Study to Evaluate Fulvestrant Administered With Atossa’s Patented Intraductal Microcatheters; Atossa Now Has Two Phase II Clinical Programs
SEATTLE, WA, USA I September 21, 2015 I Atossa Genetics Inc. (NASDAQ: ATOS), a healthcare company focused on improving breast health through the development of pharmaceuticals to treat breast health conditions and through commercialization of medical devices and laboratory tests, today announced that the U.S. Food and Drug Administration has accepted the Company’s Investigational New Drug (IND) application for a clinical trial of Fulvestrant in patients with Ductal Carcinoma in Situ (DCIS) or breast cancer.
Acceptance of the IND by the FDA enables Atossa to now move forward with an open-label, non-randomized pharmacokinetic and safety study of Fulvestrant in women with DCIS or breast cancer who are scheduled for mastectomy. Patients will be treated with either intramuscular Fulvestrant or intraductal instillation of Fulvestrant utilizing Atossa’s patented intraductal microcatheter device. Atossa is the owner of an issued patent and several pending applications directed to the treatment of breast conditions, including cancer, by intraductal administration of Fulvestrant. Additional information about the study can be found at: https://clinicaltrials.gov/ct2/show/NCT02540330?term=atossa&rank=2
Sheldon M. Feldman, M.D., of the Columbia University Medical Center Breast Cancer Program is expected to be the principal investigator. The trial is scheduled to commence in December 2015.
“The FDA’s acceptance of our Fulvestrant IND is a significant milestone for Atossa that hallmarks a potentially new, locally administered treatment for DCIS via intraductal administration utilizing our patented microcatheters,” said Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics.” DCIS is a serious medical condition diagnosed in approximately 60,000 women a year in the U.S. The current standard of care for these women includes surgical removal of the tumor, radiation, and/or Tamoxifen treatment and in some cases mastectomy. Together with our Afimoxifene Gel, we now have two Phase II programs underway,” he continued.
SOURCE: Atossa Genetics
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Study to Evaluate Fulvestrant Administered With Atossa’s Patented Intraductal Microcatheters; Atossa Now Has Two Phase II Clinical Programs
SEATTLE, WA, USA I September 21, 2015 I Atossa Genetics Inc. (NASDAQ: ATOS), a healthcare company focused on improving breast health through the development of pharmaceuticals to treat breast health conditions and through commercialization of medical devices and laboratory tests, today announced that the U.S. Food and Drug Administration has accepted the Company’s Investigational New Drug (IND) application for a clinical trial of Fulvestrant in patients with Ductal Carcinoma in Situ (DCIS) or breast cancer.
Acceptance of the IND by the FDA enables Atossa to now move forward with an open-label, non-randomized pharmacokinetic and safety study of Fulvestrant in women with DCIS or breast cancer who are scheduled for mastectomy. Patients will be treated with either intramuscular Fulvestrant or intraductal instillation of Fulvestrant utilizing Atossa’s patented intraductal microcatheter device. Atossa is the owner of an issued patent and several pending applications directed to the treatment of breast conditions, including cancer, by intraductal administration of Fulvestrant. Additional information about the study can be found at: https://clinicaltrials.gov/ct2/show/NCT02540330?term=atossa&rank=2
Sheldon M. Feldman, M.D., of the Columbia University Medical Center Breast Cancer Program is expected to be the principal investigator. The trial is scheduled to commence in December 2015.
“The FDA’s acceptance of our Fulvestrant IND is a significant milestone for Atossa that hallmarks a potentially new, locally administered treatment for DCIS via intraductal administration utilizing our patented microcatheters,” said Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics.” DCIS is a serious medical condition diagnosed in approximately 60,000 women a year in the U.S. The current standard of care for these women includes surgical removal of the tumor, radiation, and/or Tamoxifen treatment and in some cases mastectomy. Together with our Afimoxifene Gel, we now have two Phase II programs underway,” he continued.
SOURCE: Atossa Genetics
Post Views: 237
