| HST Global, Inc. (OTCBB: HSTC) |
Recent Share Price: $ 2.50 (7/16/08)
Shares Outstanding: Approx. 20 million
Market Cap (approx): 60 million
52 HSTC high/low: 2.25 / 22.75
HST Global, Inc. is a development stage biotechnology company that acquires, develops and licenses innovative products for the treatment of cancer. HST has licensed a pre-clinical drug called Salicinium for the treatment of Stage IV breast cancer. Salicinium has shown a 72% efficacy over a 2 1/2 year testing period of 58 stage IV patients or that 46 have survived.
HST Global, Inc. is publicly traded on the over-the-counter market under the ticker symbol HSTC.
Highlights:
- HSTC currently have rights to one clinical stage drug candidate:
- Salicinium - Salicinium is an oral and parental active inhibitor of NAD+ fermenting enzyme dynamics. Clinical studies demonstrate that Salicinium alters malignant cell fermentation dynamics, blocks cell division (mitosis) and causes fermenting (cancer) cells loss of ability to withstand the innate immune reactions.
- Currently, HSTC have entered into a letter of intent for our product candidate, and the entities from which HSTC have entered into agreement with have either obtained or applied for patent protection for such product. With respect to the product, HSTC does not anticipate significant expenses in obtaining and maintain patent protection on our (and our licensees') behalf, unless and until a claim or assertion of infringement arises.
- Of the patients studied, 58 were diagnosed with stage IV breast cancer. The results after 2 1/2 years show 74% efficacy, or that 46 of the patients survived. Based on this and other pre-clinical trials performed to date, HSTC believes that Salicinium has potential applications in the treatment of stage IV breast cancer.
- Over the course of the next year, our plan of operation is to retain our executive officers and the initial members of our board of directors, and hopefully begin FDA testing of our pre-clinical stage drug. HSTC entered into a licensing agreement of our product candidate in December. HSTC continue to search for additional cancer applications for our product candidate.
HSTC Business Model and Strategy
HSTC focuses on in-licensing (the licensing of technologies developed and owned by other parties) and further developing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer. Although the cost of licensing drug candidates for which the initial clinical testing has been completed may be significantly higher than those for which clinical testing has not been completed, HSTC believes there is significantly less risk associated with its investment and continued development of clinical stage drugs due to the fact that HSTC is able to obtain an initial indication of the drug's safety and efficacy before HSTC decides to invest capital in the drug's development.
HSTC considers potential drug acquisitions through a number of sources, including solicitations from potential sellers of such drugs and through searches completed by both our directors and by independent consulting firms. In considering potential acquisitions, HSTC completes an evaluation of the scientific and medical viability of the drug. Depending on the drug, this evaluation is completed by HSTC internally if any of the members of its team have specific experience with the related technology, or by third party consultants with specific experience with the related technology. In addition to scientific and medical viability factors, HSTC also considers the drug from a market perspective, considering not only the prospective expense of development and commercialization of the drug, but also the economic potential of the drug on such market if successfully developed.
Internal evaluation, when undertaken, is completed by the Company's Scientific Advisory Board, whose members, headed up by Dr. James Forsythe, assist management in the assessment of research, development and commercial programs of biotechnology or pharmaceutical companies that HSTC may consider acquiring and provide advice and guidance with respect to the research and commercial development plans of our product portfolio. HSTC will not enter into any licensing transaction unless our board of directors has first approved the transaction. Its decision will depend on several factors, including the scientific merits of the technology, the costs of the transaction and other economic terms of the proposed license, the amount of capital required to develop the technology, and the economic potential of the drug candidate should it be commercialized.
Currently, HSTC does not follow any policy or formula as to our acquisition of product candidates, other than seeking drugs for which pre-clinical or clinical testing has commenced. To date, HSTC have executed an LOI to acquire one product candidate, which must be followed by formal agreements and further finalization. HSTC will continue to consider potential acquisitions based on the consideration of the factors identified above.
As HSTC moves its product candidates through development toward regulatory approval, HSTC will evaluate several options for each product candidate's commercialization strategy. These options include building its own internal sales force, entering into a joint marketing partnership with another pharmaceutical or biotechnology company whereby HSTC jointly sells and markets the product, and out-licensing its product whereby another pharmaceutical or biotechnology company sells and markets our product and pays us a royalty on sales. HSTC's decision will be made separately for each product and will be based on a number of factors including capital necessary to execute on each option, size of the market that needs to be addressed and terms of potential offers from other pharmaceutical and biotech companies. It is too early for us to know which of these options HSTC will pursue for its product candidates, assuming their successful development.
Our Product Candidate
In December 2007, HSTC entered into an LOI with Brown Technologies, a California corporation, for the exclusive, worldwide rights to Salicinium. This natural substance, which is plant-derived, is both an oral and parenteral active inhibitor of certain fermenting enzyme dynamics in the cancer cells. Clinical studies demonstrate that Salicinium alters malignant cell fermentation dynamics, blocks cell division (mitosis) and causes fermenting (cancer) cells' loss of ability to withstand the innate immune reactions.
Given parenterally, in the form of the Forsythe Immune Therapy #2, the I.V. contains proprietary amounts of normal saline, magnesium chloride, vitamin B6, Vitamin B12, B complex, folic acid, vitamin C, L-Lysine, zinc, glutathione, and the main ingredient "salicinium". The preparation is succussed at the time of the patient's visit, and it is prepared in approximately a 1:50 dilution.
Salicinium has the distinct advantage of having been studied in over 250 human stage IV (terminal) cancer patients in Reno, Nevada. Stage IV Breast cancer patients are usually treated with the following drugs in the appropriate order:
- 1st line stage IV are often treated with Taxane +/- Avastine
- 2nd line stage IV are often treated with Xeloda +/- Avastine
- 3rd line stage IV are often treated with Navelbine +/- Avastine
Of the patients studied, 58 were diagnosed with stage IV breast cancer. The results after 2 1/2 years show 79% efficacy, or that 46 of the patients survived. Based on this and other pre-clinical trials performed to date, HSTC believe that Salicinium has potential applications in the treatment of stage IV breast cancer.
The ongoing study was conducted by Dr. James Forsythe who is both a Medical Doctor and a Homeopathic Physician. Dr. Forsythe is a Director of the Company and heads the Company's Scientific Advisory Board. Dr. Forsythe has been a clinical oncologist for 34 years and has done many clinical studies, but has stated that he has never seen a candidate with pre-clinical outcome based results as favorable as this one. The study was conducted under Homeopathic guidelines governed by the state of Nevada.
HSTC intend to use the results of this study in our effort to apply for Food and Drug Administration ("FDA") approval. Management believes that the Company will be successful in obtaining such approval in the future, although there can be no assurances to this effect.
Report by the Scientific Advisory Board
The following summarizes the findings of HSTC's Scientific Advisory Board with respect to the ongoing clinical trials:
The purpose of the pre-clinical outcome-based study in Stage IV adult cancers is to study efficacy and safety issues. All patients coming to the clinic are given the following choices:
- Conventional chemotherapy, either first, second or third line, as appropriate to the patient's prior history;
- Conventional chemotherapy, either standard or low-dose fractionated, with salicinium;
- Conventional dose or low-dose fractionated chemotherapy with salicinium and other complimentary products;
- Salicinium along with other complimentary therapies;
- Salicinium alone;
- Insulin potentiated therapy using standard chemotherapy with salicinium; and
Any of the above plus hormonal therapies.
- Any of the above plus hormonal therapies.
This study was carried out from June of 2005 through March of 2008, with 250 Stage IV cancer patients under study.
The advantages of the pre-clinical study were to show efficacy and safety, and freedom from adverse toxicities and adverse side-effects. The conclusion of the study was that salicinium is a novel, homeopathic, immune boosting therapy that when used alone in breast cancer , isolated from the other cancers, showed an overall response rate of 78% at 33 moths.
When salicinium was used in combination with Poly-MVA and/or chemotherapy, the overall response rate was 70%.
In the entire study there were 13% complete remissions, 16% partial remissions, and 41% stable diseases, with an overall 30% expiration rate.
These results compared favorably with conventional chemotherapy alone which, in five years in the allopathic literature from 2004, showed only a 2.1% survival rate in the United States with any form of chemotherapy alone.
It is important to note that this product is compatible with other complimentary therapies, such as Poly-MVA, which vector in on the metabolism of the cancer cell in a different matter.
Also of great importance is the fact that there were no significant adverse events in the 250 patients using salicinium, even when used with low-dose fractionated chemotherapy.
Results of Clinical Trials for Salicinium
The following summarizes the results of the ongoing clinical trials:
Total number of breast cancer patients = 58.
Total number of expirations = 12 or 21%.
Total surviving = 46 or 79%.
Total number receiving Glyco-benzaldehyde only = 9.
Total number of expirations = 1 or 11%.
Total surviving = 8 or 89%.
Total number receiving Glyco-benzaldehyde plus Complementary = 22.
Total number of expirations = 5 or 23%.
Total surviving = 17 or 77%.
Total number receiving Glyco-benzaldehyde, Complementary plus Chemotherapy = 20.
Total number of expirations = 5 or 25%.
Total surviving = 15 or 75%.
Total receiving Low-dose Conventional Chemotherapy plus Glyco-benzaldehyde = 7.
Total expirations = 1 or 14%.
Total surviving = 6 or 86%
Management Team
Ronald R. Howell - Chief Executive Officer / Chairman, has over 30 years of diversified leadership experience. He has distinguished himself in various businesses and held executive positions in various industries including real estate, distribution, national and international sales, wholesale and retail marketing, and financial service. Most recently before joining HST Global, Mr. Howell was CEO and President of The Health Network, Inc., a direct sales and marketing company in the nutraceutical industry, for over 5 years. Mr. Howell holds a Bachelor's Degree in Management from UMB and an MBA from the Sellinger School of Business and Management at Loyola College. Mr. Howell has also taught as an Adjunct Professor at Loyola College in Baltimore, MD and served his country as a United States Marine.
Wesley D. Tate - Chief Financial Officer and Secretary, has spent almost 15 years in the Direct Sales Industry working with a number of different companies. Mr. Tate served as Executive Vice President and Chief Operating Officer for InnerLight Inc. in Provo Utah for over five years. He was also Assistant Chief Financial Officer for Beverly Sassoon and Co. in Boca Raton, Florida. He also has experience outside the direct sales industry, having worked with a number of Fortune 500 companies. At UT Knoxville Mr. Tate received both a Bachelor of Science degree from the (with majors in finance and psychology) and an MBA (in finance and management). Wes served his country in the United States Army.
Contact Us
HST Global, Inc.
150 Research Drive
Hampton, VA 23666
(757) 766-6100
www.hstglobal.com
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