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Nerviano Medical Sciences presenta un'estesa caratterizzazione genomica del CORDOMA Nerviano, Italia 7 Novembre 2017 - Appena pubblicati su un'importante rivista scientifica e presentati all’EMBL Conference in corso a Heidelberg, in Germania, i risultati di un’estesa caratterizzazione del profilo genetico del cordoma, un raro tumore maligno localmente aggressivo ed invasivo, che rappresenta l’1-4% dei tumori ossei e si localizza lungo la colonna vertebrale, principalmente... Read more
Trovagene Announces Manufacturing Agreement with NerPharMa for Supply of PCM-075 for AML Trial San Diego 29 giugno 2017 - Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced it has executed a supplier agreement with NerPharMa, S.r.l., a pharmaceutical manufacturing company and a subsidiary of Nerviano Medical Sciences S.r.l., in Milan, Italy, to manufacture drug product for PCM-075. Read Read more
Ignyta Granted Breakthrough Therapy Designation for Entrectinib by U.S. Food and Drug Administration San Diego, May 15th 2017 - Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation (BTD) to entrectinib "for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either... Read more
Al prossimo AACR Nerviano Medical Sciences presenterà le novità su due efficaci nuovi inibitori oncologici, selettivi e tollerati Nerviano, 31 marzo 2017 – Con un track record di 8 molecole licenziate in sei anni ed una robusta pipeline con diversi esempi dell’oncologia di precisione, il Campus di Nerviano Medical Sciences può vantare anche progetti in ricerca preclinica che stanno avanzando con successo e che rappresentano le prospettive future. Le nuove evidenze al prossimo Meeting dell’American Association for Cancer... Read more
Trovagene and Nerviano annunciano un accordo di licenza per PCM-075/NMS-P937 Nerviano, Italia (15 Marzo, San Diego, CA Trovagene, Inc. NASDAQ: TROV) - Oggetto del deal è PCM-075 (NMS-P937), un potente e selettivo inibitore orale di Plk1 (una chinasi sovraespressa in diversi tipi di tumore tra i quali quello del seno, della prostata, dell'ovaio, del polmone, dello stomaco e del colon, nonché nelle neoplasie ematologiche) per il quale è rilevante la corretta... Read more
Dalla ricerca italiana contro il cancro alla sperimentazione mondiale: i dati che comprovano l' efficacia del farmaco appena pubblicati su 'Cancer Discovery' Milano, Italia 9 Febbraio 2017 – Nuovi dati confermano l’efficacia, per diversi tipi di tumore, del farmaco “made in Italy” entrectinib, una molecola nata dalla ricerca italiana del Centro Ricerche di Nerviano e per il quale lo sviluppo clinico era stato avviato al Niguarda Cancer Center e all'Istituto Nazionale dei Tumori, per poi essere espanso su scala mondiale grazie all'azienda... Read more
Late-Breaking Oral Plenary Presentation of a Novel Entrectinib Combination Regimen at the 2016 EORTC-NCI-AACR Annual Meeting SAN DIEGO--(BUSINESS WIRE)-- Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced data examining the combination of entrectinib and trametinib in overcoming resistance to TRK inhibition during a late-breaking oral plenary presentation (during the Exceptional Response and Expected Resistance Session) at the 2016 EORTC-NCI-AACR (ENA)... Read more
Nerviano Medical Sciences: Presentati all'‘ADC SUMMIT’ i risultati di un nuovo potente cititossico per la generazione di ADC (Antibody Drug Conjugates) Nerviano, Italia 13 ottobre 2016 – Al Settimo Summit mondiale dedicato interamente alla Ricerca e Sviluppo di nuovi ‘ADC’ (Antibody Drug Conjugates) in corso a San Diego, i ricercatori di Nerviano Medical Sciences hanno presentato i risultati molto rilevanti ottenuti nell’innovativo campo di ricerca degli ADC. In particolare, hanno evidenziato gli effetti antitumorali mirati ottenuti in modelli... Read more

Trovagene and Nerviano annunciano un accordo di licenza per PCM-075/NMS-P937

Nerviano, Italia (15 Marzo, San Diego, CA Trovagene, Inc. NASDAQ: TROV) - Oggetto del deal è PCM-075 (NMS-P937), un potente e selettivo inibitore orale di Plk1 (una chinasi sovraespressa in diversi tipi di tumore tra i quali quello del seno, della prostata, dell'ovaio, del polmone, dello stomaco e del colon, nonché nelle neoplasie ematologiche) per il quale è rilevante la corretta identificazione del paziente in target. Grazie a PCM-075 (NMS-P937), attualmente in fase 1 della clinica, Trovagene avvierà un iniziale programma di sviluppo nei pazienti con leucemia mieloide acuta.

Nerviano, Italy (March 15, San Diego, CA Trovagene, Inc. NASDAQ: TROV) - Trovagene, a precision medicine biotechnology company and Nerviano Medical Sciences, S.r.l., a leading oncology discovery organization, today announced that they have signed a license agreement that grants Trovagene exclusive global development and commercialization rights to NMS-1286937, which Trovagene refers to as PCM-075. PCM-075 is an oral, investigative drug and a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1).

“We are excited to license PCM-075 and look forward to beginning a development program in patients with acute myeloid leukemia (AML),” said Bill Welch, CEO of Trovagene. “This transaction allows Trovagene to execute on our strategy to vertically integrate our ctDNA Precision Cancer Monitoring® (PCM) technology with precision cancer therapeutics by developing drugs where our deep understanding of tumor genomics may allow for effective targeting of appropriate cancer patients.”

“We are very pleased to start a collaboration with Trovagene, a world leader in precision medicine,” said Andrea Agazzi, President of the NMS Group. “Both Nerviano and Trovagene share the common goal of developing innovative new drugs for cancer patients. We're proud of this new important agreement as a further confirmation of our commitment to develop high level innovation through partnering. Our continuously increasing track record involves, in fact, companies at a worldwide level like Trovagene.”

Under the terms of the license agreement, Trovagene will assume sole responsibility for global development and commercialization of PCM-075. Nerviano will receive an upfront payment of $2.0 million, as well as development and regulatory-based milestone payments and royalty payments on future net sales of PCM-075. Nerviano is the current manufacturer for bulk and finished drug for PCM-075 and Trovagene has all rights to manufacture bulk and finished goods.

PLK1 is over-expressed in several different tumor types, including breast, prostate, ovarian, lung, gastric and colon cancers, as well as hematological malignancies. A phase 1 safety study of PCM-075 was successfully completed in patients with advanced metastatic disease. Trovagene plans to develop PCM-075 initially in AML, where both Trovagene and Nerviano believe PCM-075’s target selectivity for PLK1, along with its oral availability, and shorter half-life as compared to other polo-like-kinase inhibitors, may be advantageous features of the drug.

Trovagene has significant experience and expertise with biomarkers and technology in cancer, including AML. Trovagene is the patent holder of NPM1 for diagnosis and monitoring of patients. NPM1-mutated AML is a founder genetic marker in leukemia and accounts for approximately one-third of all AML patients. Trovagene will use its PCM technology to profile other dominant AML markers, such as FLT3, DNMT3A, NRAS, and KIT, to identify and measure patient therapy response.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Trovagene's expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene's strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Trovagene's Form 10-K for the year ended December 31, 2016 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

 
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