Lixte Biotech (OTC:LIXT): Preclinical Data Shows Enhancement of Anti-Cancer Treatments Print E-mail
Sunday, 30 August 2009 16:33

The stock research section of has been updated with my 12-page PDF stock profile report for Lixte Biotech (LIXT.ob) (OTC:LIXT) to reflect corporate and preclinical research developments along with current 2Q09 financial statistics. Other resources include Lixte's Pro-Active News Room site for a compilation of links, videos, presentations, and social media sites for the Company, including its Facebook and Twitter pages.


Lixte was originally founded as a diagnostics company in 2005 evaluating biomarkers (indicators of disease at the molecular level), but has shifted its focus to cancer drug discovery research that is primarily focused on the development of compounds for malignancies with few effective treatment options - such as certain types of brain cancer (glioblastoma multiforme or GBM, neuroblastoma, and medulloblastoma) and pancreatic cancer. Areas of secondary focus for the Company include the early-stage, preclinical drug discovery of improved anti-fungal treatments for patients with compromised immunity (e.g. HIV/AIDS and bone marrow transplant patients) and the treatment of neurodegenerative conditions such as Alzheimer's disease, Parkinson's disease, and Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's Disease).


In early July, Lixte announced that the results of studies characterizing the novel and potent anti-cancer activity and mechanism of action of its lead compound (LB-1.2) both alone and in combination with standard chemotherapy drugs were published in a leading scientific journal, the Proceedings of the National Academy of Sciences.  The primary conclusion was that one of the Company's lead compounds appears to inhibit cancer cells by stimulating cancer cells to attempt to grow in the presence of a standard cancer drug and interferes with cancer cell defense mechanisms, with the end result being much greater damage to the cancer than occurs when treatment is limited to the standard anti-cancer drug. 


The authors concluded that treatment with the Company's compound LB-1.2 may be a general method for enhancing the therapeutic benefit of a number of standard cancer regimens, not limited to the original targets of brain tumors of adults and children. Each year about 19,000 people in the United States are diagnosed with primary brain cancers, according to NCI/NIH statistics. The estimated market for the treatment of GBM is about $800M annually based on the current use and pricing of an existing drug for the condition called Temodar (temozolomide or TMZ is classified as a DNA-methylating chemotherapy drug).  Temozolomide is given to nearly every patient with a diagnosis of GBM, including about 40,000 people in the U.S. and Europe each year.


Based on the positive preclinical results for LB-1.2, Lixte believes its lead compounds have the potential to be used in combination with Temodar (for a similar commercial market opportunity) since nearly all patients with GBM relapse regardless of current treatments and the published study results offer a possible explanation for a synergistic mode of action that must be proven in human clinical trials. According to NCI/NIH statistics, the estimated number of new cases and deaths from pancreatic cancer in the U.S. for 2009 is 42,470 and 35,240, respectively, representing another unmet medical need in cancer treatment that Lixte plans to target with its lead compounds.


In addition, an abstract of the characterization of the neuroprotective effects of two lead compounds in standard assays of injury to normal embryonic mouse neurons supporting their continued development for the possible treatment of chronic neurodegenerative diseases such as Alzheimer's Disease and Parkinson's Disease have been submitted for presentation at the annual meeting of the Society for Neuroscience in November 2009.


During 1H09, Lixte filed eight patent applications that included the chemical formula of one of the Company's lead compounds (LB-100), which was found to be novel.  The Company considers this finding a milestone in the development of its intellectual property.  The specific claims for the structures and methods of synthesis of all compounds in the LB series were filed on the same day in a separate patent application and are the sole property of Lixte.  The pending review of this patent application is crucial to the Company's future business prospects since the outcome will validate the novelty of the LB-100 compounds. Lixte stated in its most recent 10Q filing that the Company is engaged in various preliminary discussions with regard to a potential strategic partnership to provide funding and support for advancing its lead compounds into human clinical trials.


One lead compound (LB-1) is the most advanced in the process and Lixte plans to be ready for IND submission in mid-2010. The other lead compound (LB-2.5), which inhibits cancer cells by a different mode of action compared to LB-1, is anticipated to complete its evaluation by the end of 2010. If the Company is able to achieve a strategic partnership and funding from an established pharmaceutical company to co-develop its compounds, the development process is expected to occur more quickly since these two lead compounds are well characterized with regards to their activity and mechanism of action. The encouraging preclinical results for LB-1.2 as an add-on treatment for brain cancer, the unmet medical needs for effective brain and pancreatic cancer treatments, and the pending patents for Lixte’s lead compound should increase the awareness of the Company’s research and hopefully result in funding to expedite the process.


Disclosure: No positions


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