WHITEFISH, MT / ACCESSWIRE / November 18, 2014 / Cellular signaling is a complex system of communication that governs basic cellular activities and coordinates cell actions. In many cases, errors in cellular information processing are responsible for diseases like cancer, autoimmune disorders, and diabetes. Researchers are attempting to understand these cellular signaling pathways to effectively treat these disorders and accomplish other medical feats.
Lixte Biotechnology Holdings Inc. (OTC: LIXT) is focused on designing compounds to attack key cellular signaling pathways that are altered by these diseases. For example, its LB-100 series inhibits the removal of phosphate groups and its LB-200 series inhibits the removal of acetyl groups. The approach has led to the discovery of novel agents with potential value in treating many disparate diseases.
Cancer Therapies
There are many different approaches to treating cancer, ranging from immunotherapy approaches pioneered by Dendreon Corporation (NASDAQ: DNDN) to monoclonal antibody strategies implemented by companies like Seattle Genetics Inc. (NASDAQ: SGEN). Lixte Biotechnology has taken a new approach to cancer treatment by focusing on these cellular signaling pathways.
In cancerous cells, the ability to rapidly divide without undergoing cellular death ("apoptosis") comes at the cost of back-up systems needed to survive under stress. Normal cells possess all of these regulatory systems and are not as vulnerable to growth inhibition or killing even though important regulatory pathways may be transiently altered by a drug therapy for that explicit purpose.
Lixte Biotechnology's novel approach is to exploit this differential sensitivity to cell killing mechanisms between cancerous cells and normal cells. By taking this approach, the company aims to enhance the effectiveness of current and evolving chemotherapy and radiotherapy regimes for many, if not all, cancers. The therapy's use as an adjunct therapy also affords it broad usage across many diseases.
Early Signs of Success
Lixte Biotechnology's early animal studies targeting protein phosphatase 2A ("PP2A") through its LB-100 series suggest that the treatment can be given intermittently at significant doses with no observable toxicity and daily for five days without encountering limiting toxicity. These data points debunk the previous beliefs that PP2A inhibition would be overly toxic to patients.
Interestingly, the same approach has been tried in the past showing the same types of results. Fostriecin - an antibiotic that naturally inhibited PP2A - was evaluated in Phase I studies sponsored by the National Cancer Institute ("NCI") and showed a similarly strong safety profile. These trials were discontinued, however, due to an inadequate supply of the natural product to justify the costs.
The U.S. Food and Drug Administration approved a Phase I study in patients with advanced cancers given alone and then in combination with docetaxel - a popular anti-cancer drug. This Phase I study is being conducted at the Mayo Clinic in Minnesota and City of Hope National Medical Center in California and is expected to wrap up around June 2015. Once the toxicity profile is established, the company plans to pursue Phase II clinical trials against malignancies for which docetaxel alone is approved for treatment and then evaluate the combination's efficacy.
Blue Sky Potential
Lixte Biotechnology trades with a modest sub-$10 million market capitalization, despite its potential to dramatically improve existing cancer therapies. As the company draws closer to Phase I and Phase II clinical trials, the market's concerns over toxicity could be erased and the potential could be realized to a greater extent, potentially pushing up the stock's overall valuation.
While the cancer treatment alone appears very promising, the company's true potential could be much larger. The same cellular signaling pathways are implicated with a variety of metabolic, neurodegenerative, and fungal diseases, which means that the company's same approach could be used in those markets. As a platform play, management could ultimately out-license the technology in these areas.
For more information, please see the company's website at www.lixte.com.
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Except for the historical information presented herein, matters discussed in this release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Emerging Growth LLC is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release.
SOURCE: Emerging Growth LLC