NEW YORK, Feb. 14, 2020 /PRNewswire/ -- Spherix Incorporated (NASDAQ: SPEX), a technology development company committed to the fostering of innovative ideas, today issued a letter to shareholders:
Dear Fellow Shareholder,
One of the most important responsibilities of a public company CEO is a commitment to frequent and clear communication with shareholders. Over the last few years, our shareholders have supported management's efforts to transform our company from a deeply researched series of ideas on scientific approaches towards oncology to a tangible set of assets and opportunities.
With our newly acquired oncology assets, we expect to transform Spherix into an innovative pharmaceutical company dedicated to translating fundamental biological insights into new drugs and treatments that address unmet medical needs. Moving forward, we are committed to providing our shareholders with substantive information on these pioneering treatments, starting with our pancreatic cancer drug, DHA-dFdC.
Developed at the University of Texas at Austin, DHA-dFdC is a new compound that we believe would become the next generation of second-line chemotherapy treatment for advanced pancreatic cancer. According to the Hirshberg Foundation for Pancreatic Cancer Research, pancreatic cancer is the 3rd leading cause of cancer-related deaths in the United States, surpassing breast cancer. It is expected to become the 2nd leading cause of cancer-related deaths in the United States by the year 2020, surpassing colorectal cancer. Pancreatic cancer also has the highest mortality rate of all major cancers, 91% of pancreatic cancer patients will die within five years of diagnosis, only 8% will survive more than five years and 74% of patients die within the first year of diagnosis. Sadly, pancreatic cancer is one of the few cancers for which survival has not improved substantially in over 40 years.
Preclinical data shows that DHA-dFdC overcomes tumor cell resistance to current chemotherapeutic drugs and is well tolerated in preclinical toxicity tests. The studies have also indicated that DHA-dFdC has documented efficacy against pancreatic tumors in a clinically relevant transgenic mouse model, inhibiting pancreatic cancer cell growth (up to 100,000-fold more potent that gemcitabine, a current standard therapy; i.e., the IC50 value of DHA-dFdC is more than 100,000-fold smaller than gemcitabine), and has demonstrated activities against other cancers, including leukemia, lung and melanoma.
The science behind Gem-DHA has thus far been published in three peer reviewed scientific journals:
- Naguib et al. (2016) Synthesis, characterization, and in vitro and in vivo evaluations of 4-(N)-docosahexaenoyl 2 ́, 2 ́- difluorodeoxycytidine with potent and broad-spectrum antitumor activity, NeoPlasia 18: 33-48.
- Valdes et al. (2017) Preclinical evaluation of the short-term toxicity of 4-(N)-docosahexaenoyl 2 ́, 2 ́- difluorodeoxycytidine (DHA-dFdC), Pharm. Res. 34: 1224-1232.
- Valdes et al. (2019) A solid lipid nanoparticle formulation of 4-(N)-docosahexaenoyl 2 ́, 2 ́- difluorodeoxycytidine with increased solubility, stability, and antitumor activity, Int. J. Pharm. 570:118609
According to the published data, the drug:
- Unexpectedly concentrates itself in the pancreas relative to other organs.
- Significantly increases the lifespan of mice with pancreatic cancer in either mice predisposed to develop the cancer, or into which human pancreatic cancer has been injected.
- Significantly decreases the growth of pancreatic tumors in mice, better than gemcitabine, the current standard of care.
- Has a novel lipid nanoparticle oral formulation that significantly delays tumor growth and is well tolerated in mice.
The United States Patent Office recently issued the first patent covering DHA-dFdC in November 2019. All of this technology has been licensed to Spherix for commercial development and we could not be more enthusiastic about the potential to both meaningfully help patients and reward shareholders.
The road to commercialization of any drug is never linear or effortless. A collection of oncology assets as important as ours demands that the cadence of our process is conducted with the most qualified of teams and service providers. To that end we will seek to bring the most capable and knowledgeable people in the oncology field into the fold as we set upon our goal of taking these compounds to market. We look forward to keeping our shareholders apprised of our significant milestones as well as any potential setbacks along the way.
Chief Executive Officer
Spherix Incorporated, a Delaware corporation (the "Company"), was initially formed in 1967 and is currently a biotechnology company with a diverse portfolio of small-molecule anti-cancer therapeutics. The Company's platform consists of patented technology from leading universities and researchers and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and Wake Forest University. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). In addition, we are constantly seeking to grow our pipe to treat unmet medical needs in oncology
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company's filings with the SEC, not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Brett Maas, Managing Partner
Phone: (646) 536-7331
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