Molecular Medicine (MLM) Molmed (6 lettori)
- Creatore Discussione mb1
- Data di Inizio
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LGG
legio XII Fulminata
slitta il c.a. in Europa di 3 mesi, in compenso ci sarà b.t. in USA subito con risposta entro 60 giorni quindi per fine Gennaio/primi Febbraio, ed il manovratore può continuare a fare il bello ed il cattivo tempo......non ci sono parole, anzi si.......via da sta borsa di peracottari
LGG
legio XII Fulminata
Molecular Medicine SpA : Update on the registration strategy for the gene therapy TK in Europe and in the United States | 4-Traders
Molecular Medicine SpA : Update on the registration strategy for the gene therapy TK in Europe and in the United States
11/21/2013 | 02:16am US/Eastern
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PRESS RELEASE
MolMed provides an update on the registration strategy for its gene therapy TK in Europe and in the United States
Milan (Italy), 21 November 2013 - MolMed S.p.A. (Milan:MLM) provided today an update on the registration strategy it intends to implement for its gene therapy TK in Europe and in the US. This coming Monday, 25
November, the Company will meet in London the European Medicine Agency (EMA) authorities in a pre- submission meeting to discuss the European registration plan in order to finalize the application for the conditional approval. Based on the available timelines the company now expects to submit the final application for the conditional approval in the first quarter of next year.
Next week the Company will also expand its registration strategy for the gene therapy TK with the submission to the US Food and Drug Administration (FDA) of a request for Breakthrough Therapy designation. The decision to submit the request to access this regulatory process follows the recently announced start in the United States of patient's recruitment in the Phase III clinical trial (TK008). The FDA answer on the granting of the designation is expected within 60 days from the application submission.
About Breakthrough Therapy
Breakthrough therapy designation is a new regulatory option available at FDA and is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A breakthrough therapy designation conveys all of the fast track program features as well as more intensive FDA guidance on an efficient drug development program. Details of these regulatory processes can be found at this link:
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantA
mendmentstotheFDCAct/FDASIA/ucm341027.htm
About TK
TK is a cell therapy product, based on the use of genetically engineered donor T cells carrying a "suicide gene". These cells are administered to patients during the haematopoietic stem cell transplantation for the treatment of high risk leukaemia. TK therapy allows to eliminate the post-transplant immunosuppression treatment thus accelerating the immune reconstitution and controlling the immunological consequences arising from the genetic differences with the donor, known as Graft versus Host Disease (GvHD).
About Phase III trial TK008
TK008 is a pivotal randomised Phase III trial in adult patients affected by high-risk leukaemia undergoing transplant of haematopoietic stem cells collected from partially compatible (haploidentical) family donors. The trial design has disease-free survival as the primary end-point - which includes both transplant-related mortality and disease relapse - evaluated on a patient population of 170 patients. The trial will compare the outcome of haplo-transplants with or without TK add-backs, with a 3:1 randomisation ratio in favour of the TK arm. Secondary end-points include overall survival, reduction of transplant-related mortality, safety and
patients' quality of life.
FROM GENES TO THERAPY
MOLMED S.p.A.
Via Olgettina, 58 - 20132 Milan, Italy | Phone +39 02 21277.1 - Fax +39 02 21277.325 info @ molmed.com - www.molmed.com
Share capital € 27,070,992.30 fully paid - Office of Milan Company Registry number 1506630 - Tax identification number 11887610159
1
PRESS RELEASE
With the aim to provide additional clinical benefit to patients and to significantly increase the pote ntial participation of centres in the trial, the Company implemented in 2012 two important changes in the protocol design of Phase III trial TK008. The first consists in broadening the enrolment criteria to include patients in leukaemic relapse, in addition to those in disease remission; the second change provides for the introduction of a further treatment option in the control arm, based on the use of an unmanipulated transplant followed by cyclophosphamide administration during the post-transplantation period.
This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14 May 1999, as subsequently amended.
About MolMed
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed's pipeline includes two antitumour therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent, in Phase III in malignant pleural mesothelioma and in Phase II in six more indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The Company's shares are listed on the main market (MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI)
For further information:
Marina Del Bue
General Manager Business & Administration
MolMed S.p.A.
phone: +39 02 21277.371 fax: +39 02 21277.325
e-mail: investor.relations @ molmed.com
DISCLAIMER
This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of MolMed S.p.A.
FROM GENES TO THERAPY
2
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Molecular Medicine SpA : Update on the registration strategy for the gene therapy TK in Europe and in the United States
11/21/2013 | 02:16am US/Eastern
0
PRESS RELEASE
MolMed provides an update on the registration strategy for its gene therapy TK in Europe and in the United States
Milan (Italy), 21 November 2013 - MolMed S.p.A. (Milan:MLM) provided today an update on the registration strategy it intends to implement for its gene therapy TK in Europe and in the US. This coming Monday, 25
November, the Company will meet in London the European Medicine Agency (EMA) authorities in a pre- submission meeting to discuss the European registration plan in order to finalize the application for the conditional approval. Based on the available timelines the company now expects to submit the final application for the conditional approval in the first quarter of next year.
Next week the Company will also expand its registration strategy for the gene therapy TK with the submission to the US Food and Drug Administration (FDA) of a request for Breakthrough Therapy designation. The decision to submit the request to access this regulatory process follows the recently announced start in the United States of patient's recruitment in the Phase III clinical trial (TK008). The FDA answer on the granting of the designation is expected within 60 days from the application submission.
About Breakthrough Therapy
Breakthrough therapy designation is a new regulatory option available at FDA and is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A breakthrough therapy designation conveys all of the fast track program features as well as more intensive FDA guidance on an efficient drug development program. Details of these regulatory processes can be found at this link:
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantA
mendmentstotheFDCAct/FDASIA/ucm341027.htm
About TK
TK is a cell therapy product, based on the use of genetically engineered donor T cells carrying a "suicide gene". These cells are administered to patients during the haematopoietic stem cell transplantation for the treatment of high risk leukaemia. TK therapy allows to eliminate the post-transplant immunosuppression treatment thus accelerating the immune reconstitution and controlling the immunological consequences arising from the genetic differences with the donor, known as Graft versus Host Disease (GvHD).
About Phase III trial TK008
TK008 is a pivotal randomised Phase III trial in adult patients affected by high-risk leukaemia undergoing transplant of haematopoietic stem cells collected from partially compatible (haploidentical) family donors. The trial design has disease-free survival as the primary end-point - which includes both transplant-related mortality and disease relapse - evaluated on a patient population of 170 patients. The trial will compare the outcome of haplo-transplants with or without TK add-backs, with a 3:1 randomisation ratio in favour of the TK arm. Secondary end-points include overall survival, reduction of transplant-related mortality, safety and
patients' quality of life.
FROM GENES TO THERAPY
MOLMED S.p.A.
Via Olgettina, 58 - 20132 Milan, Italy | Phone +39 02 21277.1 - Fax +39 02 21277.325 info @ molmed.com - www.molmed.com
Share capital € 27,070,992.30 fully paid - Office of Milan Company Registry number 1506630 - Tax identification number 11887610159
1
PRESS RELEASE
With the aim to provide additional clinical benefit to patients and to significantly increase the pote ntial participation of centres in the trial, the Company implemented in 2012 two important changes in the protocol design of Phase III trial TK008. The first consists in broadening the enrolment criteria to include patients in leukaemic relapse, in addition to those in disease remission; the second change provides for the introduction of a further treatment option in the control arm, based on the use of an unmanipulated transplant followed by cyclophosphamide administration during the post-transplantation period.
This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14 May 1999, as subsequently amended.
About MolMed
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed's pipeline includes two antitumour therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent, in Phase III in malignant pleural mesothelioma and in Phase II in six more indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The Company's shares are listed on the main market (MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI)
For further information:
Marina Del Bue
General Manager Business & Administration
MolMed S.p.A.
phone: +39 02 21277.371 fax: +39 02 21277.325
e-mail: investor.relations @ molmed.com
DISCLAIMER
This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of MolMed S.p.A.
FROM GENES TO THERAPY
2
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LGG
legio XII Fulminata
ozzioporcone a momenti svengo
http://www.molmed.com/sites/default...d_per_uso_compassionevole/2346_1385064300.pdf
http://www.molmed.com/sites/default...d_per_uso_compassionevole/2346_1385064300.pdf
LGG
legio XII Fulminata
Claudio Bordignon, Presidente ed Amministratore Delegato di MolMed, commenta: "Questo nuovo accordo con GSK da una parte conferma l'eccellenza tecnico-scientifica e industriale di MolMed, che vede rafforzata la propria leadership nel campo delle terapie geniche e cellulari, e, dall'altra, dimostra la nostra capacità di costruire e rafforzare una partnership commerciale con un importante gruppo farmaceutico mondiale." In base all'accordo precedente – annunciato da MolMed in agosto 2011 – MolMed ha sviluppato il processo produttivo per la terapia genica sperimentale ADA-SCID.
Bene questo commento di Bordignon mi pare un chiaro messaggio a qualcuno, io un'idea di quello che sta accadendo me la sono fatta, ma non voglio condizionare nessuno....ognuno lo interpreti come vuole, ma il messaggio c'è, ed è palese.
Bene questo commento di Bordignon mi pare un chiaro messaggio a qualcuno, io un'idea di quello che sta accadendo me la sono fatta, ma non voglio condizionare nessuno....ognuno lo interpreti come vuole, ma il messaggio c'è, ed è palese.
sepp maier
IMPARO DA TUTTI
stamattina vedo per la prima volta il MM fare fatica ad arginare i corsi. Cerca di farlo senza dare nell'occhio ma non gli riesce bene come al solito e considerando che non ci sono volumi...
LGG
legio XII Fulminata
nico37
MLM, BF, MI, FKR, FSAR
io le ho riconsegnate tutte, non mi rischio i risultati ngr, riconsidero tutto dopo i dati.
Se per caso nel frattempo arrivasse l'accordo le bestemmione le senti fino a Parma
Ciao seppiolone
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