|Lixte Biotech: Promising Anti-Cancer Compounds in Early Development|
|Wednesday, 12 August 2009 17:16|
Lixte Biotech (LIXT.OB) 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).
Lixte is focused on securing a strategic partnership this year with an established pharmaceutical company to provide the necessary funding for these research initiatives since the Company does not currently generate revenue from its operations. The Company has made preliminary presentations to several large pharmaceutical companies for its lead compounds (in addition to chemical derivatives of these compounds), which have the effect of modifying critical pathways in both cancer cells and microorganisms such as fungi that appear to result in a protective effect on neural tissues such as the brain.
On 8/12/09, Lixte filed its SEC 10Q quarterly report, which included the following financial updates: (1) As of 7/31/09, the Company had 29,352,178 shares of common stock outstanding; (2) At the end of 2Q09, Lixte had $165,707 in cash/equivalents; and (3) For the six months ended 6/30/09, the Company's operating activities utilized cash of $341,724 versus $306,135 for the year-ago period.
Lixte provided previous guidance for a minimum requirement of $750,000 during 2009 to fund operations and attempt to bring two compounds through preclinical evaluation for the submission of an IND application. Three closings of private placements resulted in net proceeds of about $597,000 with $100,000 being used to repay a short-term note earlier this year. Lixte has modified its budget for 2009 based on available funding and currently expects to continue the development of its two lead compounds while pursuing strategic partnerships or another private placement in 2H09 to raise additional capital and possible expand upon existing research activities.
Since Lixte did not reach its target of $750,000 in a private placement earlier this year, the Company has modified its 2009 budget to reflect the available operating funds and believes that its current resources are adequate to fund operations at most through the end of 2009 at a level that will allow the continuation of the two drug development programs currently in process. Depending on the results of the Company's efforts to enter into a strategic partnership with a large- or medium-sized pharmaceutical company that would provide adequate financial resources for the Company to continue its research and development activities, the Company may consider a further private placement later in 2009. Lixte is engaged in various preliminary discussions with regard to a potential strategic partnership.
If the Company is able to achieve support from and/or partnership with a large pharmaceutical company to co-develop its compounds, this schedule may be accelerated. The drugs are well characterized from the standpoints of activity and mechanism of action. The pre-clinical activity toxicology and pharmacokinetic characterization, which are elements needed for IND submission, could be accomplished quickly with adequate financial resources or by a partner with expertise in characterization of drugs for introduction into the clinic.
The 10Q filing also noted that the Company has entered into an amendment to the CRADA to extend its term from September 30, 2009 through September 30, 2011. Lixte's research on brain tumors is proceeding in collaboration with the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) under a Cooperative Research and Development Agreement (CRADA) entered into on 3/22/06, as amended. The research at NINDS continues to be led by Dr. Zhengping Zhuang, an internationally recognized investigator in the molecular pathology of cancer. Dr. Zhuang is aided by two senior research technicians supported by the Company as part of the CRADA.
In early July, Lixte announced that the results of studies characterizing the novel and potent anti-cancer activity and mechanism of action of its novel 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.
Dr. Kovach remarked that, "Since LB-1.2 has a biochemical action similar to an older drug used for anticancer treatment for many years in China, we are cautiously optimistic that LB-1.2 will be well tolerated by cancer patients and hopefully, will potentially be as effective as it is in animal models of human cancer. We believe that adding LB-1.2 may be a general method for improving the effectiveness of several standard anticancer drugs not only against tumors of the brain and neural tissue but also against other cancers sensitive to drugs that work by damaging DNA. Safety, of course, must be demonstrated first in animal studies and subsequently in Phase I clinical trials before evaluation of therapeutic effectiveness can be assessed against different cancer types in patients."
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.
The Company's primary goal is to begin preclinical studies for its two lead compounds, which is a requirement for submitting an IND application to the FDA to begin human clinical trials. Lixte will choose its lead compound based in part upon discussions with the Agency at a pre-IND meeting and the Company will also begin preclinical studies for a second compound if sufficient resources are available. The secondary goal for Lixte is to further characterize the anti-fungal activities for select derivative compounds of the LB-200 series, which will be done in collaboration with academic partners. The Company recently confirmed that its lead compound of the LB-200 series has shown the potential to safely (no evidence of toxicity was observed) cure two common types of fungal skin infections in a guinea pig model through topical application of the compound on a daily basis for two weeks.
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.
Lixte anticipates that remaining pre-clinical activity, toxicology, and pharmacokinetic characterization could be accomplished quickly with adequate financial resources or through a strategic partner with expertise conducting such studies. The Company is also exploring the synthesis of additional novel anti-cancer drugs. Several targets for anti-cancer drug development are under consideration. When the next group of compounds is developed, it will be designated as "LB-3", as distinguished from the first two classes of compounds that were designated as "LB-1" and "LB-2". This process is currently in the planning stage and no compounds have been made as yet.
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 does not have any full-time employees with John S. Kovach, M.D., serving as the Company's sole administrative officer and founder. Dr. Kovach is a part-time Professor in the Department of Preventive Medicine at the State University of New York. He received approvals from the School of Medicine of Stony Brook University and from the New York State Ethics Commission to operate the Company and to hold greater than 5% of our outstanding shares. Dr. Kovach has not received any compensation from the Lixte since its inception in August 2005.
Please visit the stock research section of BioMedReports.com to view or download my stock profile report for Lixte Biotech and also check out the Lixte's Pro-Active News Room site for a compilation of links, videos, presentations, and social media sites for the Company.
Disclosure: No positions.