Belinostat PTCL trial fully enrolled
Copenhagen, Denmark - 26 September 2011 - Today Topotarget A/S (NASDAQ OMX: TOPO.CO) announced that Topotarget and Spectrum Pharmaceuticals achieve target enrollment for the pivotal PTCL trial for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).
Registrational trial under a Special Protocol Assessment by FDA
Granted Fast Track and Orphan Drug Designation by FDA
On track to file New Drug Application in 2012
Topotarget and Spectrum Pharmaceuticals have now completed the enrollment of a minimum of 100 evaluable relapsed or refractory peripheral T-cell lymphoma (PTCL) patients in the PTCL registration trial. Belinostat, a novel HDAC inhibitor, is being evaluated, under a Special Protocol Assessment (SPA), as monotherapy treatment for relapsed or refractory PTCL, an indication for which it has been granted Orphan Drug and Fast Track Designation by the U.S. Food and Drug Administration (FDA). Central review of pathology for all patients entered into the trial is currently ongoing.
“It is of major importance to us that we successfully achieved this key milestone by completing the enrollment of the pivotal BELIEF trial for the treatment of relapsed or refractory PTCL” says Francois Martelet, MD, CEO of Topotarget. “We are delighted that our lead project is on track for filing in the US”.
“We are pleased to announce that belinostat’s pivotal, registrational trial in relapsed/refractory PTCL has achieved its target enrollment,” says Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Belinostat is a novel HDAC inhibitor that has the potential to play an important role in therapy for PTCL, an often lethal disease with significant unmet medical need, and in a variety of other indications. It has shown to be active as a single agent and in combination with other chemotherapeutic agents in multiple clinical trials. We plan to file a New Drug Application in 2012. If approved, we believe belinostat will add Value to our existing hematology/oncology portfolio, increase our current sales efforts in hematology/oncology, and demonstrate our commitment to developing novel treatments for lymphoma.”
According to the Lymphoma Research Foundation (www.lymphoma.org), lymphoma is the most common blood cancer. The two main forms of lymphoma are Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL). Lymphoma occurs when lymphocytes, a type of white blood cell, grow abnormally where they reside in the lymph glands. The body has two main types of lymphocytes that can develop into lymphomas: B-lymphocytes (B-cells) and T-lymphocytes (T-cells). PTCL comprises a group of rare and aggressive NHLs that develop from mature T-cells. PTCL accounts for approximately 10 to 15% of all NHL cases in the US.
About the BELIEF Registrational trial
Belinostat is currently in a registrational, pivotal trial, under a SPA, as monotherapy for relapsed and refractory PTCL, an indication which has been granted Orphan Drug and Fast Track Designation by the FDA. The registrational trial is an open-label, multicenter, single arm efficacy and safety trial in patients with relapsed or refractory PTCL, who have failed at least one prior systemic therapy. The primary endpoint is centrally reviewed objective overall response rate (ORR).
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Copenhagen, Denmark - 26 September 2011 - Today Topotarget A/S (NASDAQ OMX: TOPO.CO) announced that Topotarget and Spectrum Pharmaceuticals achieve target enrollment for the pivotal PTCL trial for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL).
Registrational trial under a Special Protocol Assessment by FDA
Granted Fast Track and Orphan Drug Designation by FDA
On track to file New Drug Application in 2012
Topotarget and Spectrum Pharmaceuticals have now completed the enrollment of a minimum of 100 evaluable relapsed or refractory peripheral T-cell lymphoma (PTCL) patients in the PTCL registration trial. Belinostat, a novel HDAC inhibitor, is being evaluated, under a Special Protocol Assessment (SPA), as monotherapy treatment for relapsed or refractory PTCL, an indication for which it has been granted Orphan Drug and Fast Track Designation by the U.S. Food and Drug Administration (FDA). Central review of pathology for all patients entered into the trial is currently ongoing.
“It is of major importance to us that we successfully achieved this key milestone by completing the enrollment of the pivotal BELIEF trial for the treatment of relapsed or refractory PTCL” says Francois Martelet, MD, CEO of Topotarget. “We are delighted that our lead project is on track for filing in the US”.
“We are pleased to announce that belinostat’s pivotal, registrational trial in relapsed/refractory PTCL has achieved its target enrollment,” says Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Belinostat is a novel HDAC inhibitor that has the potential to play an important role in therapy for PTCL, an often lethal disease with significant unmet medical need, and in a variety of other indications. It has shown to be active as a single agent and in combination with other chemotherapeutic agents in multiple clinical trials. We plan to file a New Drug Application in 2012. If approved, we believe belinostat will add Value to our existing hematology/oncology portfolio, increase our current sales efforts in hematology/oncology, and demonstrate our commitment to developing novel treatments for lymphoma.”
According to the Lymphoma Research Foundation (www.lymphoma.org), lymphoma is the most common blood cancer. The two main forms of lymphoma are Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL). Lymphoma occurs when lymphocytes, a type of white blood cell, grow abnormally where they reside in the lymph glands. The body has two main types of lymphocytes that can develop into lymphomas: B-lymphocytes (B-cells) and T-lymphocytes (T-cells). PTCL comprises a group of rare and aggressive NHLs that develop from mature T-cells. PTCL accounts for approximately 10 to 15% of all NHL cases in the US.
About the BELIEF Registrational trial
Belinostat is currently in a registrational, pivotal trial, under a SPA, as monotherapy for relapsed and refractory PTCL, an indication which has been granted Orphan Drug and Fast Track Designation by the FDA. The registrational trial is an open-label, multicenter, single arm efficacy and safety trial in patients with relapsed or refractory PTCL, who have failed at least one prior systemic therapy. The primary endpoint is centrally reviewed objective overall response rate (ORR).
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26/9 2011 15:04 jenshjensh 0
46707 Dermed er der nu en rimeligt kendt deadline i forhold til afklaring af potentialet i forhold til PTCL. Dette studie havde efterhånden fået status af uendelighed ..... dejligt at rekrutteringen nu endeligt er på plads.
Hvorvidt der er grundlag for faseIII i CUP er også i mine øjne meget interessant, i forhold til tid ved vi vel reelt kun - at vi har fået oplyst H2.
vh Jensh
Hvorvidt der er grundlag for faseIII i CUP er også i mine øjne meget interessant, i forhold til tid ved vi vel reelt kun - at vi har fået oplyst H2.
vh Jensh
26/9 2011 15:13 Gorm 046708 Ja, men vi har ju också ett yttrande av ansvarigt läkarlag till en av de medverkande klinikerna från december, d.v..s. just efter rekryteringens avslutning, då man skriver:
"We remain excited about belinostat and look forward to sharing study results in 2011"
"We remain excited about belinostat and look forward to sharing study results in 2011"
"We remain excited about belinostat and look forward to sharing study results in 2011"
"We remain excited about belinostat and look forward to sharing study results in 2011"
26/9 2011 15:55 HSK 046713 Jens - hvad er din fornemmelse for tidsrammen fra nu af ?
Kunne forstå på TOPO at selv om der bliver lavet "rolling submission" af SPPI vil der først blive taget stilling til om FDA vil behandle sagen, når de sidste data er indsendt.
Man må da håbe at de begynder at kigge på data efterhånden som de løber ind, for ellers giver det da ingen mening at indsende dem løbende...
Mvh
HSK
Kunne forstå på TOPO at selv om der bliver lavet "rolling submission" af SPPI vil der først blive taget stilling til om FDA vil behandle sagen, når de sidste data er indsendt.
Man må da håbe at de begynder at kigge på data efterhånden som de løber ind, for ellers giver det da ingen mening at indsende dem løbende...
Mvh
HSK
27/9 2011 15:23 jenshjensh 046745 Hej HSK.
Den sidste patient er jo nu rekrutteret - så skal der behandles, og efterfølgende skal effekten af behandlingen undersøges. Så efter min bedste overbevisning, så kommer vi til at få andre nyheder fra TOPO, før vi vender tilbage til resultat af PTCL. Nærmere et "tidsforløb" får du ikke af mig.
vh Jensh
Den sidste patient er jo nu rekrutteret - så skal der behandles, og efterfølgende skal effekten af behandlingen undersøges. Så efter min bedste overbevisning, så kommer vi til at få andre nyheder fra TOPO, før vi vender tilbage til resultat af PTCL. Nærmere et "tidsforløb" får du ikke af mig.
vh Jensh
