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MolMed - At ASCO 2015 survival data in poor
prognosis patients achieved in the Phase III trial on
NGR-hTNF treatment in pleural mesothelioma
Oral presentation at ASCO 2015 of survival data in poor prognosis patients achieved in the
Phase III trial on NGR-hTNF treatment in pleural mesothelioma
Milan (Italy), 1 June 2015 – MolMed S.p.A. (MLM.MI) announces that the complete results
of the Phase III trial with its investigational therapeutic NGR-hTNF in mesothelioma were
presented and discussed orally in the “Lung Cancer-NSCLC local-regional/SCLC/Other Tho-
racic Cancers” session at the 51st ASCO Annual Meeting underway in Chicago (IL, USA)
from May 29th to June 2nd.
The international phase III trial, which started in 2010 and whose top line results were re-
leased in 2014, showed a statistically significant 45% improvement in overall survival in
patients who progressed more rapidly after first-line treatment. This outcome was ob-
served in the 50% of patients with a poorer prognosis, while the primary endpoint was not
met for the entire population.
In this poor prognosis patient population, the robustness of the benefit induced by NGR-
hTNF in combination with chemotherapy, over chemotherapy alone, has been confirmed
by the efficacy consistently reported across all patient subgroups, defined on the basis of
well-established risk factors (e.g. histology, performance status, age, sex, etc.), and across
all the other study endpoints, with NGR-hTNF able to prolong progressionfree survival time
by 45%, to reduce early progression rate by 45% and to increase the survival duration in
patients with disease control by 65%.
The meaningfulness of results achieved in mesothelioma patients has been further en-
dorsed by additional analyses related to the phase III trial data that were also presented
at the ASCO conference in two poster presentations.
The first analysis highlighted the value of the clinical parameter - the treatment-free inter-
val after first-line therapy - in easily identifying patients who benefited most from NGR-hT-
NF treatment and in defining the increased aggressiveness and poor prognosis of disease.
The second analysis indicated the rationale underlying the increased NGR-hTNF effects ob-
served in the patient population presenting with disease characterized by an augmented
tumor angiogenesis (as assessed by high circulating lactate dehydrogenase levels), and
the key role of patient immune status in predicting NGR-hTNF efficacy. Indeed, in those
patients who presented with elevated blood markers of angiogenesis and of the immune
response, overall survival improved by 72% and progression-free survival by 89% with
NGR-hTNF plus chemotherapy compared with chemotherapy alone.
These clinical results are also in line with the drug’s hypothesized mechanism of action,
which is based on an improved intratumoral penetration of chemotherapeutic agents and
increased tumor lymphocyte infiltration, thanks to NGR-hTNF’s activity on newly formed
tumor vasculature.
MolMed’s global effort in the treatment of mesothelioma is further reinforced by the cur-
rently ongoing randomized Phase II trial with NGR-hTNF given as a maintenance approach
after completion of first-line therapy.
Claudio Bordignon, Chairman and CEO of MolMed, commented: “The oral presentation of
the data PRESS RELEASE FROM GENES TO THERAPY 2 discussed at the ASCO meeting ac-
knowledges the value of the results achieved by NGR-hTNF in those patients who suffer
from a resistant disease and are most in need of treatment options, and significantly con-
firms the therapeutic potential of the molecule already observed in other tumor indications
evaluated in Phase II trials. The identification of patients who benefit most from NGR-hT-
NF, their extended survival time, and the consistently reported efficacy represent three key
results of the study and, more importantly, offer the perspective of a relevant and appro-
priate treatment choice for patients with poorer prognosis”.
These results represent the basis for the Company to pursue the next steps, including initi-
ation of the registration process, and the further clinical development of NGR-hTNF.
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 thera-
peutics in clinical development: TK, a cell-based therapy enabling bone marrow trans-
plants from partially compatible donors, in absence of post-transplant immune-suppres-
sion, 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 indica-
tions: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tis-
sue 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, includ-
ing scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of pa-
tient-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 mar-
ket (MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI)
FONTE: MolMed.com

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MolMed NGR-hTNF ASCO 2015, oral presentation of survival data

  • 1. MolMed - At ASCO 2015 survival data in poor prognosis patients achieved in the Phase III trial on NGR-hTNF treatment in pleural mesothelioma Oral presentation at ASCO 2015 of survival data in poor prognosis patients achieved in the Phase III trial on NGR-hTNF treatment in pleural mesothelioma Milan (Italy), 1 June 2015 – MolMed S.p.A. (MLM.MI) announces that the complete results of the Phase III trial with its investigational therapeutic NGR-hTNF in mesothelioma were presented and discussed orally in the “Lung Cancer-NSCLC local-regional/SCLC/Other Tho- racic Cancers” session at the 51st ASCO Annual Meeting underway in Chicago (IL, USA) from May 29th to June 2nd. The international phase III trial, which started in 2010 and whose top line results were re- leased in 2014, showed a statistically significant 45% improvement in overall survival in patients who progressed more rapidly after first-line treatment. This outcome was ob- served in the 50% of patients with a poorer prognosis, while the primary endpoint was not met for the entire population. In this poor prognosis patient population, the robustness of the benefit induced by NGR- hTNF in combination with chemotherapy, over chemotherapy alone, has been confirmed by the efficacy consistently reported across all patient subgroups, defined on the basis of well-established risk factors (e.g. histology, performance status, age, sex, etc.), and across all the other study endpoints, with NGR-hTNF able to prolong progressionfree survival time by 45%, to reduce early progression rate by 45% and to increase the survival duration in patients with disease control by 65%. The meaningfulness of results achieved in mesothelioma patients has been further en- dorsed by additional analyses related to the phase III trial data that were also presented at the ASCO conference in two poster presentations. The first analysis highlighted the value of the clinical parameter - the treatment-free inter- val after first-line therapy - in easily identifying patients who benefited most from NGR-hT- NF treatment and in defining the increased aggressiveness and poor prognosis of disease. The second analysis indicated the rationale underlying the increased NGR-hTNF effects ob- served in the patient population presenting with disease characterized by an augmented tumor angiogenesis (as assessed by high circulating lactate dehydrogenase levels), and the key role of patient immune status in predicting NGR-hTNF efficacy. Indeed, in those patients who presented with elevated blood markers of angiogenesis and of the immune
  • 2. response, overall survival improved by 72% and progression-free survival by 89% with NGR-hTNF plus chemotherapy compared with chemotherapy alone. These clinical results are also in line with the drug’s hypothesized mechanism of action, which is based on an improved intratumoral penetration of chemotherapeutic agents and increased tumor lymphocyte infiltration, thanks to NGR-hTNF’s activity on newly formed tumor vasculature. MolMed’s global effort in the treatment of mesothelioma is further reinforced by the cur- rently ongoing randomized Phase II trial with NGR-hTNF given as a maintenance approach after completion of first-line therapy. Claudio Bordignon, Chairman and CEO of MolMed, commented: “The oral presentation of the data PRESS RELEASE FROM GENES TO THERAPY 2 discussed at the ASCO meeting ac- knowledges the value of the results achieved by NGR-hTNF in those patients who suffer from a resistant disease and are most in need of treatment options, and significantly con- firms the therapeutic potential of the molecule already observed in other tumor indications evaluated in Phase II trials. The identification of patients who benefit most from NGR-hT- NF, their extended survival time, and the consistently reported efficacy represent three key results of the study and, more importantly, offer the perspective of a relevant and appro- priate treatment choice for patients with poorer prognosis”. These results represent the basis for the Company to pursue the next steps, including initi- ation of the registration process, and the further clinical development of NGR-hTNF. 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.
  • 3. 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 thera- peutics in clinical development: TK, a cell-based therapy enabling bone marrow trans- plants from partially compatible donors, in absence of post-transplant immune-suppres- sion, 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 indica- tions: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tis- sue 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, includ- ing scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of pa- tient-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 mar- ket (MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI) FONTE: MolMed.com