Information
Generic Name: TK cell therapy
Trade Name: Zalmoxis
Synonym: HSV-Tk; TBI-0301; Thymidine kinase cell therapy
Entry Type: Cell-based therapy
Developmental Status
UK: Pre-registration (Filed)
EU: Pre-registration (Filed)
US: Phase III Clinical Trials
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Apr 14: The application to the FDA for TK cell therapy for adjunctive treatment in HSCT for adult pts with high-risk acute leukaemia had been refused. The FDA suggested that the application can be resubmitted when new clinical evidence is available. [7]
02/04/2014 12:47:02
TK therapy was granted Orphan Drug Designation (EU/3/10/773) in the EU in Sep 10 [6]
14/03/2014 18:59:00
Mar 14: An application for Conditional Marketing Authorisation for TK has been filed in the EU as an adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for patients affected by high risk leukaemia. The application is supported by efficacy and safety results obtained from a completed PI/II multicentre trial (TK007) and supported by initial data from the ongoing randomised PIII study (TK008) [5].
14/03/2014 18:53:39
Mar 13: MolMed reports it has begun preparing its regulatory dossier to support Conditional Marketing Approval in the EU, based on safety & efficacy data obtained from more than 120 patients in its ongoing PIII trial. The company expects to submit its request for approval of TK cell therapy to treat leukaemia to the EMA by mid-2013 [2].
13/05/2013 11:32:49
Trial or other data
Under a licence agreement with Oxford BioMedica, MolMed´s TK therapy product employs Oxford BioMedica´s retroviral ex vivo gene delivery technology [2].
13/05/2013 11:49:04
Apr 13: The company announces it is expanding production capacity to support the ongoing PIII trial & future commercialisation of the TK cell therapy product [2].
13/05/2013 11:48:56
Feb 13: Positive results reported following analysis of data from 611 pts in Italy over eight years, including pts from the PII TK007 (NCT00423124) & PIII TK008 (NCT00914628) trials. The results indicated that overall & disease-free survival was comparable between pts who had received fully matched or partially match bone marrow transplants [2].
13/05/2013 11:47:26
Aug 12: MolMed announces that, in order to increase the recruitment rate in its PIII trial of TK cell therapy, it would start enrolling patients with more advanced disease. The trial is comparing TK cell therapy with a standard T cell repletion strategy, in reducing non-relapse mortality following (haplo-HSCT in pts with acute high-risk leukaemia (TK 008; NCT00914628; EudraCT 2009-012973-37). The trial is intended to enrol 170 pts and is recruiting in the US, Italy, Belgium, France, Germany, Greece, the Netherlands & Spain. MolMed received clearance from the US FDA to expand recruitment in the trial to sites in the US, following submission of an IND in Nov 2010. Primary analysis of results is expected in 2013 [2].
13/05/2013 11:42:46
Jun 10: Positive results from a PII study (NCT00423124) reported at ASCO-2010. The trial enrolled 57 pts in Germany, Greece, Israel, Italy, & the UK. The trial involved haplo-SCT, followed by the TK cell therapy for patients with high risk haematological malignancies (including ALL & AML) [2].
13/05/2013 11:41:30
TK cell therapy is administered once at 21 days after HSCT, and then up to three times subsequently [1].
13/05/2013 11:34:42
TK-based cell therapy (herpes simplex virus thymidine kinase donor lymphocytes; HSV-TK) is an immunostimulant product based on T cells from a donor, potentially enabling safer HSCT from haploidentical donors. TK cell therapy consists of donor T cells genetically engineered ex vivo to express HSV-TK, making these cells sensitive to the antiviral drug ganciclovir. This modification reduces the risk of Graft versus Host Disease (GvHD) and preserves the protection against infection and disease relapse provided by donor T cells. In addition, there is no need for post-transplant immuno-suppression. TK cell therapy may therefore increase the effectiveness of HSCT in pts who do not have a fully compatible donor [1].
13/05/2013 11:34:10
Evidence Based eva luations
NHSC/NIHR http://www.hsc.nihr.ac.uk/files/downloads/2027/2366.05105aff.TKcelltherapy_Mar13.pdf
References
Available only to registered users
Category
BNF Category: Other immunomodulating drugs (08.02.04)
Pharmacology: A thymidine kinase (TK)-based cell therapy involving genetically engineered haplo-identical (allogenic) T lymphocytes in pts undergoing SCT with partially compatible family donors, known as haplo-identical Haematopoietic Stem Cell Transplantation.
Epidemiology: The incidence of AML is 3.7 per 100,000 people; the incidence of CLL is 1 per 100,00 people [4].
Indication: Acute lymphoblastic leukaemia (ALL)
Additional Details: & AML - in pts having HSCT but without a matched donor
Method(s) of Administration
Intravenous infusion
Company Information
Name: MolMed
US Name: MolMed
NICE Information
In timetable: No
|
