Milan (Italy), 12 November 2012 – 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 2012. The most important elements were:
- The analysis of the clinical trial progress: in particular the positive interim data of the randomised Phase II data of NGR-hTNF in combination with doxorubicin in soft tissue sarcomas;
- The increase of revenues to € 2.8 million from the development of new cell and gene therapy treatments for third parties;
- Approval of balance sheet and income statement pursuant to Art. 2446 of the Italian Civil Code.
Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: “The interim analysis of the randomised Phase II study of NGR-hTNF in soft tissue sarcomas shows a statistically significant superiority of the arm treated with the dose of 0.8 µg/sqm administered weekly in combination with doxorubicin. According to protocol design the study will continue enrolling patients only in this arm that has demonstrated superior progression free survival. These results confirm that the low dose administered weekly in combination with chemotherapy represents the most efficacious dose and schedule. This schedule is also being tested in the ongoing pivotal Phase III trial in mesothelioma and will be explored in the ongoing randomised Phase II study in ovarian cancer”.
Key achievements in the first nine months of 2012
Research & Clinical Development activities
In the first nine months of 2012, the Company’s activities were mainly focused on clinical development of its two investigational anticancer therapeutics: NGR-hTNF for the treatment of a panel of solid tumours and TK for the treatment of high-risk leukaemia.
With regard to NGR-hTNF, main progress achieved included:
- Progress of patient recruitment in the randomised pivotal Phase III trial for the treatment of relapsed malignant pleural mesothelioma (trial NGR015): over 300 patients were enrolled in more than 40 centres located in nine European countries, the United States, Canada and Egypt, with accrual completion expected by the end of 2012. The primary analysis of data is expected in 2H 2013;
- Presentation at ASCO (June 2012) and ESMO (October 2012) of long-term survival data in a randomised Phase II trial in non-small cell lung cancer (NSCLC, trial NGR014), confirming the potential clinical benefit in NSCLC patients with squamous cell histology. The extension of overall survival was the most common clinical benefit observed also in three other Phase II trials presented – in mesothelioma, ovarian cancer and small-cell lung cancer;
- Presentation of two analyses on potential predictors of efficacy. The results of the first analysis show in all indications a positive correlation between Grade 1 and 2 infusion-related adverse reactions (transient chills) and patients’ overall response to the therapy, which is in line with analogous findings observed with other anti-angiogenic or biological drugs. The second analysis shows a negative correlation between circulating TNF receptors and therapeutic response – consistently with the hypothesised mechanism of action of the drug – and also clarifies why low doses of NGR-hTNF are more efficacious than high doses.
Updates with regard to NGR-hTNF after 30 September 2012:
- Positive interim data from a randomised Phase II trial of NGR-hTNF in patients affected by soft tissue sarcomas (trial NGR016). The results from this four-arm trial, with a pick-the-winner design, confirm that low-dose NGR-hTNF (0.8 µg/sqm) administered weekly in combination with doxorubicin provides the highest clinical benefit to patients. With this schedule, the progression free survival resulted significantly prolonged, as compared to weekly high-dose NGR-hTNF (either in combination with doxorubicin or as monotherapy), and weekly low-dose NGR-hTNF as monotherapy. For this reason the trial will continue including new patients only in the treatment arm with low-doses of NGR-hTNF in combination with doxorubicin. These results further confirm that the dose of 0.8 µg/sqm administered weekly, tested also in the ongoing pivotal Phase III trial in mesothelioma, represents the optimal dose and schedule. Complete trial results are expected in 2H 2013;
- Completion of patient enrolment in a randomised Phase II trial in platinum-resistant/refractory ovarian cancer patients (trial NGR018). The study is evaluating low-dose NGR-hTNF (administered once every three weeks) in combination with the standard treatment (doxorubicin or pegylated liposomal doxorubicin) versus standard treatment alone. Based on the positive results obtained in the trial in soft tissue sarcomas, the Company has decided to assess the efficacy of weekly low-dose NGR-hTNF in combination with doxorubicin versus doxorubicin alone, and thus to extend the sample size by enrolling 30 additional patients, therefore bringing the total to 130. Preliminary trial results are expected in 2H 2013.
With regard to TK:
- With the aim to provide additional clinical benefit to patients, the Company implemented two important changes in the protocol design of Phase III trial TK008. The first change consists in broadening the enrolment criteria to include patients in leukaemic relapse, in addition to those in disease remission; the second change provides for the introduction of a further treatment option in the control arm, based on the use of an unmanipulated transplant followed by cyclophosphamide administration during the post-transplantation period. The Company estimates that those modifications double the number of eligible patients for each centre, and hopes that this will significantly increase the potential number of participating centres. First two prestigious U.S. centres have been authorised and are ready to start enrolment. Moreover, the new version of the protocol has already been implemented in the majority of centres involved in the trial;
- Efficacy data gathered so far led the Company to prepare a request for market approval through an accelerated procedure (Conditional Marketing Authorisation). This request is based on the favourable risk/benefit rate, the demonstration of safety and clinical efficacy and the rarity of the indication (TK has obtained the Orphan Drug designation). The Company expects to file this request to the European authorities in mid-2013.
Development and GMP production for third parties
Development and production 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 significant increase in revenues (as described in the Comments to financials). During the first nine months of 2012, 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.
The official Corporate Financial Reporting Manager of MolMed S.p.A., Enrico Cappelli, herewith attests, pursuant to Article 154-bis, paragraph 2 of the Italian Consolidated Law on Finance (Legislative Decree 58/1998), that the accounting disclosure contained in this press release matches documentary evidence, corporate books, and accounting records.
In this press release, use is made of “alternative performance indicators” which are not provided for under European IFRS, and whose significance and content – in line with Recommendation CESR/05-178b published on 3 November 2005 – are illustrated below:
- Operating Result: defined as the difference between sales revenues and other income and costs for materials, costs of services received, costs for use of third-party assets, personnel costs and amortisation, depreciation & write downs. It represents the profit before financial flows and taxes;
- Net Financial Position: is the algebraic sum of cash, cash equivalents, financial receivables and other financial assets, and current and non-current financial debt.
This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14.5.1999, as subsequently amended.
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed’s pipeline includes two novel therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent (VTA), 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 Milan Stock Exchange, at the Standard segment (class I) of the MTA managed by Borsa Italiana. (Ticker Reuters: MLMD.MI)