The Board of Directors of MolMed S.p.A., chaired by Prof. Claudio Bordignon, today reviewed and approved the interim financial report at 30 September 2013. The most important elements were: TK: expansion in the US of the pivotal Phase III trial for high-risk leukaemia patients; NGR-TNF: continuation of the clinical development program; the increase of revenues to € 3.1 million from development of new cell and gene therapy treatments for third parties.
Milan (Italy), 11 November 2013 – The Board of Directors of MolMed S.p.A. (MLM.MI), chaired by Prof. Claudio Bordignon, today reviewed and approved the interim financial report at 30 September 2013. The most important elements were:
TK: expansion in the US of the pivotal Phase III trial (TK008) for high-risk leukaemia patients;
NGR-hTNF: continuation of the clinical development program, in particular with the achievement of new statistically significant results on the increase in overall survival of patients treated weekly with low doses NGR-hTNF in combination with doxorubicin in the randomised Phase II study in soft tissues sarcomas;
The increase of revenues to € 3.1 million (+11.9% compared to the first 9 months 2012) from development of new cell and gene therapy treatments for third parties.
Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: “Consistently with the first half of 2013, the last quarter was characterized by important confirmation on the potential of both our investigational antitumoral therapeutics: TK and NGR-hTNF. As far as TK is concerned, the expansion of the Phase III clinical study in the United States opens a new important frontier for the company, with an important sign of interest by prestigious American clinical centers participating in the study.
With regard to NGR- hTNF, the analysis of the randomized Phase II trial of NGR -hTNF in soft tissue sarcomas showed – in addition to what was already observed last year in terms of progression-free survival – a statistically significant increase in overall survival for those patients included in the arm treated with the 0.8 µg/sqm dose of NGR-hTNF administered weekly in combination with doxorubicin. These results confirm the previously observed effectiveness of NGR-hTNF in various cancer indications and validate the choice of the low doses administered weekly utilized in the treatment of malignant pleural mesothelioma currently in Phase III, with results expected between December 2013 and January 2014.
The activities in development and production of cell and gene therapies confirmed the leadership of the Company is playing at an international level is confirmed by the results obtained in this field and by the constant increase in revenues”.
Highlights of financial data
Key income statements
Key achievements in the first nine months of 2013
Research & Clinical Development activities
In the first nine months of 2013, the Company’s activities focused mainly on clinical development of its two investigational anticancer therapeutics: TK for the treatment of high-risk leukaemia and NGR-hTNF for the treatment of a number of solid tumours.
TK main achievements include:
expansion in the US of the pivotal Phase III trial (TK008) of its proprietary TK cell therapy for high-risk leukaemia patients. The study, already ongoing in Europe, foresees patient enrolment in 16 clinical centres in Europe, United States and Israel;
presentation at ASCO 2013 and at the BMT Tandem Meetings 2013 of positive long-term safety and efficacy data with its cell therapy product TK for the treatment of hematologic malignancies with bone marrow transplantation from partially matched (haplo-identical) donors. The seven year follow-up analysis of this large patient population indicates that overall and disease-free survivals from haploidentical family donors are fully comparable to those obtained from fully matched donors;
progress on dossier preparation in order to file for a market authorisation application for TK through a special procedure (Conditional Marketing Authorisation) with the European Medicines Agency. This request is based on the rarity of the indication (TK has obtained Orphan Drug designation), the favourable risk/benefit ratio and the demonstration of safety and clinical efficacy obtained in more than 120 patients treated so far. The Company expects to file this request with the European authority in 2013.
NGR-hTNF main achievements include:
presentation at the European Cancer Congress 2013 (ECCO-ESMO-ESTRO) of new data showing a statistically significant doubling of the median survival – associated with a favourable tolerability profile – of patients treated weekly with low doses NGR-hTNF in combination with doxorubicin in the randomised Phase II study in soft tissues sarcomas;
completion of patient enrolment in a randomised Phase II trial in platinum-resistant/refractory ovarian cancer patients. Results of the study are expected in the first half of 2014;
presentation at ASCO of positive results from a randomized Phase II study evaluating safety and efficacy of its investigational drug NGR-hTNF in combination with standard chemotherapy for the first-line therapy of non-small cell lung cancer (NSCLC) patients with squamous histology. The addition of NGR-hTNF to standard chemotherapy induced a two-fold higher tumour shrinkage and, most importantly, a statistically significant 50% reduction in the risk of death compared to chemotherapy alone (p=0.04). Notably, these efficacy outcomes were coupled with a favourable tolerability profile.
Milan (Italy), 11 November 2013 – The Board of Directors of MolMed S.p.A. (MLM.MI), chaired by Prof. Claudio Bordignon, today reviewed and approved the interim financial report at 30 September 2013. The most important elements were:
TK: expansion in the US of the pivotal Phase III trial (TK008) for high-risk leukaemia patients;
NGR-hTNF: continuation of the clinical development program, in particular with the achievement of new statistically significant results on the increase in overall survival of patients treated weekly with low doses NGR-hTNF in combination with doxorubicin in the randomised Phase II study in soft tissues sarcomas;
The increase of revenues to € 3.1 million (+11.9% compared to the first 9 months 2012) from development of new cell and gene therapy treatments for third parties.
Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: “Consistently with the first half of 2013, the last quarter was characterized by important confirmation on the potential of both our investigational antitumoral therapeutics: TK and NGR-hTNF. As far as TK is concerned, the expansion of the Phase III clinical study in the United States opens a new important frontier for the company, with an important sign of interest by prestigious American clinical centers participating in the study.
With regard to NGR- hTNF, the analysis of the randomized Phase II trial of NGR -hTNF in soft tissue sarcomas showed – in addition to what was already observed last year in terms of progression-free survival – a statistically significant increase in overall survival for those patients included in the arm treated with the 0.8 µg/sqm dose of NGR-hTNF administered weekly in combination with doxorubicin. These results confirm the previously observed effectiveness of NGR-hTNF in various cancer indications and validate the choice of the low doses administered weekly utilized in the treatment of malignant pleural mesothelioma currently in Phase III, with results expected between December 2013 and January 2014.
The activities in development and production of cell and gene therapies confirmed the leadership of the Company is playing at an international level is confirmed by the results obtained in this field and by the constant increase in revenues”.
Highlights of financial data
Key income statements
Key achievements in the first nine months of 2013
Research & Clinical Development activities
In the first nine months of 2013, the Company’s activities focused mainly on clinical development of its two investigational anticancer therapeutics: TK for the treatment of high-risk leukaemia and NGR-hTNF for the treatment of a number of solid tumours.
TK main achievements include:
expansion in the US of the pivotal Phase III trial (TK008) of its proprietary TK cell therapy for high-risk leukaemia patients. The study, already ongoing in Europe, foresees patient enrolment in 16 clinical centres in Europe, United States and Israel;
presentation at ASCO 2013 and at the BMT Tandem Meetings 2013 of positive long-term safety and efficacy data with its cell therapy product TK for the treatment of hematologic malignancies with bone marrow transplantation from partially matched (haplo-identical) donors. The seven year follow-up analysis of this large patient population indicates that overall and disease-free survivals from haploidentical family donors are fully comparable to those obtained from fully matched donors;
progress on dossier preparation in order to file for a market authorisation application for TK through a special procedure (Conditional Marketing Authorisation) with the European Medicines Agency. This request is based on the rarity of the indication (TK has obtained Orphan Drug designation), the favourable risk/benefit ratio and the demonstration of safety and clinical efficacy obtained in more than 120 patients treated so far. The Company expects to file this request with the European authority in 2013.
NGR-hTNF main achievements include:
presentation at the European Cancer Congress 2013 (ECCO-ESMO-ESTRO) of new data showing a statistically significant doubling of the median survival – associated with a favourable tolerability profile – of patients treated weekly with low doses NGR-hTNF in combination with doxorubicin in the randomised Phase II study in soft tissues sarcomas;
completion of patient enrolment in a randomised Phase II trial in platinum-resistant/refractory ovarian cancer patients. Results of the study are expected in the first half of 2014;
presentation at ASCO of positive results from a randomized Phase II study evaluating safety and efficacy of its investigational drug NGR-hTNF in combination with standard chemotherapy for the first-line therapy of non-small cell lung cancer (NSCLC) patients with squamous histology. The addition of NGR-hTNF to standard chemotherapy induced a two-fold higher tumour shrinkage and, most importantly, a statistically significant 50% reduction in the risk of death compared to chemotherapy alone (p=0.04). Notably, these efficacy outcomes were coupled with a favourable tolerability profile.