0 Table 3--IR latex compounds continued, dry phr Ingredient IR4 IR5 IR6 IR7 Isolex
Baxter is also working to resolve an outstanding warning letter it disclosed last year over the marketing of its Isolex
devised used in cancer therapy, Reuters reported.
The letter referred to Baxter's Isolex
device used in cancer therapy, according to Baxter spokeswoman Mavis Prall.
In terms of product development activities, the company completed enrollment in a Phase II clinical trial using Baxter's proprietary Isolex
technology to select CD34+ adult stem cells from patients with chronic myocardial ischemia re-infusion into their hearts as a means to restore blood flow.
Screening of patients to complete enrollment in a Phase II trial using Baxter's proprietary Isolex
technology to select CD34+ adult stem cells to improve symptoms and clinical outcomes in patients with chronic myocardial ischemia, a severe form of coronary artery disease.
In his ruling, Harold Varmus, MD, Director of the NIH, wrote, "NIH concludes that Hopkins and Baxter have taken effective steps to achieve practical application, as demonstrated by Hopkins' licensing, Baxter's manufacture, practice and operation of the Isolex
300, and the device's availability to and use by the public.
We're pleased that our ISOLEX
cell selection system is contributing to this area of research," Riedel continued.
The chronic granulonmatous disease program is developing a proprietary cellular therapy, utilizing the Isolex
300I Magnetic Cell Selection System, to produce a stem cell transplant to treat a rare, life-threatening inherited blood disorder.
Baxter's cellular therapy products included in the agreement are the Isolex
300i Magnetic Cell Selection System v2.
Irvine, CA, announced the Therapeutic Products Program of Health Canada ahs issued a medical device license to the company for the sale of the Isolex
300 and Isolex
300I cell selection systems.
300 Cell Separator System, licensed by Nexell Therapeutics, Irvine, CA, is in widespread use in clinical trials in the US and is currently under review by the FDA.
In the third quarter of 1999, product approvals by the Food and Drug Administration (FDA) included Dusa Pharmaceuticals'(DUSA) Levulan Photodynamic Therapy for the treatment of multiple actinic keratoses of the face and scalp; Nexell Therapeutics'(NEXL) Isolex
300 and 300i for removing tumor cells and selecting hematopoetic stems cells after chemotherapy; and Integra's(IART) Duragen, used for restoration of the dural membrane after brain surgery or trauma.