Stem Cell Therapeutics Receives U.S. Orphan Drug Designation
News Nov 01, 2013
Stem Cell Therapeutics Corp. has announced that it has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the use of tigecycline in the treatment of acute myeloid leukemia (AML).
Orphan Drug designation is granted to therapeutics treating rare diseases affecting less than 200,000 people in the U.S. The designation entitles the sponsor to seven years of market exclusivity as well as opportunities for additional funding and expert protocol assistance.
“Orphan Drug status significantly enhances the commercial potential of tigecycline in AML, a disease which is notoriously difficult to treat", said the company’s Vice President, Drug Development, Dr. Penka Petrova.
Petrova continued, “Through its unique mechanism of action and synergy with existing AML therapies, tigecycline has the potential to positively impact the standard of care in this disease”.
The company’s program is based on Dr. Aaron Schimmer’s published findings that tigecycline, an FDA-approved antibiotic, selectively targets leukemia cells and leukemic stem cells by inhibiting mitochondrial protein synthesis and thus shutting down the cells’ energy supply.
A Phase I Canadian and U.S. multicenter dose-escalation clinical trial in patients with relapsed or refractory AML is nearing completion.
“The Orphan Drug designation covers tigecycline as an active ingredient and is independent of the drug formulation,” added Dr. Bob Uger, the company’s Chief Scientific Officer. “We are investigating improved formulations of tigecycline, which we believe will be critical for the commercialization of this technology”.
Possible Biomarker to Identify Who Would Benefit from ImmunotherapyNews
While immunotherapy has made a big impact on cancer treatment, the fact remains that only about a quarter of patients respond to these treatments. In a new study, researchers examined tissue samples from melanoma and ovarian cancer patients treated with immunotherapies and found a link between the percentage of antigen-presenting cells expressing PD-L1 and an objective clinical response to treatment.READ MORE
Fight Against Cancer: Drug Combination Helps Kickstart the Immune SystemNews
Scientists from King's College London have found a way to boost the immune system to help it fight back against cancer.
The breakthrough involves the first ever use of a combination of chemotherapy and a drug being trialled as a treatment for neonatal jaundice, that together help kick start the body's natural defences.
Arrow Poison Potential Male Birth ControlNews
Women have many options for oral contraceptives that are safe, effective and reversible, but despite decades of research, men have none. Now, scientists report a rat study that shows they finally have a good lead for a male birth control pill. It's based on ouabain, a plant extract that African warriors and hunters traditionally used as a heart-stopping poison on their arrows.READ MORE