN A PHASE 2 STUDY IN PATIENTS WITH ESSENTIAL THROMBOCYTHEMIA (ET) WHO ARE REFRACTORY OR INTOLERANT TO PRIOR THERAPY Gabriela M. Baerlocher, MD, Elisabeth Oppliger Leibundgut, Gary Spitzer, Oliver Ottmann, Olatoyosi Odenike, Alexander Röth, Michael McDevitt, Srdan Verstovsek, Kevin Nishimoto, Christina Ayran, Ted Shih, Xiaolin Wang, Dianne Morfeld, David Snyder
https://www.geron.com/file.cfm/53/docs/ ... A-2013.pdf

2 – (2020) Novel Concepts of Treatment for Patients with Myelofibrosis and Related Neoplasms
by Prithviraj Bose, Lucia Masarova and Srdan Verstovsek

https://www.mdpi.com/2072-6694/12/10/2891/htm



Dr Jun Ho Jang (South Korea): P3 IMerge (MDS)
https://www.samsunghospital.com/gb/lang ... ?dr_no=318
Specified Indications: MDS, AML, AA, PNH
P3 Site Location: Samsung Medical Center – Seoul, Korea
Geron Abstracts/Affiliations:
1 - (2021) Imetelstat Achieves Meaningful and Durable Transfusion Independence in High Transfusion-Burden Patients With Lower-Risk Myelodysplastic Syndromes in a Phase II Study
David P Steensma 1, Pierre Fenaux 2, Koen Van Eygen 3, Azra Raza 4, Valeria Santini 5, Ulrich Germing 6, Patricia Font 7, Maria Diez-Campelo 8, Sylvain Thepot 9, Edo Vellenga 10, Mrinal M Patnaik 11, Jun Ho Jang 12, Helen Varsos 13, Jacqueline Bussolari 13, Esther Rose 13, Laurie Sherman 14, Libo Sun 14, Ying Wan 14, Souria Dougherty 14, Fei Huang 14, Faye Feller 14, Aleksandra Rizo 14, Uwe Platzbecker 15

https://pubmed.ncbi.nlm.nih.gov/33108243/

2 – (2021) IMETELSTAT DEMONSTRATES AN ACCEPTABLE SAFETY PROFILE IN MYELOID MALIGNANCIES
John Mascerenhas, Valeria Santini, Jean-Jacques Kiladjian, Pierre Fenaux, Rami S. Komrokji, Koen Van Eygen, Francesca Palandri, Azra Raza, Bruno Martino, Ulrich Germing, Dietger Niederwieser, Patricia Font, Andreas Reiter, Maria Diez-Campelo, Bart L. Scott, Sylvain Thepot, Maria R. Baer, Edo Vellenga, Ronald Hoffman, Mrinal M. Patnaik, Olatoyosi Odenike, Jun Ho Jang, Alessandro Vannucchi, Laurie Sherman, Souria Dougherty, Fei Huang, Tymara Berry, Libo Sun, Ying Wan, Aleksandra Rizo, Faye M. Feller, Uwe Platzbecker

https://library.ehaweb.org/eha/2021/eha ... Amedia%3D1



Dr María Díez‐Campelo (Spain): P3 IMerge (MDS)
https://mds-europe.org/right/partners/iecscyl
Specified Indications: MDS
P3 Site Location: Hosp. Clinico Univ. de Salamanca – Salamanca, Spain
Geron Abstracts/Affiliations:
1 – (2021) On-Target Activity of Imetelstat Correlates with Clinical Benefits, Including Overall Survival (OS), in Heavily Transfused Non-Del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs)
Valeria Santini, Pierre Fenaux, Koen Van Eygen, Azra Raza, Ulrich Germing, Patricia Font, Maria Diez-Campelo, Sylvain Thepot, Edo Vellenga, Mrinal M. Patnaik, Jun Ho Jang, Laurie Sherman, Tymara Berry, Faye Feller, Souria Dougherty, Libo Sun, Ying Wan, Aleksandra Rizo, Fei Huang, Uwe Platzbecker
https://ashpublications.org/blood/artic ... lates-with

2 – (2018) Imetelstat Treatment Leads to Durable Transfusion Independence (TI) in RBC Transfusion-Dependent (TD), Non-Del(5q) Lower Risk MDS Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Who Are Lenalidomide (LEN) and HMA Naïve
David P. Steensma, Uwe Platzbecker, Koen Van Eygen, Azra Raza, MD, Valeria Santini, Ulrich Germing, MD, Patricia Font, MD, Irina Samarina, MD, Maria Díez-Campelo, Sylvain Thepot, MD, Edo Vellenga, Mrinal M. Patnaik, MDMBBS, Jun Ho Jang, MD PhD, Jacqueline Bussolari, PhD, Laurie Sherman, BSN, Libo Sun, PhD, Helen Varsos, MS, RPh, Esther Rose, MD, Pierre Fenaux

https://ashpublications.org/blood/artic ... ransfusion




Dr David Steensma (USA): Global Hematology Head · Novartis Institutes for BioMedical Research (NIBR) Cambridge, MA – P2 IMerge (MDS)
https://www.linkedin.com/in/david-steensma-12755620

Geron Abstracts/Affiliations:
1 – (2021) - Imetelstat Improves Rate of Durable Transfusion Independence in Patients With Lower-Risk MDS
David P. Steensma, MD; Pierre Fenaux, MD, PhD; Koen Van Eygen, MD; Azra Raza, MD; Valeria Santini, MD; Ulrich Germing, MD, PhD; Patricia Font, MD; Maria Diez-Campelo, MD, PhD; Sylvain Thepot, MD; Edo Vellenga, MD, PhD; Mrinal M. Patnaik, MBBS; Jun Ho Jang, MD; Helen Varsos, MS, RPh; Jacqueline Bussolari, PhD; Esther Rose, MD; Laurie Sherman, RN; Libo Sun, PhD; Ying Wan, MD, PhD; Souria Dougherty, BS, MBA; Fei Huang, PhD; Faye Feller, MD; Aleksandra Rizo, MD, PhD; and Uwe Platzbecker, MD

https://www.ashclinicalnews.org/news/li ... -risk-mds/

2 – (2020) - Geron Announces Publication of IMerge Phase 2 Data in Journal of Clinical Oncology
https://www.bloomberg.com/press-release ... l-oncology


***Let us remember the sacrifices of those patients currently undergoing treatment in the P3 Clinical Trial of Imetelstat. Without them, none of this would be possible. -Kmall

biopearl123
Posts: 1670
Joined: Fri Jul 20, 2018 5:13 pm

Re: Somebody Call Me A Doctor...........Champions Of Imetelstat

Post by biopearl123 » Sun Apr 03, 2022 3:45 pm

Kmall: somebody call me a doctor
bp: OK, you’re a doctor

In all seriousness, kmall, another great compilation
Thanks for all the great contributions you have made to this board and for acknowledging those patients who have sacrificed to participate in the studies that we hope will culminate in approval for all who need this drug.

kmall
Posts: 755
Joined: Thu Mar 21, 2019 3:57 pm

Re: Somebody Call Me A Doctor...........Champions Of Imetelstat

Post by kmall » Mon Apr 04, 2022 6:42 am

Andrew-bp - I think sometimes the patients involved in the Clinical Trials get somewhat overlooked in the process of Geron becoming a formidable presence in the Hematological Disorder space. Without their contributions nothing here is possible. Dr. Scarlett has mentioned them previously on several occasions. We should all reflect on the importance of their decisions in the advancement of Imetelstat globally. -Kmall

biopearl123
Posts: 1670
Joined: Fri Jul 20, 2018 5:13 pm

Re: Somebody Call Me A Doctor...........Champions Of Imetelstat

Post by biopearl123 » Mon Apr 04, 2022 7:43 am

Well said.

biopearl123
Posts: 1670
Joined: Fri Jul 20, 2018 5:13 pm

Re: Somebody Call Me A Doctor...........Champions Of Imetelstat

Post by biopearl123 » Mon Apr 04, 2022 4:14 pm

At least crossover is allowed in the QT study and the MF study from placebo to drug arms. I do wonder how the “gap” between PIII data release in the MDS study and actual approval will be handled as it seems there is no obvious mechanism to bring drug to patients during this interval. Will we finally see compassionate use approved to fill in?

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