LONDON (ShareCast) - ReNeuron has reported further progress in the clinical trial of its ReN001 stem cell therapy for disabled stroke patients, known as the PISCES study. The third and penultimate batch of three patients have all been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising. This follows approval last month by the independent Data Safety Monitoring Board (DSMB) for the study to proceed to completion of dosing of this batch of patients. The PISCES study continues to run to plan, with no cell-related serious adverse events reported in any of the patients treated to date, the clinical-stage stem cell specialist reported. The remaining three, high-dose cohort patients to be treated in the PISCES study have been identified and evaluated as potentially eligible for treatment, with patient enquiries continuing to come into the Glasgow clinical site and a number of patients consequently identified as reserve candidates for the study. Subject to DSMB approval, these final three patients are scheduled to be treated in January and March 2013. In June of this year, interim data from the PISCES study from the first five patients treated was presented by the Glasgow clinical team at the 10th … Continue reading →

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug. In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA. "Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday. The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests. The new warning letter reiterates those problems and asks for more information about them. David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA. In a … Continue reading →

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug. In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA. "Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday. The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests. The new warning letter reiterates those problems and asks for more information about them. David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA. In a … Continue reading →

COLLIER COUNTY - A Southwest Florida doctor spent another day in court fighting for his right to practice medicine. Bonita Springs cardiologist Zannos Grekos' license is currently suspended because two of his patients died after undergoing a controversial stem cell procedure. Wednesday was day two of what's scheduled to be a four day trial. The courtroom was again filled with patients supporting Grekos and his stem cell treatment. This hearing focuses only on the first patient that died after getting that treatment. Her family was also in attendance and wants Grekos' medical license revoked. Dr. Richard Roland spoke about a call he got from Grekos in 2010. He had just performed a stem cell procedure on his patient Domenica Fitgzerald and something went wrong. Roland was Fitzgerald's ICU doctor. "I was quite shocked. My first comment was, 'You did what?' His response was, 'Yes. We've been having good luck with these procedures,'" Dr. Roland said. "I had concerns that this was criminal." Fitzgerald's family says the breast cancer survivor was looking for a cure for nerve damage caused by chemotherapy. They say Grekos gave her false hope. More here: Stem cell doctor in court: Day 2 … Continue reading →

StemCells Inc. has a history not much different from those of dozens, even hundreds, of biotech companies all around California. Co-founded by an eminent Stanford research scientist, the Newark, Calif., firm has struggled financially while trying to push its stem cell products through the research-and-development pipeline. It collects about $1 million a year from licensing patents and selling cell cultures but spends well more than $20 million annually on R&D, so it runs deeply in the red. On the plus side, StemCells Inc. has had rather a charmed relationship with the California stem cell program, that $3-billion taxpayer-backed research fund known formally as the California Institute for Regenerative Medicine. The firm ranks first among all corporate recipients of approved funding from CIRM, with some $40 million in awards approved this year. That's more than has gone to such established California nonprofit research centers as Cedars-Sinai Medical Center, the Salk Institute for Biological Studies, and the Sanford-Burnham Medical Research Institute. The record of StemCells is particularly impressive given that one of the two proposals for which the firm received a $20-million funding award, covering a possible Alzheimer's treatment, was actually rejected by CIRM's scientific review panel twice. Nevertheless, the stem cell … Continue reading →