Company Ends Year with an Advancing Full Pipeline and a Catalyst Rich Year Ahead
NEW YORK, Dec. 21, 2017 /PRNewswire/ — Q BioMed Inc. (OTCQB: QBIO), a biotechnology acceleration company, is pleased to provide this year end update to its shareholders.
The Company ends 2017 with a full pipeline of assets advancing towards major milestones in 2018. The Company also ends the year with a clean balance sheet, having settled all outstanding debt and is poised for a very productive a catalyst-rich year in 2018.
We are pleased to provide a summary and an update on our pipeline assets below.
Strontium Chloride 89 Injection USP (Strontium-89)
Strontium-89 is a U.S. Food and Drug Administration approved drug for pain palliation in bone metastases, primarily from breast, prostate and lung cancers. Our product is the only FDA approved generic version of this radiopharmaceutical and is reimbursable by Medicare and private insurers. Strontium 89 is a pure beta emitting radiopharmaceutical. It is a chemical analog of calcium and for this reason, localizes in bone. There is a significant concentration at the site of active osteoblastic activity. This is the biochemical basis for its use in treating metastatic bone disease.
Strontium-89 shows prolonged retention in metastatic bone lesions with a biological half-life of 50 days, remaining up to 100 days after injection. Strontium-89 has been shown to decrease pain in patients with metastases. When Strontium-89 Chloride is used, pain palliation occurs in up to 80% of patients within 2 to 3 weeks after administration and lasts from 3 to 12 months, on average of about 6 months.
In the United States, of the estimated 450,000 individuals newly diagnosed with either breast or prostate cancer, one in three will develop bone metastases, a common cause of pain. These figures are expected to increase as the patient population ages.
Strontium-89 is a non-narcotic (non-opioid) cost effective means for the clinical management of debilitating cancer bone pain. There is a significant opportunity to market Strontium-89 as practitioners and caregivers are being encouraged to reexamine the use of opiates for treating patients in pain. The pain palliation market is estimated to be approximately $300 million annually. Clinical studies at leading medical centers around the world have demonstrated that patient survivals may be extended using Strontium-89 in combination with other agents. Additional therapeutic indications for Strontium 89 are possible, and we intend to pursue this objective in 2018.
We have experienced some delay in launching this drug due to the 2 major hurricanes impacting both of our manufacturing and logistical operations in Texas and Florida, but expect to have a new facility online for manufacturing by mid-January 2018 and pending FDA facility review, commercial sales shortly thereafter. This is expected to be major milestone as we ramp up commercial operations and head into the new year with near-term and long-term recurring revenues as well as the prospect of a significant market opportunity in broader therapeutic indications.
QBM 001 - Addressing a Rare Pediatric Non-verbal Spectrum Disorder
Causes of non-verbal learning disorder have been linked to several complications that range from a specific mutated gene as with Fragile X Syndrome and Dravet Syndrome or autoimmunity, in which the body’s immune system attacks parts of the brain. Trauma, microbial infections and environmental factors have also been linked to non-verbal learning disorder. Ongoing research is helping to further explain the root cause of why children become non-verbal or minimally verbal.
Children born into families where there is a genetic history of autism or epileptic spectrum disorders or that have a sibling that has been diagnosed with an autistic or epileptic spectrum disorder have a much higher chance of becoming non-verbal.
More than 60,000 US children develop Autism Spectrum Disorders (“ASD”) every year, of whom 20,000 become non-verbal. A similar number of children with ASD symptoms in Europe develop pediatric non-verbal disorder each year. No drugs are currently available to ameliorate this condition. In the United States, of the estimated 20,000 who become non- or minimally verbal and will require assisted living for the rest of their life. The lifetime cost of that care is estimated at $10 million per person.
Cognitive intervention is the only form of treatment that has shown to improve speech capability and social interaction; however, it has not been able to alleviate the lifetime burden of $10 million per person for cost of care. This is compounded by an additional $10 million during the lifespan of the person due to loss in productivity in addition to severe emotional strain for the child and the parents.
In light of the above, we are developing QBM-001 to be administered to a high-risk, target group of toddlers of 3 years or younger. We can identify these toddlers by blood markers, EEG testing and whole genome sequencing. A commonality that these toddlers share is faulty membrane channels, which was elucidated from retrospective genetic studies of nonverbal individuals. Faulty membrane channels can lead to many detrimental effects. We believe that QBM-001 acts as an allosteric regulator of these faulty channels in the brain to potentially alleviate the condition and allow toddlers to actively develop language and speech and avoid life-long speech and intellectual disability of being non-verbal.
As there are no treatment options for these patients, we believe there is a significant economic opportunity to bring a drug to market in this indication. The active ingredient in QBM-001 is well known and has been approved by worldwide regulators for many years. Q BioMed produced an analog of the parent molecule that serves multiple purposes. One, it eliminates gastrointestinal problems of the parent molecule. Two, it allows for a more time-release of product and it provides a load capacity, which is designed to prevent over-administration. Three, the aforementioned characteristics of QBM-001 then allow for more sustained levels of product in the body over time which is ideal for a condition that requires long-term, prophylactic use. Due to the unique composition of the analog and the known safety and efficacy of the parent molecule, we intend to advance this drug through the 505(b)(2) pathway in a single phase 2/3 clinical trial that we intend to commence in 2018.
We have made great progress in assembling our technical team and in the development of the final drug analogue which is now finishing pre-clinical testing. Once complete in Q1 2018, we expect to file an IND and initiate a pivotal clinical trial. We have already met with several potential clinical sites, both in the US and Europe and all look forward to collaborating on this pioneering study. Given the potential for an accelerated clinical trial pathway, we see this as a very significant catalyst in 2018 which could yield interim phase 2 data prior to the end of the year.
UTTROSIDE-B - A New Chemotherapeutic for Liver Cancer
The only currently marketed drug for liver cancer is a tryosine kinase inhibitor antineoplastic agent, Sorafinib. Uttroside-B appears to affect phosphorylated JNK (pro survival signaling) and capcase activity (apoptosis in liver cancer). It is a natural compound fractionated Saponin derived from the Solarim Nigrum plant. It is a small molecule that showed in early investigation to increase the cytotoxicity of a variety of liver cancer cell types and importantly to be up to ten times more potent than Sorafenib in pre-clinical studies. This potency motivated us to work with our partners to chemically synthesize the plant based molecule. Synthesis has progressed well in 2017, and we expect to have the final analogue ready for testing in Q1 2018. Once validated, we will prepare and submit an IND for a Phase one clinical trial to begin in late 2018.
MAN 01 - A Platform Technology with an Initial Focus on Glaucoma
We are developing MAN 01 as a first-in-class therapeutic eye-drop for the treatment of Primary Open Angle Glaucoma.
MAN 01 targets the Schlemm’s canal and its role in regulating interocular eye pressure, one of the leading causes of glaucoma. No other glaucoma company is targeting the Schlemm’s canal, the main drainage pathway in the eye. This unique vessel is responsible for 70-90% of the fluid drainage in the eye.
We believe that a deep pipeline of novel therapeutics can be developed from this research platform, which would treat a spectrum of vascular diseases including cystic kidney disease, pediatric glaucoma and inflammation.
We are completing development work on optimal delivery and absorption of a small molecule delivered topically to treat patients with Primary Open Angle Glaucoma. We anticipate completing pre-clinical proof-of-concept development in 2018 and expect to initiate a clinical trial program in 2019.
We have made great progress in our short history and we look forward to another exciting and eventful year in 2018. Stay up to date and follow our progress by joining our mailing list at www.qbiomed.com.
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: 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.
Q BioMed Inc.
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