Sentences with phrase «cell product candidate»
To that end, he said, Juno intends next year to launch a trial with a defined cell product candidate in adult ALL.
https://www.genengnews.com/
Juno asserted that the clinical hold on the ROCKET trial did not affect plans for its other CD19 - directed CAR T - cell product candidates, including JCAR017, for which the company has launched two clinical trials now recruiting patients.
At this time, trials and plans for its other CD19 - directed chimeric antigen receptor (CAR) T - cell product candidates, including JCAR017, are not affected.
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).
JCAR015 is a CD19 - directed chimeric antigen receptor technology (CAR - T) product candidate that has been under study in ROCKET in adult patients with relapsed or refractory B - cell acute lymphoblastic leukemia.
Juno is developing its immunotherapy product candidate, JCAR017, which is in a Phase I trial, studying patients with B - cell Non-Hodgkin Lymphoma [NHL].
«We have developed a drug candidate, a next - generation biologic medical product, and are now publishing the fantastic results from the preclinical part where wound healing was strongly accelerated in mice,» says Mia Phillipson, Professor at the Department of Medical Cell Biology, Division of Integrative Physiology, Uppsala University.
Non-exclusive licenses are available for research and sale of products and services across multiple fields including: research tools, kits, reagents; discovery of novel targets for therapeutic intervention; cell lines for discovery and screening of novel drug candidates; GMP production of healthcare products; production of industrial materials such as enzymes, biofuels and chemicals; and synthetic biology.
The PEC - Encap ™ (also known as VC - 01) product candidate is designed to deliver the same pancreatic progenitor cells in an immunoprotective device and is currently in active development as a therapy for all patients with type 1 diabetes as well as insulin requiring patients with type 2 disease.
ViaCyte's PEC - Encap ™ (also known as VC - 01) product candidate delivers the same cell therapy as PEC - Direct but uses a proprietary device called the Encaptra ® Cell Delivery System that is designed to protect the cells from the patient's immune syscell therapy as PEC - Direct but uses a proprietary device called the Encaptra ® Cell Delivery System that is designed to protect the cells from the patient's immune sysCell Delivery System that is designed to protect the cells from the patient's immune system.
ViaCyte is conducting a Phase 1/2 clinical trial of the Company's lead product candidate VC - 01 in patients with type 1 diabetes who have minimal to no insulin - producing beta cell function.
The PEC - Direct ™ product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have severe hypoglycemic episodes, extreme glycemic lability, and / or impaired awareness of hypoglycemia.
ViaCyte's PEC - EncapTM (also known as VC - 01TM) product candidate is the first pluripotent stem cell - derived islet cell replacement therapy for the treatment of type 1 diabetes in clinical - stage development.
In addition, the funding will be used to support other operations including the continued development of the PEC - Encap ™ product candidate, ViaCyte's stem cell - derived islet replacement therapy that is being developed as a treatment for all diabetes patients who require insulin to control their disease.
The first - in - human STEP ONE * trial is evaluating the safety and efficacy of ViaCyte's PEC - Encap (a.k.a. VC - 01 ™) product candidate, a stem cell - derived, encapsulated cell replacement therapy.
San Diego, January 8, 2015 — ViaCyte, Inc., a privately - held regenerative medicine company with the first stem cell - derived islet replacement therapy for the treatment of diabetes in clinical trials, has received a No Objection Letter from Health Canada providing clearance to proceed with sites in Canada for the Company's Phase 1/2 clinical trial of its VC - 01TM product candidate.
ViaCyte's VC - 01 ™ product candidate, a first - in - class cell replacement therapy for the treatment of type 1 diabetes, is currently being evaluated in a Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type One Diproduct candidate, a first - in - class cell replacement therapy for the treatment of type 1 diabetes, is currently being evaluated in a Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type One DiProduct in Type One Diabetes.
Our product candidates are also intended to combine with other mechanisms of action across the oncology landscape, such as checkpoint inhibitors or engineered T cells, to increase the benefit to patients and potentially place Immune Design at a central place in the treatment paradigm.
In 2017, ViaCyte, Inc. announced the allowance of clinical testing for its PEC - Direct cell replacement product candidate for high - risk type 1 diabetes.
The VC - 01 product candidate is currently being evaluated in patients with type 1 diabetes who have minimal to no insulin - producing beta cell function.
Following the acceptance of its IND, ViaCyte initiated a Phase 1/2 clinical trial evaluating the VC - 01 product candidate directly in patients with type 1 diabetes who have minimal to no insulin - producing beta cell function.
The PEC - Direct product candidate delivers stem cell - derived PEC - 01 pancreatic progenitor cells in a device designed to allow direct vascularization of the cells, and is being developed for type 1 diabetes patients that have severe hypoglycemic episodes, extreme glycemic lability, and / or impaired awareness of hypoglycemia.
The PEC - Encap (also known as VC - 01) product candidate is designed to deliver stem cell - derived islet replacement therapies to patients with type 1 diabetes as well as patients with type 2 disease that require insulin.
ViaCyte has two product candidates in human clinical trials using pancreatic progenitor cells.
The PEC - EnCap (formerly VC - 01 ™) product candidate delivers pancreatic progenitor cells in the Encaptra ® immunoprotective device, and is currently being evaluated in a Phase 1/2 trial in patients with type 1 diabetes who have minimal to no insulin - producing beta cell function.
The Company's pluripotent stem cell - derived islet cell replacement therapy, the PEC - Direct ™ product candidate, has the potential to be a breakthrough treatment for high - risk type 1 diabetes.
ViaCyte's product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in a durable and retrievable cell delivery device.
San Diego, August 1, 2017 — ViaCyte, Inc., a privately - held, leading regenerative medicine company, announced today that the first patients have been implanted with the PEC - Direct ™ product candidate, a novel islet cell replacement therapy in development as a functional cure for patients with type 1 diabetes who are at high risk for acute life - threatening complications.
ViaCyte's product candidates are based on the derivation of pancreatic progenitor cells, which are then implanted in a durable and retrievable encapsulation device.
PEC - Direct product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients that have severe hypoglycemic episodes, extreme glycemic lability, and / or impaired awareness of hypoglycemia.
The company seeks to become an industry leader in the neural stem cell field with multiple therapeutic product candidates.
Now, ViaCyte is testing the VC - 01 ™ product candidate made up of macro-encapsulated pancreatic progenitor cells, precursor cells that are expected to differentiate into mature cells that produce insulin and other hormones.
The Company's lead product candidate, VC - 01, is based on the production of pancreatic progenitors derived from human pluripotent stem cells.
The VC - 01 product candidate is the first embryonic stem cell - derived islet replacement therapy to reach clinical testing and is currently being evaluated in patients with T1D who have minimal to no insulin - producing beta cell function.
ViaCyte is conducting a Phase 1/2 clinical trial, called STEP ONE, of the Company's lead product candidate VC - 01 in patients with T1D who have minimal to no insulin - producing beta cell function.
Leveraging the unique insights of its founders and an internal team of outstanding scientists, the Company seeks to become an industry leader in the neural stem cell field with multiple therapeutic product candidates ranging from epilepsy and neuropathic pain to other potential opportunities in the broader neurodegenerative and neuropsychiatric disease space.
The PEC - EnCap (formerly VC - 01 ™) product candidate delivers pancreatic progenitor cells in an immunoprotective device and is currently being evaluated in a Phase 1/2 trial in patients with type 1 diabetes who have minimal to no insulin - producing beta cell function.
The company's antibody - based product candidates target a number of potential indications including AL and AA forms of amyloidosis, Parkinson's disease and other related synucleinopathies and novel cell adhesion targets involved in inflammatory diseases and cancers.
Its product candidate, ELAD System, is a human cell - based bio-artificial liver support system that operates outside the body or extracorporeal.
VXGN has other potentially valuable assets, including a «a state - of - the - art biopharmaceutical manufacturing facility with a 1,000 - liter bioreactor that can be used to make cell culture or microbial biologic products» and rights to specified percentages of future net sales relating to its anthrax vaccine product candidate and related technology.
VXGN has other potentially valuable assets, including a «state - of - the - art biopharmaceutical manufacturing facility with a 1,000 - liter bioreactor that can be used to make cell culture or microbial biologic products» and rights to specified percentages of future net sales relating to its anthrax vaccine product candidate and related technology.