MolMed TK: BoD approves the interim financial report at 31 March 2013
MolMed Board of Directors approves the interim financial report at 31 March 2013.
- (1888PressRelease) May 20, 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 31 March 2013. The most important elements were:
- progress on dossier preparation to file a market authorisation application for TK through the Conditional Marketing Authorisation procedure with the European Medicines Agency;
- continuation of ongoing clinical trials both for TK and NGR-hTNF.
Key achievements in the first three months of 2013
Research & Clinical Development activities
In the first three months of 2013, the Company's activities were mainly focused on the clinical development of its two investigational anticancer therapeutics: TK for the treatment of high-risk leukaemia and NGR-hTNF for the treatment of a panel of solid tumours.
With regard to TK, main progress achieved during the first quarter 2013 include:
- progress on dossier preparation to file a market authorisation application for TK through a specific 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 rate and the demonstration of safety and clinical efficacy obtained in more than 120 patients treated so far. The Company expects to file this request to the European authority in 2013;
- presentation of positive results on the contribution given by TK to the treatment of haematological malignancies through bone marrow transplantation from partially matched donors (haplo-identical transplants) at the Blood & Marrow Transplantation (BMT) Tandem Meetings, the combined annual meeting of the Center for International Blood & Marrow Transplant Research (CIBMTR) and the American Society of Blood & Marrow Transplantation (ASBMT). The study reveals that results of transplants from partially matched family donors are fully comparable, in terms of overall survival and disease-free survival, to those obtained with transplants from fully matched donors. These results are of particular relevance in light of the fact that this type of transplant is available for almost all patients: over 80% of the intention to treat population actually received a transplant.
With regard to NGR-hTNF, main progress achieved during the first quarter 2013 include:
- completion of patient enrolment in a randomised Phase II trial of NGR-hTNF in patients affected by soft tissue sarcomas (trial NGR016). Given the results obtained from an interim analysis performed in 2012 - which confirmed that low-dose NGR-hTNF (0.8 µg/sqm) administered weekly in combination with doxorubicin provides the highest clinical benefit to patients - recruitment was completed including patients only in the treatment arm with low-doses of NGR-hTNF in combination with doxorubicin. Complete trial results are expected in 2H 2013;
- continuation of patient enrolment in a randomised Phase II trial for the treatment of platinumresistant/refractory ovarian cancer patients (trial NGR018) with NGR-hTNF administered according to previously identified optimal schedule (weekly treatment) and in a randomised Phase II trial in malignant pleural mesothelioma with NGR-hTNF given as first-line maintenance therapy (trial NGR019).
Development and GMP production for third parties
Development and production activities of new cell and gene therapy treatments performed for third parties are consolidating the company's technological leadership in this field, and are also generating a further increase in revenues compared to what was highlighted in FY2012.
During the first three months of 2013, work continued under two major agreements signed in 2011, respectively with Telethon Foundation and GlaxoSmithKline, for the development and production of investigational gene therapies for a total of seven rare diseases. In addition, work has been carried out to upgrade and optimise the GMP production facility
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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)
Source: MolMed
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