New data presented at ASCO on NGR-hTNF show

significantly extended survival in very poor-

prognosis esothelioa and sarcoa patient
populations
A statistically significant 40% improvement of both overall survival and progression-free
survival in a large population of patients, identified by a pre-specified analysis on the prior
treatment-free interval, and who presented a very dismal prognosis was reported by
MolMed S.p.A. M!M.M"# this wee$end, at the %0
th
AS&' annual meeting.
(hese efficacy results were observed in an international randomi)ed *hase """ study evalu-
ating the investigational drug +,--h(+. in combination with best investigator choice in
400 patients with malignant pleural mesothelioma M*M# who had previously failed a first-
line chemotherapy.
(he magnitude of treatment effect increased with +,--h(+. duration and was particularly
mar$ed in patients receiving at least three months of therapy, with a median survival time
nearly doubled in patients treated with +,--h(+. compared to control patients/ 01.% vs
2.3 months, respectively.
&laudio 4ordignon, &hairman and &5' of MolMed, commented/ 6(he results presented at
AS&' on the efficacy of +,--h(+. in the treatment of the patient affected by the more
aggressive form of malignant pleural mesothelioma confirm, in a large *hase """ trial, the
therapeutic potential of this molecule already observed in *hase "" in chemo-resistant
s7uamous +S&! carcinoma, soft-tissue sarcoma, and ovarian carcinoma. 8aving been able
to e9tend the median survival time to more than 01 months in patients treated for at least
0: wee$s is a success for the study and, more important, offers the perspective of a relev-
ant clinical benefit to patients affected by the more aggressive form of mesothelioma.
(hese results represent for MolMed the basis to aggressively pursue the ne9t crucial steps
for the future of this molecule/ the definition of the best and fastest registration path, and
the identification of a suitable partner for offering to +,--h(+. the possibility to e9press
its full potential as an anti-cancer agent of broad application.;
(he data reported at AS&', mainly obtained in combination with either gemcitabine or
vinorelbine in a very aggressive and chemo-resistant disease, assume particular relevance
as they are confirmatory of the efficacy previously shown by +,--h(+. plus gemcitabine
in the first-line *hase "" study in s7uamous lung cancer patients.
.urthermore, +,--h(+. confirmed in this large patient population its very favourable tol-
erability profile in combination with the three different chemotherapeutic agents admin-
istered in this study gemcitabine, vinorelbine and do9orubicin#.
An additional two randomi)ed *hase "" studies reported at AS&' meeting clearly estab-
lished the effect of +,--h(+. on survival.
"n the four-arm randomi)ed *hase "" study in sarcoma patients, the low-dose wee$ly +,--
h(+. plus do9orubicin regimen induced a statistically significant doubled survival time, as
compared with the other schedules given at high dose in combination with do9orubicin or
as monotherapy at low or high dose. (he <-year survival rate with this schedule e9ceeded
40% and, notably, similar results were reported for both chemo-na=ve and pretreated pa-
tients, thus confirming the elevated +,--h(+. efficacy in more aggressive, chemo-resist-
ant disease.
"n the randomi)ed *hase "" study in resistant > refractory ovarian cancer patients, +,--h(-
+. in combination with an anthracycline improved overall survival in patients with normal
or high baseline lymphocyte counts, as compared to patients receiving an anthracycline
alone.
(a$en together, these clinical evidences are also consistent with the drug mechanism of
action, based on both an increased intratumoral chemotherapy upta$e and interaction with
host immune system.
A!out NGR-hTNF
+,--h(+. is a novel therapeutic agent for solid tumours which displays antitumor activity
through its specific binding to blood vessels feeding the tumour mass. +,--h(+. is being
investigated in a large clinical program, including a *hase """ trial in malignant pleural
mesothelioma second line#, a *hase "" trial in malignant pleural mesothelioma first-line
maintenance therapy# and five *hase "" trials in colorectal, lung small-cell and non-small-
cell#, liver and ovarian cancer, and soft tissue sarcomas.
+,--h(+. has been granted 'rphan ?rug designation for the treatment of mesothelioma
and liver cancer in both the 5@ and the @S.
(his press release is written in compliance with public disclosure obligations established by
&'+S'4 "talian securities A e9change commission# resolution no. 002B0 of 04 May 0222,
as subse7uently amended.
A!out "ol"ed
MolMed S.p.A. is a biotechnology company focused on research, development and clinical
validation of novel anticancer therapies. MolMedCs pipeline includes two antitumour thera-
peutics in clinical development/ (D, a cell-based therapy enabling bone marrow trans-
plants from partially compatible donors, in absence of post-transplant immune-suppres-
sion, in *hase """ in high-ris$ acute leu$aemiaE +,--h(+., a novel vascular targeting
agent, in *hase """ in malignant pleural mesothelioma and in *hase "" in si9 more indica-
tions/ colorectal, lung small-cell and non-small-cell#, liver and ovarian cancer, and soft tis-
sue sarcomas. MolMed also offers top-level e9pertise in cell and gene therapy to third
parties to develop, conduct and validate proFects from preclinical to *hase """ trials, includ-
ing scale-up and c,M* production of clinical-grade viral vectors, and manufacturing of pa-
tient-specific genetically engineered cells. MolMed is head7uartered at the San -affaele
4iomedical Science *ar$ in Milan, "taly. (he &ompanyCs shares are listed on the main mar-
$et M(A# of the Milan Stoc$ 59change. (ic$er -euters/ M!M?.M"#
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