Cytogel is a clinical stage bio-pharmaceutical development company focused on the discovery and development of novel analgesics for the safer treatment of moderate to severe, acute and chronic pain. Our co-founders were dedicated to developing and bringing to market innovative treatments that would provide significantly improved patient outcomes, based on the belief that this objective would require a novel mechanism of action to effectively resolve pain with substantially reduced side effects. Their goal was to develop a molecule that could achieve “opioid-like efficacy” and “non-opioid-like safety”.
Company Background and History
Morphine, which was introduced over 200 years ago, and the other opioids remain a mainstay in modern medicine for treating moderate to severe pain because they are generally more effective than other classes of analgesics. However, they produce euphoria, which can lead to addiction and they slow breathing, which can be fatal. The challenge was finding a solution that could achieve both ends of the spectrum – efficacy that would be comparable to morphine but safety comparable to non-opioid analgesics. With the help of Dr. Gavril Pasternak, and his long-standing research on the opioid receptors, Cytogel discovered that the endomorphin class of peptides preferentially bind to the 6 trans-membrane, truncated form of the mu-opioid receptor, the Exon 11 receptor. Dr. Pasternak’s research elucidated the characteristics of activation of the Exon 11 form of the mu-receptor, being that it produced powerful analgesia but avoided the serious side effects typically produced by activating the 7 trans-membrane form of the mu-receptor, Exon 1, as morphine does. These ground-breaking findings have formed the basis for the development of analogs of endomorphin 1.
A Transformative Compound
The endomorphins are endogenous peptides that are naturally produced by the human brain and are not structurally related to opium or the classical opioids. They cannot be converted to drugs of abuse. CYT-1010® is a tetra-peptide and is an analog of endomorphin 1, the first from this family of molecules to reach clinical development. CYT-1010 possesses a novel mechanism of action, preferentially activating the Exon 11 form of the mu receptors to block pain, while avoiding some of the serious side effects of the current opioid products.
Cytogel has obtained several patents on CYT-1010 around the world, including many composition-of-matter patents. In addition to CYT-1010, many alternative endomorphin-like structures, with interesting characteristics, are included in our portfolio of patents. These molecules represent an array of opportunities that may offer important therapeutic advantages.
CYT-1010 is cleared to enter Phase 2 clinical development as an intravenous agent for acute pain treatment. Cytogel has initiated its next round of financing to raise capital to fund this research. The discovery of the endomorphins offers multiple possibilities for safe and effective pain management for the benefit of patients and medical practitioners together.
This material does not constitute an offer to sell, nor is it a solicitation to buy, any securities. Securities may be offered only to accredited investors through the use of a Confidential Private Placement Memorandum which contains information relevant to the risks and/or merits attendant to any proposed investment, which information is not contained here. Prospective investors shall solely rely upon the Private Placement Memorandum in making investment decisions and not on these materials. No assurance can be made that the Company’s objectives will be achieved or that losses will be avoided. Past performance is not necessarily indicative of future results.
The information in this Presentation is the opinion of Cytogel Pharma, LLC and its advisors based on the results of early stage preclinical and Phase I studies. However, while we believe that these interpretations are reliable and scientifically sound, our ability to successfully develop CYT-1010 into a marketable pharmaceutical product will depend on further development and the results of clinical and scientific studies that have not yet been conducted.
There is no guarantee that the development will produce the necessary results. The FDA could impose a clinical hold on CYT-1010 and block further development. Historically, the percentage of technologies that ultimately fail to achieve marketing approval from the FDA is very high and any investment in such technologies, including CYT-1010, is very risky. Any investment in the Company should be considered in light of these risks. Any financial forecasts included in this presentation are based on opinion and on future favorable events which may never materialize and, as such, should be considered speculative and possibly unachievable.
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