Sentences with phrase «investigational cell»

His laboratory (The Laboratory for Cell and Gene Medicine) specializes in the development of manufacturing processes and QC assays and provides cGMP compliant clinical materials production and regulatory support activities for investigational cell products.

«Does that mean that people are getting access to safe and efficacious interventions or is there basically unapproved human experimentation taking place where people are going to these businesses and receiving experimental investigational cell - based interventions without being given a meaningful account of the lack of knowledge and evidence that they're being charged for?»

Not exact matches

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

Announced a clinical trial collaboration with Pfizer, Inc. (Pfizer) to evaluate the safety and efficacy of the investigational combination of Yescarta and Pfizer's utomilumab, a fully humanized 4 - 1BB agonist monoclonal antibody, in patients with refractory large B - cell lymphoma.

Cambridge, MA — February 6, 2017 — Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for the company's lead program, light - activated AU - 011 in ocular melanoma (OM).

Cambridge, MA — March 30, 2017 — Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that it has enrolled and dosed the first patient in its Phase 1b clinical trial of light - activated AU - 011, an investigational, first - in - class targeted therapy in development for the treatment of ocular melanoma, a rare and life - threatening disease.

Along with the study's co-first authors, Drs. Aayoung Hong and Gatien Moriceau, Lo hypothesized that if they could identify the key tumor cell processes triggered by withdrawal of MAPK inhibitors, then scientists can exploit these process with existing or investigational drugs to trigger the maximal levels of tumor cell death immediately following cessation of the initial therapy.

The scientists identified several, including the investigational cancer drug BEZ235, which blocked a key metabolic pathway in flu - infected human lung epithelial cells.

Phase I / II clinical trial results reported at the American Society for Clinical Oncology (ASCO) Annual Meeting 2015 show promising results for investigational drug brigatinib against ALK + non-small cell lung cancer (NSCLC), with 58 of 78 ALK + patients responding to treatment, including 50 of 70 patients who had progressed after previous treatment with crizotinib, the first licensed ALK inhibitor.

Treatment with an investigational CAR T - cell therapy induced complete remission of a brain metastasis of the difficult - to - treat tumor diffuse large - B - cell lymphoma (DLBCL), which had become resistant to chemotherapy — the first report of a response to CAR T - cells in a central nervous system lymphoma.

We have found that exosomes and the cargo they contain are crucial mediators of stem cell - based heart regeneration, and we believe this might lead to an even more refined therapy using the «active ingredient» instead of the entire stem cell,» said Eduardo Marbán, MD, PhD, director of the Cedars - Sinai Heart Institute and a pioneer in developing investigational cardiac stem cell treatments.

«Identifying targets essential to cell survival in tumor suppressor genes has long been an investigational goal with the aim of offering cancer - specific vulnerabilities for targeted therapy,» said Ronald DePinho, M.D., professor of Cancer Biology, MD Anderson president, and senior author for the Nature paper.

A study publishing October 1 in Cell Stem Cell reveals why these symptoms arise and tests an investigational drug in mice that could prevent them from developing.

He has initiated multiple trials under investigational new drug applications using infused T cells and natural killer (NK) cells.

The device, part of the Lab's iCHIP (in - vitro Chip - Based Human Investigational Platform) project, simulates the central nervous system by recording neural activity from multiple brain cell types deposited and grown onto microelectrode arrays.

Results of a phase one trial show that an investigational topical drug, resiquimod gel, causes regression of both treated and untreated tumor lesions and may completely remove cancerous cells from both sites in patients with early stage cutaneous T cell lymphoma (CTCL)-- a rare type of non-Hodgkin lymphoma that affects the skin.

The investigational treatment was combined with chemotherapy and an autologous stem cell transplant — a new strategy designed to target and kill the cells that give rise to myeloma cells.

In their report published in Cancer Immunology Research, a team from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH) describes how adding AMD3100 (plerixafor)-- previously approved for the stimulation of stem cell production prior to bone marrow transplantation — to their investigational drug VIC - 008 more than doubled the animals» survival time.

Those findings are among results of six studies of investigational chimeric antigen receptor (CAR) T cells for both adult and pediatric leukemias, adult lymphomas, and ovarian cancer which will be presented during the 2016 American Society of Clinical Oncology Annual Meeting.

Along with the investigational monoclonal antibody, study participants underwent multi-drug chemotherapy, surgery, radiation and autologous hematopoietic stem cell transplantation.

Her expertise includes optimization of standard operating procedures for cGMP manufacture of transgenic T cells, stem cells and dendritic cells to be used in clinical trials, planning and writing clinical trial protocols, IND (investigational new drug) applications and other regulatory documents.

We have performed over 2,000 procedures and we are accepting subjects today for investigational stem cell treatments.

After colleagues at Sanofi provided an investigational compound that activates PKM2, the team showed that this compound could stop abnormalities in mouse podocytes both in cell culture and in two mouse models of diabetes.

In close collaboration with universities and physicians world - wide, our comprehensive investigational stem cell treatments employ well - targeted combinations of allogeneic human umbilical cord stem cells, autologous bone marrow stem cells, and autologous adipose stem cells for the diseases listed below.

Human embryonic stem cellsImage: Wikimedia commons, Nissim Benvenistylinkurl: Advanced Cell Technology; http://www.advancedcell.com/ (ACT) filed an Investigational New Drug (IND) application yesterday (November 18) to conduct a phase I / II trial using hESCs to treat a genetic eye disease.

According to Whitehead Institute researchers, a protein known as monocarboxylate transporter 1 (MCT1), which is highly expressed in a subset of metabolically altered cancer cells, is needed for the entry of the investigational cancer drug 3 - bromopyruvate (3 - BrPA) into malignant cells.

According to Diaz - Meco, when the researchers used an investigational drug that targets MDMs, they were able to prevent cancer progression in mice, and even restore normal pancreatic cell identity.

Myelosuppression is a well - established side effect of current AML therapies, with prolonged events leading to an increased risk of infections and death.44 Consequently, therapies that preferentially kill leukemic cells over normal bone marrow cells are urgently required, and the overexpression of CD123 on AML leukemic stem cells and blasts compared with normal hematopoietic cells contributes to its attractiveness as a therapeutic target in this disease.6, 45 However, severe myelosuppression and myeloablation have emerged for some investigational CD123 - targeted treatment modalities.