Q Biomed Inc. Announces FDA Filing for Approval of a New Manufacturing Facility for Non-Opioid Strontium Chloride SR89 Injection USP for Relief of Cancer Bone Pain
NEW YORK, March 16, 2018 /PRNewswire/ --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.
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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.
Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: inspection of the proposed third-party manufacturing facility by the FDA or other comments or requests from the FDA in connection with the above mentioned regulatory filing; failure of the proposed third-party manufacturing facility to pass an inspection by the FDA; regulatory risks; risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Contact Denis Corin CEO Q BioMed Inc. +1-888-357-2435
SOURCE Q BioMed Inc.