Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 34 n° 316

Posts Tagged ‘therapies’

Oncology therapies

Posted by fidest press agency su lunedì, 9 settembre 2019

Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, is developing poziotinib in non-small cell lung cancer (NSCLC) EGFR exon 20 mutations and beyond. New clinical data from the poziotinib Phase 2 investigator-initiated trial in NSCLC EGFR exon 20 mutations, conducted by the University of Texas MD Anderson Cancer Center will be presented during the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer taking place in Barcelona, Spain from September 7-10, 2019. “There continues to be investigator interest in poziotinib’s unique characteristics to address NSCLC mutations, including exon 20 and other mutations, which have limited or no treatment options,” said Francois Lebel, M.D., F.R.C.P.C., Chief Medical Officer of Spectrum Pharmaceuticals. “The data presented at this conference by our scientific collaborators at MD Anderson further expands the body of evidence supporting poziotinib’s role in lung cancer and helps us gain new insights into its full potential.”

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Strategic Collaboration to Develop Novel Therapies for Fibrotic Diseases

Posted by fidest press agency su venerdì, 21 dicembre 2018

Gilead Sciences, Inc. (NASDAQ: GILD) and Scholar Rock Holding Corporation (NASDAQ: SRRK) announced today that the companies have entered into a strategic collaboration to discover and develop highly specific inhibitors of transforming growth factor beta (TGFβ) activation for the treatment of fibrotic diseases.Under the collaboration, Gilead has exclusive options to license worldwide rights to product candidates that emerge from three Scholar Rock TGFβ programs: inhibitors that target activation of latent TGFβ1 with high affinity and specificity, inhibitors that selectively target activation of latent TGFβ1 localized to extracellular matrix, and a third TGFβ discovery program. Scholar Rock is responsible for antibody discovery and preclinical research through product candidate nomination, after which, upon exercising the option for a program, Gilead will be responsible for the program’s preclinical and clinical development and commercialization. Scholar Rock retains exclusive worldwide rights to discover, develop, and commercialize certain TGFβ inhibitors for oncology and cancer immunotherapy.In connection with the collaboration agreement, Scholar Rock will receive $80 million in upfront payments, comprised of $50 million cash and $30 million purchase of Scholar Rock Holding Corporation common stock. In addition, Scholar Rock will receive a one-time milestone payment of $25 million upon the successful completion of specific preclinical studies and be eligible to receive up to an additional $1,425 million in potential payments aggregated across all three programs based on the successful achievement of certain research, development, regulatory and commercialization milestones. Scholar Rock would also receive high single-digit to low double-digit tiered royalties on sales of potential future products originating from the collaboration.
Fibrosis is a debilitating pathological feature of many diseases that scars tissues and vital organs and is a major cause of morbidity and mortality. TGFβ-driven signaling is thought to be a central regulator of fibrosis. Inhibitors of TGFβ signaling discovered through Scholar Rock’s proprietary platform have been shown to selectively prevent the activation of the growth factor in the fibrotic matrix in vitro and in preclinical models. By targeting the disease microenvironment, these highly specific inhibitors of TGFβ activation may offer a novel approach to suppressing pro-fibrotic signaling in multiple organs.

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Therapies for Patients with Serious Liver Disease

Posted by fidest press agency su sabato, 15 dicembre 2018

Perspectum Diagnostics and the SC Liver Research Consortium (SCLRC) are delighted to announce a collaboration to advance clinical development of investigational therapies. This will focus on patients with serious liver diseases including non-alcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH) and hepatocellular carcinoma (HCC).SCLRC is a site management organization consisting of over 85 clinical sites based in the United States with specialized expertise in hepatology. SCLRC has successfully executed phase 1-3 trials in hepatitis C, hepatitis B, NASH, cirrhosis and HCC. SCLRC offers sponsors guidance in clinical development, as well as the recruitment and execution of clinical trials for regulatory approvals.Perspectum are imaging experts in Magnetic Resonance Imaging (MRI) and provide specialized imaging clinical research services in NASH, cholestatic liver disease and HCC. Their products, LiverMultiScanTM (which includes MRI-PDFF) and MRCP+, for quantitative imaging of the liver and biliary tree, and their comprehensive imaging CRO services have been included in over 18 phase 1-3 studies since their launch in 2014.With these complementary offerings, SCLRC and Perspectum will build a major US-based network setting a new standard for sponsors, both Pharmaceutical and Biotech companies. This network will be focused on clinical development of drugs and diagnostics for patients with liver disease. SCLRC currently has 45 clinical sites with access to Perspectum’s imaging-technology, with plans to enable the majority of clinical sites by June 2019.“We believe that this unique partnership will bring together novel technologies with deep clinical development experience to address high unmet medical needs for patients with liver disease,” according to Dr Cathy O’Hare, Head of US operations for Perspectum, based in South San Francisco. Professor Sir Michael Brady, Chairman of the Perspectum Board went further: “Perspectum Diagnostics, with technology that builds on decades of academic research at the University of Oxford, is changing the paradigm for clinical development in liver disease. We have the opportunity to develop drugs for diseases that to date have had no approved therapies, because we have the unique ability to demonstrate the benefits of investigational agents on imaging biomarkers.” Dr. Paul Pockros, Head of SCLRC and the Director of the Liver Disease Center at Scripps Clinic comments: “The collaboration between SC Liver Research Consortium and Perspectum will provide investigators and sites with an important technology to allow breakthroughs in NASH research. We believe this relationship will be beneficial for patients and physicians alike.”

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Vineti, Inc., the leading digital “platform of record” for personalized therapies

Posted by fidest press agency su sabato, 24 novembre 2018

Tessa Therapeutics (Tessa), an international clinical stage biopharmaceutical company focusing on cellular immunotherapy treatments for cancer, is a leading developer of personalized T cell therapies for solid tumors, including head and neck cancers and cervical cancer. Vineti provides the leading digital software platform to align and manage the complex personalized cell therapy process, safely and efficiently.The goal of the partnership is to scale Tessa’s therapies world-wide in a safe and efficient manner, supporting both late clinical stage therapies approaching commercialization and early-phase therapies progressing through various clinical stages. Tessa, headquartered in Singapore, brings international expertise through both its Asia operations and its global treatment network.Tessa’s Virus-Specific T cell (VST) technology is showing compelling results and an excellent safety profile in the treatment of cancer. The company is currently conducting a multi-center Phase III trial targeting nasopharyngeal cancer, and a Phase I trial targeting cervical cancer and oropharyngeal cancer, set to move into Phase II in 2019. In addition, Tessa is developing a broad pipeline of pre-clinical therapies targeting major cancers such as liver and lung using its VST platform.Vineti’s platform will support Tessa as it builds its pipeline of therapies and prepares for commercialization, with a focus on providing a digital orchestration platform to track, trace, align, and simplify the complex journey that underlies each therapy’s personalized operations and logistics chain. Vineti is now supporting patients and clinicians in more than 65 leading medical centers, and is rapidly expanding to Asia-Pacific and Europe.

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Researchers at Children’s Hospital Los Angeles Investigate New Combination Therapies to Treat Advanced Neuroblastoma

Posted by fidest press agency su mercoledì, 3 ottobre 2018

A phase 2 clinical trial has found that combining a novel compound called alisertib with chemotherapy has anti-tumor activity in children with high-risk, relapsed neuroblastoma. The New Approaches to Neuroblastoma Therapy (NANT) consortium study was led by Araz Marachelian, MD, MS, of the Children’s Center for Cancer and Blood Diseases at Children’s Hospital Los Angeles and Steven G. DuBois, MD, of the Dana-Farber Cancer Institute. Results were recently published online in the journal Clinical Cancer Research.In the multicenter trial, alisertib was combined with two common chemotherapy agents: irinotecan and temozolomide. Alisertib is an experimental compound that targets and inhibits a particular enzyme—called an Aurora A kinase—which neuroblastoma tumors often use to grow.
Neuroblastoma is the second most common solid tumor in children (after brain tumors). The cancer arises in immature nerve cells called neuroblasts, and it typically affects children ages 5 or younger. Nearly half of patients are diagnosed with high-risk, metastatic disease, which has a 50 percent mortality rate.The NANT study—a follow-up to an earlier phase 1 trial—evaluated the combination therapy in a group of 20 patients with high-risk neuroblastoma that had relapsed or had not responded to standard treatment. Of those patients, 21 percent had an objective response rate, showing significant improvement in all cancer sites in their body. One-year progression-free survival was 34 percent.Researchers had been hoping that the therapy would be particularly effective for children whose tumors have a gene called MYCN that is over-expressed, or “amplified.” Aurora kinases stabilize a key protein in MYCN, so researchers had aimed to disrupt that protein with alisertib—and potentially increase treatment effectiveness. MYCN amplification occurs in about 25 percent of neuroblastoma patients, and it is associated with more aggressive disease and poorer outcomes.In addition, the trial was the first to evaluate a liquid form of alisertib in children. A separate group of 12 patients in the study received this oral solution as part of the combination therapy, instead of a tablet form of the drug.
Researchers plan to continue to target the aurora kinase pathway in neuroblastoma studies. NANT, a group of 14 North American pediatric cancer centers, is the only consortium in the world solely dedicated to developing novel treatments and biomarkers through early clinical trials for neuroblastoma. Additional contributors include Yael P. Mosse, Elizabeth Fox, Rachel A. Kudgus, Joel M. Reid, Renee McGovern, Susan Groshen, Rochelle Bagatell, John M. Maris, Clare J. Twist, Kelly Goldsmith, M. Meaghan Granger, Brian Weiss, Julie R. Park, Margaret E. Macy, Susan L. Cohn, Greg Yanik, Lars Wagner, Randall Hawkins, Jesse Courtier, Hollie Lai, Fariba Goodarzian, Hiroyuki Shimada, Najee Boucher, Scarlett Czarnecki, Chunqiao Luo, Denice D. Tsao-Wei and Katherine K. Matthay.

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Personalized Immune-based Therapies for Colon and Pancreatic Tumors

Posted by fidest press agency su sabato, 9 giugno 2018

CENTOGENE, the worldwide leader in using genetic and proteomic knowledge to enable patients, clinicians and pharmaceutical partners to identify and accelerate treatments for rare diseases, today announced partnering with the Medical Faculties of the Universities of Greifswald and Rostock for the research project, “Development of diagnostic tools for personalized immune-based therapies for colon and pancreatic tumors.” CENTOGENE is committed to developing a fast-track diagnostic workflow which lays the groundwork for individualized vaccination therapy in cancer.
CENTOGENE’s competitive approach to combine results from extensive analysis of genomics, transcriptomics and peptidomics/proteomics (summarized under the term “multi-omics”) enables the company to identify highly relevant changes specific to the individual tumor. Merging the multi-omics analysis with its clinical bioinformatics competencies will enable the development of a non-invasive diagnostic tool and a predictive bioinformatics platform for individualized tumor vaccination.CENTOGENE will conduct genetic profiling of each individual cancer to identify immuno-relevant mutations and identify tumor-specific biomarkers aimed at early differential diagnosis and therapy monitoring.Pancreatic and colon cancer are among the most common tumors. Due to a high diversity of mutations that are responsible for the development and emergence of the cancer, the 5-year survival rate for pancreatic cancer was only 9% in 2017i. This research project concentrates on a patient’s need for a tailored drug to help their immune system to efficiently target the cancer cells.

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European dermatologists discuss the newest therapies and innovations on skin health

Posted by fidest press agency su venerdì, 20 aprile 2018

Barcelona More than 800 dermatologists and professionals related to skin health from all around Europe have gather in the 11th Skin Academy, organized by Almirall in Barcelona (Spain), a highly regarded and established medical dermatology forum focused on the Science of the skin. Attendees discussed about the newest skin health therapies and the latest innovations for psoriasis, skin cancer, infectious and inflammatory skin diseases as well as the most recent studies and their relevance to clinical practice.
Prof. Dr. Diamant Thaçi, M.D., Professor of Dermatology and Venereology at Comprehensive Center for Inflammation Medicine (CCIM) from University Medical Center Schleswig-Holstein in Lubeck (Germany), Chairman of the 11th Skin Academy, pointed out the importance of this sort of medical meeting where renowned experts share their expertise about the challenges and innovations related to the Science of the skin.
Scientific innovations in different skin health diseases were evaluated, whereas psoriasis was remarked including the news about fumaric acid esters (FAE) or how to apply translational medicine strategies to treat psoriasis.
The meeting provided perspectives on conventional systemic treatments that still represent a mainstay for the treatment of psoriasis. In this class of substances, FAEs are an established treatment, with long-term clinical experience in Germany. FAEs are currently an option as a first line therapy in the EU psoriasis guidelines. In 2017, the European Commission gave its positive opinion on dimethyl fumarate (DMF), which is being launched throughout Europe.
Concerning biologic treatments for this disease, different classes were presented in the sessions of the Forum, including the novel class of IL-23 inhibitors. Experts insisted on the importance of a better understanding of the pathogenesis of psoriasis, and researching treatments with an improved safety profile to reach unmet needs in the long-term management of patients.
This medical meeting also aimed to introduce new useful tools under evaluation for assessing actinic keratosis (AK) severity like the “Actinic Keratosis Area and Severity Index” (AKASI). Recent evidence on AK therapies was also presented and experts assessed the available evidence of comparative efficacy of topical and ablative treatments, the use of combination therapies, and potential future treatments in development.A faculty of international experts also reviewed the international guidelines, which vary in their recommendations as to whether all lesions require treatment, beyond advice on photoprotection, as there is clear evidence that AKs are markers for skin cancer.
Other hot topics were discussed such as dermoscopy in nail conditions, challenges in diagnosis of onychomycosis, new therapies for hair loss, latest news on acne vulgaris and rosacea, immunopathogenesis in atopic dermatitis and cosmetic procedures for dermatologic conditions.

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