Specifically, application of a prefabricated cardiac tissue patch to prevent dilation and to improve pumping efficiency of the infarcted heart offers a promising strategy for making stem
cell therapy a clinical reality.
Dear readers, as you know I have been collecting
cell therapy clinical trials data for several years now.
-LSB-...] clinical trials analysis Leeza Rodriguez has joined
our cell therapy clinical trials network.
Not exact matches
Kite Pharma, one of the companies chasing a new generation of cancer drugs called chimeric antigen receptor T -
cell (CAR - T)
therapies, announced a patient death in a
clinical trial of its experimental KTE - C19.
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).
US - based pharmaceutical company Gilead Sciences entered the chimeric antigen receptor (CAR) T -
cell therapy business through its acquisition of Kite Pharma, and Australian biopharma company CSL Behring acquired US - based Calimmune, a company that develops
clinical - stage gene
therapy solutions.
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.
With major
clinical successes in areas such as CAR - T, gene
therapy, immune - oncology,
cell therapy and gene editing, many see 2017 as the year that biotech really came of age.
The truth, of course, is that there are no human embryonic stem -
cell therapies even in
clinical trial, let alone ready for
therapy, and there have been no major treatment....
Based on results of the current study described in a report online June 18 in the journal Cancer
Cell, Johns Hopkins researchers say they are planning a phase I
clinical trial to test the paclitaxel - fostamatinib combination
therapy in patients with recurrent advanced ovarian cancer.
«Current
therapies in
clinical trials are focused on targeting genetic changes in tumors and helping to boost one's immune system to fight the cancer
cells.
«There are currently no
therapies which successfully reverse the damage seen in the more than 12,000 individuals who suffer a spinal cord injury each year in the United States alone,» says Dr. Richard G. Fessler, professor of neurological surgery at Rush University Medical Center and principal investigator for the Phase 1
clinical trial involving AST - OPC1 (oligodendrocyte progenitor
cells).
«Fibroblast growth factor receptor inhibitors are new
therapies being developed in
clinical trials for patients whose cancer
cells have genetic alterations in this family of genes,» says Roychowdhury, a member of the OSUCCC — James Translational Therapeutics Program.
Now a University of Colorado Cancer Center study published online ahead of print in the journal Oncogene offers compelling evidence explaining this failure and offering a possible strategy for the use of retinoic acid or other retinoids against some breast cancers: Because early
clinical trials are often offered to patients who have already tried other more established
therapies, breast cancer
cells may have been pushed past an important tipping point that offers retinoic acid resistance.
He notes his company had planned this year to apply to the U.S. Food and Drug Administration to use red blood
cells and platelets derived from iPS
cells in
clinical trials, but «at this point,
therapies with these
cells are years off.»
«These are optimistic results for one of the first targeted
therapies for cancer stem
cells,» says Antonio Jimeno, MD, PhD, investigator at the CU Cancer Center, director of the university's Cancer Stem
Cell - Directed
Clinical Trials Program, and principal investigator of the clinical trial at the CU Cancer Cent
Clinical Trials Program, and principal investigator of the
clinical trial at the CU Cancer Cent
clinical trial at the CU Cancer Center site.
Although no
clinical trials involving
therapies derived from iPS
cells are on the books, researchers are currently testing drugs on them.
One
clinical trial involves the drug CGF166, a one - time gene
therapy, which, if proven successful in humans, could regenerate new hair
cells within the cochlea that can signal the part of the brain that processes sound.
A U.K. team is designing a
clinical trial even more radical than prenatal stem
cell therapy: the first ever test of gene
therapy in pregnancy.
In the past year, the South Korean Food and Drug Administration (FDA) has approved the world's first three stem -
cell treatments — Hearticellgram - AMI, Cupistem and Cartistem — which followed on the heels of
clinical tests for human embryonic stem -
cell therapies approved in 2010, according to the health ministry.
Priscilla N. Kelly Associate Editor Education: B.Sc., University of Western Australia; Ph.D., University of Melbourne Areas of responsibility: Preclinical development, translational medicine, cancer immunotherapy, drug discovery,
clinical trials, gene and
cell therapy E-Mail:
[email protected]
Muscle biologists Qi Long Lu and Terence Partridge at the Medical Research Council
Clinical Sciences Centre in London, U.K., and their colleagues decided to combined the antisense strategy with a chemical often used in gene
therapy because it is known to improve delivery of DNA into
cells.
The authors of the commentary argue that rigorous
clinical testing and regulation of stem
cell therapies are essential to introduce safe and effective medical interventions for patients.
They may also have implications for current
clinical trials testing stem -
cell - based
therapies for diabetes.
It showed effectiveness against liver cancer in a phase II
clinical trial and will move into a phase III trial later this year, David Kirn, an oncologist and the company's president and chief executive officer, said at a recent meeting of the American Society for Gene &
Cell Therapy in Washington, D.C..
Clinical trials that charge enrollees to participate are ostensibly aimed at giving patients early access to promising
therapies — often in the fields of stem
cells or aging reversal — that are too unusual or have too little profit potential to get funding from traditional sources such as companies, foundations, or the National Institutes of Health.
Combining radiation
therapy with chemotherapy for patients with limited metastatic non-small
cell lung cancer (NSCLC) may curb disease progression dramatically when compared to NSCLC patients who only receive chemotherapy, according to a new randomized phase II
clinical trial reported today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO).
To strengthen its
clinical research profile, Dresden has created a strategic plan, to be funded by the German Research Ministry (BMBF), that focuses on three aspects of
clinical research: tissue engineering and development of physical and molecular medical technologies for
clinical application; therapeutic strategies after
cell and tissue damage; and diagnosis and
therapy of malignant diseases.
The proposed
clinical trial, in which researchers would use CRISPR to engineer immune
cells to fight cancer, won approval from the Recombinant DNA Advisory Committee (RAC) at the U.S. National Institutes of Health, a panel that has traditionally vetted the safety and ethics of gene
therapy trials funded by the U.S. government and others.
«The treatment of multiple myeloma has improved significantly in recent years with the introduction of
therapies such as proteasome inhibitors [which interfere with tumor
cells» protein - disposal system] and potent immuno - modulatory agents,» said the paper's senior author and lead investigator, Paul Richardson, MD,
clinical program leader and director of
clinical research at Dana - Farber's Jerome Lipper Multiple Myeloma Center, and the R.J. Corman professor at Harvard Medical School.
A
clinical trial in the Republic of Korea for patients with degenerative eye diseases is the first to test the safety of an embryonic stem
cell therapy for people of Asian descent.
Graham looked to the Internet for treatment options and came across Duke University oncologist Keith Sullivan, who was comparing standard chemotherapy and stem
cell therapy as part of a large - scale
clinical trial for scleroderma.
One clinician who has not waited for controlled
clinical studies is California osteopath David Steenblock, who offers stem
cell therapy for more than 20 diseases, including Alzheimer's, traumatic brain injury, Parkinson's, arthritis, stroke, and heart disease.
A panel of top science administrators and stem
cell scientists met on Friday with Davide Vannoni, the president of an Italian foundation providing highly controversial stem
cell treatments, in a first effort to hash out the details of a government - sponsored
clinical trial of the
therapy.
The present and potential
clinical applications of mesenchymal stem
cell therapy in cats are explored in a state - of - the - art review article published this month in the Journal of Feline Medicine and Surgery.
Dr. Levine directs the
Clinical Cell and Vaccine Production Facility (CVPF), which develops, manufactures, and tests novel cell and gene therapies in clinical trials at Penn and collaborating insti
Clinical Cell and Vaccine Production Facility (CVPF), which develops, manufactures, and tests novel cell and gene therapies in clinical trials at Penn and collaborating instituti
Cell and Vaccine Production Facility (CVPF), which develops, manufactures, and tests novel
cell and gene therapies in clinical trials at Penn and collaborating instituti
cell and gene
therapies in
clinical trials at Penn and collaborating insti
clinical trials at Penn and collaborating institutions.
«T -
cell receptor
therapy achieves encouraging
clinical responses in multiple myeloma: NY - ESO T
cell receptor
therapy found to be safe, with no cytokine release syndrome cases.»
Results from a
clinical trial investigating a new T
cell receptor (TCR)
therapy that uses a person's own immune system to recognize and destroy cancer
cells demonstrated a
clinical response in 80 percent of multiple myeloma patients with advanced disease after undergoing autologous stem
cell transplants (ASCT).
Clinical trials of nitric oxide
therapy to ease pain in sickle
cell patients have yielded conflicting results, with some patients reporting increased pain.
Three months after the Chinese health ministry ramped up its efforts to enforce a ban on the
clinical use of unapproved stem -
cell treatments, a Nature investigation reveals that businesses around the country are still charging patients thousands of dollars for these unproven
therapies.
Genetically modified «hunter» T
cells successfully migrated to and penetrated a deadly type of brain tumor known as glioblastoma (GBM) in a
clinical trial of the new
therapy, but the
cells triggered an immunosuppressive tumor microenvironment and faced a complex mutational landscape that will need to be overcome to better treat this aggressive cancer, Penn Medicine researchers report in a new study this week in Science Translational Medicine.
And it called for a nationwide moratorium on new
clinical trials for stem -
cell therapies, adding that patients in existing
clinical trials should not be charged.
Several
clinical trials are testing
cell replacement
therapies to treat spinal cord injuries.
Boston Children's Hospital has offered non-exclusive licenses to for - profit entities on a patent developed by Orkin's laboratory regarding BCL11A, a genetic switch regulating hemoglobin production that is expected to form the basis of
clinical trials for gene
therapy and gene editing for sickle
cell disease and thalassemia.
«New way to unmask melanoma
cells to the immune system: Lab studies show promise for a
clinical trial aimed at improving current immune
therapies.»
While neural stem
cell therapies are already advancing to
clinical trials, this research raises cautionary notes about moving to human
therapy too quickly, said Tuszynski.
In 2017, a steady stream of encouraging
clinical results showed progress in gene
therapies for hemophilia, sickle -
cell disease, blindness, several serious
In this way we hope to lay a
clinical groundwork for two new techniques: liver
cell transplantation and liver gene
therapy.»
If these preclinical studies are successful, the researchers plan to further develop their CAR T
cell therapy and test its safety and efficacy for different types of metastatic cancer in upcoming
clinical trials.
In recent
clinical trials, CAR T
cell therapy has dramatically improved the outcomes of blood cancer patients with advanced, otherwise untreatable forms of leukemia and lymphoma.