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The report provides comprehensive information on the therapeutics under development for Malignant Pleural Mesothelioma, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Malignant Pleural Mesothelioma   and features dormant and discontinued projects. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. Complete report on Malignant Pleural Mesothelioma - Pipeline Review, H2 2016 addition with 55 market data tables and 15 figures, spread across 315 pages is available at http://www.reportsnreports.com/reports/764553-malignant-pleural-mesothelioma-pipeline-review-h2-2016.html This report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, Investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis Advantagene, Inc.,Amphera BV,AnGes MG, Inc.,ArQule, Inc.,Bayer AG,Biogen Inc,Bionomics Limited,Biotecnol Limited,Boehringer Ingelheim GmbH,Boston Biomedical, Inc.,Bristol-Myers Squibb Company,CanBas Co., Ltd.,Concordia International Corp,Eli Lilly and Company,EnGeneIC Ltd,F. Hoffmann-La Roche Ltd.,Genelux Corporation,GlaxoSmithKline Plc,Juno Therapeutics Inc.,MedImmune LLC,Merck & Co., Inc. Inquire before buying http://www.reportsnreports.com/contacts/inquirybeforebuy.aspx?name=764553 premium report price at US$2000 for a single user PDF license).


Shirley L.A.,Ohio State University | Aguilar L.K.,Advantagene, Inc | Aguilar-Cordova E.,Advantagene, Inc | Bloomston M.,Ohio State University | Walker J.P.,Ohio State University
Gastroenterology Research and Practice | Year: 2013

Pancreatic adenocarcinoma is an aggressive disease that has poor outcomes despite maximal traditional therapies. Thus, treatment of this cancer demands innovative strategies to be used in addition to standing therapies in order to provide new avenues of care. Here, we describe the technique of using endoscopic ultrasound in order to directly inject both novel and conventional therapies into pancreatic tumors. We detail the rationale behind this strategy and the many benefits it provides. We then describe our technique in detail, including our experience injecting the AdV-tk adenoviral vector to create an in situ vaccine effect. © 2013 Lawrence A. Shirley et al.


Aguilar L.K.,Advantagene, Inc | Arvizu M.,Advantagene, Inc | Aguilar-Cordova E.,Advantagene, Inc | Chiocca E.A.,Brigham and Women's Hospital
Current Treatment Options in Oncology | Year: 2012

Glioblastoma multiforme (GBM) is the most common primary malignant tumor of the central nervous system (CNS) and one of the most lethal cancers in adults and children. Despite aggressive treatment with surgery, radiation, and chemotherapy, median survival is less than 15 months and overall survival is less than 10 % at 5 years. Development of therapeutics for malignant gliomas has been hampered by their natural complexity as well as protective mechanisms unique to the CNS. Better understanding of the pathogenesis of GBM is opening the path to novel, specific-targeted therapies. Recently, multiple immunotherapy approaches have been acquiring substantial indication of therapeutic efficacy with a very safe profile. Examples of the leading clinical approaches for GBM will be discussed in detail in this review. © Springer Science+Business Media, LLC 2012.


Aguilar L.K.,Advantagene, Inc | Guzik B.W.,Advantagene, Inc | Aguilar-Cordova E.,Advantagene, Inc
Journal of Cellular Biochemistry | Year: 2011

Traditional therapies for cancer include surgery, chemotherapy, and radiation. Chemotherapy has widespread systemic cytotoxic effects against tumor cells but also affects normal cells. Radiation has more targeted local cytotoxicity but is limited to killing cells in the radiation field. Immunotherapy has the potential for systemic, specific killing of tumor cells. However, if the immune response is specific to a single antigen, tumor evasion can occur by down-regulation of that antigen. An immunotherapy approach that induces polyvalent immunity to autologous tumor antigens can provide a personalized vaccine with less potential for immunologic escape. A cytotoxic immunotherapy strategy creates such a tumor vaccine in situ. Immunogenic tumor cell death provides tumor antigen targets for the adaptive immune response and stimulates innate immunity. Attraction and activation of antigen presenting cells such as dendritic cells is important to process and present tumor antigens to T cells. These include cytotoxic T cells that kill tumor cells and T cells which positively and negatively regulate immunity. Tipping the balance in favor of anti-tumor immunity is an important aspect of an effective strategy. Clinically, immunotherapies may be most effective when combined with standard therapies in a complimentary way. An example is gene-mediated cytotoxic immunotherapy (GMCI) which uses an adenoviral vector, AdV-tk, to deliver a cytotoxic and immunostimulatory gene to tumor cells in vivo in combination with standard therapies creating an immunostimulatory milieu. This approach, studied extensively in animal models and early stage clinical trials, is now entering a definitive Phase 3 trial for prostate cancer. Copyright © 2011 Wiley-Liss, Inc.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 225.00K | Year: 2014

Abstract Persistent injury to the liver can cause chronic inflammation and dysregulated deposition of extracellular matrix (ECM), leading to accumulation of fibrotic scar tissue and eventually cirrhosis. While fibrosis is a normal wound healing response, in excess, it can further injure tissue and activate pro-fibrotic cells, resulting in a positive feedback loop. Scar tissue is not static, ECM remodeling is a dynamic and regulated process that holds promise for targeted intervention of fibrotic disease. Furthermore, recent observations suggest the potential for the 'reversal' of advanced liver disease upon removal of the source of injury. In cirrhosis, aggressive removal of scar tissue would likely be needed to halt the positive feedback loop and create space for healthy hepatocyte growth. One hypothesis for achieving this is the introduction of ECM regulating enzymes, such as the collagenase Matrix Metalloprotienase-8 (MMP-8), thus shifting the balance of pro-fibrotic versus anti-fibrotic components, break


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 299.99K | Year: 2016

DESCRIPTION provided by applicant Pancreatic adenocarcinoma has a dismal year survival of andlt The only potential curative treatment is resection but this is achieved in andlt of patients and most still die due to micrometastases or residual disease Patients with unresectable disease receive palliative chemotherapy with a median survival of less than months This application proposes a multi pronged approach with an aggressive chemoradiation regimen combined with a viral immuno oncology product to attack residual and metastatic disease The goal is to increase the resection rate and year survival without further compromising quality of life The project builds on a completed Phase a trial with Gene Mediated Cytotoxic Immunotherapy GMCI combined with chemoradiation and surgery that established a safe dose level and demonstrated immune stimulation in pancreatic cancer GMCI generates a polyvalent anti tumor immune response through local delivery of aglatimagene besadenovec AdV tk plus prodrug and has demonstrated synergy with standard of care SOC in multiple tumor types In preclinical studies the CD T cell dependent systemic effect is potentiated by radiation chemotherapy and surgery which debulk and decrease immune inhibitory factors elicited by tumors GMCI significantly improved survival in a recent Phase study in combination with chemoradiation in malignant glioma patients that had received total resection A neoadjuvant regimen using modified FOLFIRINOX mFX followed by gemcitabine radiation GR was piloted by the investigators at OSU in borderline resectable BRPC and locally advanced pancreatic cancer LAPC The regimen showed equivalent efficacy with less toxicity than standard FOLFIRINOX and led to more patients becoming resectable Components of the regimen have been shown to suppress immune inhibitory factors elicited by tumors including myeloid derived suppressor cells MDSC regulatory T cells Treg and inhibitory cytokines These data support the rationale for combining GMCI with mFX GR surgical resection This Fast Track application proposes a Ph b clinical trial in BRPC and LAPC The clinical protocol has received all the necessary regulatory approvals and is ready to launch The protocol includes a single arm Phase Ib stage to establish the feasibility of the treatment plan Phase I segment of the Fast track grant followed by a randomized Phase stage of the trial Phase II grant segment Immune biomarkers including effector T cells Tregs MDSCs and cytokines will be measured before and after each treatment phase and compared between the control and test arm to better understand the mFX GR and GMCI immune effects in this patient population This will be the first study of an immunotherapy combined with mFX GR and the first randomized clinical study of GMCI for PanCa The goal is to obtain the necessary data to support a decision for or against a definitive efficacy study that may improve the outcomes for patients with this devastating disease The transition from Phase Ib to Phase II is preplanned in the protocol as a measurable milestone and will benefit from continuity thus the Fast Track submission PUBLIC HEALTH RELEVANCE Pancreatic adenocarcinoma has a year survival rate of less than the lowest of all major cancers with more than deaths in the US each year Pancreatic cancer is a major focus of the Recalcitrant Cancer Research Act recently passed to encourage research support for this deadly cancer This application proposes a multi pronged approach with an aggressive chemoradiation regimen combined with a viral immuno oncology product for pancreatic cancer The goal is to increase the resection rate and year survival without further compromising quality of life The project builds on a completed Phase a trial with Gene Mediated Cytotoxic Immunotherapy GMCI combined with chemoradiation and surgery that established a safe dose level and demonstrated immune stimulation in pancreatic cancer This Fast Track grant proposal seeks to build on these results with a follow on Phase b clinical trial Our clinical objective is to increase the number of patients that may undergo potentially curative resections and prevent development of metastases thus potentially achieve long term clinical benefit Our commercial goal is to develop a new therapeutic product for pancreatic cancer


Trademark
Advantagene, Inc | Date: 2014-04-08

Pharmaceutical products for the prevention and treatment of cancer; Pharmaceutical products for the treatment of viral and infectious diseases, for the treatment of cancer.


Trademark
Advantagene, Inc | Date: 2014-03-26

Pharmaceutical products for the prevention and treatment of cancer; Pharmaceutical products for the treatment of viral and infectious diseases, for the treatment of cancer.


PubMed | Advantagene, Inc
Type: Clinical Trial | Journal: Cancer immunology, immunotherapy : CII | Year: 2015

While surgical resection of pancreatic adenocarcinoma provides the only chance of cure, long-term survival remains poor. Immunotherapy may improve outcomes, especially as adjuvant to local therapies. Gene-mediated cytotoxic immunotherapy (GMCI) generates a systemic anti-tumor response through local delivery of an adenoviral vector expressing the HSV-tk gene (aglatimagene besadenovec, AdV-tk) followed by anti-herpetic prodrug. GMCI has demonstrated synergy with standard of care (SOC) in other tumor types. This is the first application in pancreatic cancer.Four dose levels (310(10) to 110(12) vector particles) were evaluated as adjuvant to surgery for resectable disease (Arm A) or to 5-FU chemoradiation for locally advanced disease (Arm B). Each patient received two cycles of AdV-tk+prodrug.Twenty-four patients completed therapy, 12 per arm, with no dose-limiting toxicities. All Arm A patients were explored, eight were resected, one was locally advanced and three had distant metastases. CD8(+) T cell infiltration increased an average of 22-fold (range sixfold to 75-fold) compared with baseline (p=0.0021). PD-L1 expression increased in 5/7 samples analyzed. One node-positive resected patient is alive >66months without recurrence. Arm B RECIST response rate was 25% with a median OS of 12months and 1-year survival of 50%. Patient-reported quality of life showed no evidence of deterioration.AdV-tk can be safely combined with pancreatic cancer SOC without added toxicity. Response and survival compare favorably to expected outcomes and immune activity increased. These results support further evaluation of GMCI with more modern chemoradiation and surgery as well as PD-1/PD-L1 inhibitors in pancreatic cancer.


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