NEW YORK, NY, USA I March 16, 2018 I Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotechnology acceleration development company, and Bio-Nucleonics, licensor of Strontium 89 Chloride, announce submission of a regulatory filing to the FDA for the approval of a new manufacturing facility. Upon approval by the FDA, the facility will be permitted to manufacture Strontium Chloride Sr89 Injection USP (Strontium-89) in accordance with cGMP.
Strontium-89 is a non-opioid injectable radiopharmaceutical to relieve cancer bone pain in patients with painful skeletal metastases. In the body, strontium acts similar to calcium, selectively localizing in bone and is preferentially taken up in osteoblastic lesions. The unabsorbed isotope clears rapidly from the blood and is excreted in the urine the first 2 to 3 days following injection. Uptake of Strontium-89 occurs preferentially in sites of active osteogenesis; thus bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of Strontium-89 than surrounding normal bone.
Strontium-89 is a pure beta emitter, and selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from bone lesions. The presence of bone metastases should be confirmed prior to therapy. When blastic osseous metastases are present, significantly enhanced localization of the radiopharmaceutical will occur with corresponding higher doses to the metastases compared with normal bones and other organs. Although responses can vary, pain relief typically begins 7 to 20 days after injection and lasts for four months or more.
Please visit www.strontium89.com for more information
About Q BioMed Inc.
Q BioMed, Inc. is a biomedical acceleration and development company. We are focused on licensing and acquiring biomedical assets across the healthcare spectrum. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support and expansion capital they need to meet their developmental potential so that they can provide products to patients in need
Please visit www.qbiomed.com and sign up to receive regular updates. Follow us on social media @QBioMed.
About Strontium Chloride Sr89 Injection USP
INDICATIONS AND USAGE: Strontium Chloride Sr-89 Injection USP, is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy.
CONTRAINDICATIONS: None known.
WARNINGS: Use of Strontium Chloride Sr89 Injection USP in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium Chloride Sr89 Injection USP, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient’s peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium Chloride Sr89 Injection USP. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient’s disease or additional therapy intervenes. In considering repeat administration of Strontium Chloride Sr89 Injection USP, the patient’s hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully evaluated. Verification of dose and patient identification is necessary prior to administration because Strontium Chloride Sr89 Injection USP delivers a relatively high dose of radioactivity.
SOURCE: Q BioMed
Post Views: 21
NEW YORK, NY, USA I March 16, 2018 I Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotechnology acceleration development company, and Bio-Nucleonics, licensor of Strontium 89 Chloride, announce submission of a regulatory filing to the FDA for the approval of a new manufacturing facility. Upon approval by the FDA, the facility will be permitted to manufacture Strontium Chloride Sr89 Injection USP (Strontium-89) in accordance with cGMP.
Strontium-89 is a non-opioid injectable radiopharmaceutical to relieve cancer bone pain in patients with painful skeletal metastases. In the body, strontium acts similar to calcium, selectively localizing in bone and is preferentially taken up in osteoblastic lesions. The unabsorbed isotope clears rapidly from the blood and is excreted in the urine the first 2 to 3 days following injection. Uptake of Strontium-89 occurs preferentially in sites of active osteogenesis; thus bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of Strontium-89 than surrounding normal bone.
Strontium-89 is a pure beta emitter, and selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from bone lesions. The presence of bone metastases should be confirmed prior to therapy. When blastic osseous metastases are present, significantly enhanced localization of the radiopharmaceutical will occur with corresponding higher doses to the metastases compared with normal bones and other organs. Although responses can vary, pain relief typically begins 7 to 20 days after injection and lasts for four months or more.
Please visit www.strontium89.com for more information
About Q BioMed Inc.
Q BioMed, Inc. is a biomedical acceleration and development company. We are focused on licensing and acquiring biomedical assets across the healthcare spectrum. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support and expansion capital they need to meet their developmental potential so that they can provide products to patients in need
Please visit www.qbiomed.com and sign up to receive regular updates. Follow us on social media @QBioMed.
About Strontium Chloride Sr89 Injection USP
INDICATIONS AND USAGE: Strontium Chloride Sr-89 Injection USP, is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy.
CONTRAINDICATIONS: None known.
WARNINGS: Use of Strontium Chloride Sr89 Injection USP in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium Chloride Sr89 Injection USP, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient’s peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium Chloride Sr89 Injection USP. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient’s disease or additional therapy intervenes. In considering repeat administration of Strontium Chloride Sr89 Injection USP, the patient’s hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully evaluated. Verification of dose and patient identification is necessary prior to administration because Strontium Chloride Sr89 Injection USP delivers a relatively high dose of radioactivity.
SOURCE: Q BioMed
Post Views: 21
