Addressable Market

The initial market for ST-001 in the oncology community is a treatment modality for patients suffering from non-Hodgkin’s lymphoma. SciTech has chosen the B-cell malignanices, including Non-Hodgkins Lymphoma as the initial indication to pursue, as other studies correlate elevated serum levels of Fenretinide to strong efficacy. Unfortunately, there are 400,000 people in the US with some variant of non-Hodgkin’s lymphoma.  The NCI estimated that 35,450 men and 30,670 women would be diagnosed with and 19,160 men and women would die of non-Hodgkin lymphoma in 2008. The 5-year relative survival rate of patients with NHL is approximately 63%. The combined high prevalence and comparatively long survival rates suggests a large market with patients utilizing multiple treatment modalities and multiple cycles of those modalities. According to Frost and Sullivan, "The relapsing nature of NHL is impelling the need for new therapeutic options... Though MabThera is very popular and has gained widespread acceptance, there still exists a high unmet need among NHL patients."

Once the efficacy of ST-001 is shown in NHL, SciTech can then prudently consider pursuing additional cancer indications, as appropriate. Pancreatic cancer is of substantial interest for two reasons:

1) The disease still has a very high mortality rate / unmet need

2) Fenretinide has been shown to selectively partition from ST-001 at the pancreas (i.e., it targets the pancreas).

Only 19% of those diagnosed with pancreatic cancer survive one year while only 4% survive five years. This ties pancreatic cancer with liver cancer as the most deadly form of cancer. Any drug improving survival in this indication is expected to gain FDA approval – potentially prior to completing Phase III studies.

In previous studies, Fenretinide has shown potential efficacy in eight different cancer types, including NHL, pancreas, head & neck, bladder, breast, renal cell, leukemia and neurological tumors. A new deadly new form of breast cancer, referred to as Triple Positive, also shows market possibilities similar to those of pancreatic cancer for the same reasons. One of our potential clinical trial sites is very interested in pursuing this disease. This bodes well for off-label prescribing (i.e., prescribing a drug for an indication for which it has not yet received FDA approval), which is commonplace in oncology treatment. Perhaps the best example of this is Celgene’s Thalomid, which was approved for leprosy, but prescribed greater than 90% for the treatment of multiple myeloma. Thalomid sales exceeded $400 million in 2006, and are expected to exceed $500 million in 2010.

ST-001: Fenretinide for Intravenous Use in Anticancer Chemotherapy (Lead Product). Fenretinide has been tested for over 26 years and has proven effective in preventing breast cancer and has potential in treating cancer with the right product formulation. The intravenous (IV) drug delivery system developed for Fenretinide is a unique platform technology that takes the form of a lipid nanoparticle that differs from typical lipid vesicle technology.  Traditionally, a drug is solubilized in the aqueous internal chamber of the liposome for prolonged drug release and distribution. Concurrently the polar head groups of the lipids on the outside surface are derivatized to avoid rapid removal from the blood by the reticuloendothelial system in the spleen and liver. The current free flowing drug delivery platform, however, involves the specific incorporation of a water insoluble anti-cancer drug within the lipid bilayer of the vesicle. The use of particular ratios of synthetic phospholipids with known fatty acid chain lengths and polar head group chemistry in our formulation allows for better control of particle stability, drug product potency and shelf life. The composition of the delivery system is so fully defined and high strength that the potential for adverse effects from exposure to common excipients, such as surfactants and triglycerides, is minimized.  Therefore potential clinical adverse effects such as hypertriglyceridosis can be avoided. There is no known existing product or product under development, other than ST-001, that incorporates all of these important attributes. Clearly, such added precision, as afforded by this design could facilitate greater delivery of a plethora of neutral retinoids and other membrane seeking drugs by increasing deliverable drug strength without creating new side effects.  The first product using this technology to move into clinical development will be our intravenous Fenretinide product (ST-001) for the treatment of B-cell malignancies.

One could consider our initial focus on developing the ST-001 as a system for delivering this well known and highly tested anticancer agent, Fenretinide, as taking advantage of the low hanging fruit. The risk reduction resulting from years of scientific and clinical study of Fenretinide, coupled with SciTech overcoming its major performance obstacle, creates a huge opportunity.

ST-001 also has the potential to deliver other drugs in combination with Fenretinide in a single nanoparticle. ST-001 has a hydrophilic center, which potentially enables delivery of hydrophobic and hydrophilic compounds simultaneously. This concept is especially important when noting that Fenretinide selectively partitions at the pancreas. Gemzar, the standard of care for pancreatic cancer, is a hydrophilic compound that may be deliverable in combination with Fenretinide, targeting the pancreas more effectively. Gemzar is but one example of many with the potential for high value combinations. Methotrexate and as previously stated, Rituxan are other anticancer compounds with potential for combination with Fenretinide in ST-001.

ST-001: Future Embodiments of Fenretinide. There is a strong consensus in the medical community that the best hope for treating the various cancer indications lays in the use of these combination therapies. Putting it another way, it is unlikely that any single drug will cure the disease. It is incumbent on SciTech to collaborate with, or license technology to, established drug development companies in order to create combination therapy regimens. The portfolio of products that could flow from the execution of such a strategy is very large. SciTech has commenced an effort, parallel to the incubation of Fenretinide-based products, by targeting pharmaceutical companies to partner in the development of other drugs to be delivered by our technology