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Press Release

 
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 Announce License Agreement for therapeutic candidate PCM-075 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... Read more
Ignyta's Updated Phase 1 Data on Safety, Anti-Tumor Activity and CNS Activity of Entrectinib in Cancers with TRK, ROS1 or ALK Fusions Published in Cancer Discovery Milan, Italy 9th February 2017 SAN DIEGO--(BUSINESS WIRE)-- Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that updated results from two Phase 1 trials of entrectinib—the company's investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions—were published in the... Read more
NMS Group partecipa al programma PhD ITalents e offre 6 posizioni altamente qualificate a giovani ricercatori Nerviano, Italia 2 Febbraio 2017 – Saranno sei i giovani Dottori in Ricerca che entreranno a far parte del Gruppo di Nerviano. La selezione è avvenuta nell’ambito di PhD ITalents, il progetto pilota gestito dalla Fondazione CRUI su incarico del MIUR ed in partenariato con Confindustria, nato con l’obiettivo di avvicinare il mondo accademico ed il mondo del lavoro, favorendo l’inserimento... Read more
Late-Breaking Oral Plenary Presentation of a Novel Entrectinib Combination Regimen at the 2016 EORTC-NCI-AACR Annual Meeting Nerviano, Italy 2nd December 2016SAN 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... Read more
Nerviano Medical Sciences presents data regarding a potent new cytotoxic molecule for ADC generation Nerviano, Italy 13th October 2016 – At the 7th World Summit focused on ADCs (San Diego, CA), Nerviano Medical Sciences presented new data regarding the immunoconjugate drugs field, an area of intense interest in the Oncology R&D sector. During the event NMS researchers described the targeted anticancer effects obtained in preclinical models with an ADC obtained by combining the thienoindole... Read more
MediaPharma Licenses Nerviano Medical Sciences’ Drug-Linker Technology to Develop Novel Antibody Drug Conjugate Reiden (Switzerland), Chieti (Italy) and Nerviano (Italy) – 07 September 2016 – MediaPharma (MP), a biotech company focusing on the discovery and development of monoclonal antibodies, bispecifics and antibody drug conjugates (ADCs) against new targets in oncology and Nerviano Medical Sciences (Nerviano), a company of the NMS Group dedicated to the discovery and development of breakthrough... Read more
La nostra Notte della Ricerca Nerviano, Italy 4th September 2016  Il lungo percorso di ricerca e sviluppo di un nuovo farmaco oncologico è il risultato di un affascinante lavoro di squadra, al quale contribuiscono diverse conoscenze, tecnologie e tanta passione. Per la Seconda Edizione della notte nervianese sarà possibile visitare i laboratori di Ricerca e assistere alle dimostrazioni pratiche in 3 diversi percorsi... Read more

Trovagene and Nerviano Announce License Agreement for therapeutic candidate PCM-075

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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