Frequently Asked Questions
Who is SciTech Development?
SciTech Development is an emerging pharmaceutical company that is developing new cancer drugs including its lead drug candidate ST-001 nanoFenretinide. SciTech is currently seeking investors and partners to bring its fenretinide technology to market.
Does SciTech have any FDA approved drugs?
Where is SciTech located?
SciTech operates virtually and is headquartered in the Metro Detroit Area in Michigan.
What types of cancer is SciTech targeting?
T-cell non-Hodgkin's lymphoma (T-cell NHL), small cell lung cancer (SCLC), metastatic breast cancer (MBC), neuroblastoma, T-ALL (acute lymphoblastic leukemia), breast, cervical, colorectal, head & neck, leukemia, ovarian, kidney, pancreatic and prostate cancers.
Why so many cancer targets?
These are all cancer indications in which our active pharmaceutical ingredient (API) fenretinide has shown promising results in pre-clinical or clinical studies. The company is initially targeting T-cell non-Hodgkin's lymphoma (T-cell NHL) and small cell lung cancer (SCLC).
What is SciTech's cancer drug treatment?
SciTech’s drug candidate is ST-001 nanoFenretinide which is administered intravenously (IV) on an out-patient basis. ST-001 consists of nanoparticle-sized fenretinide in a phospholipid matrix. Fenretinide is a well-known drug with a well-documented safety profile which has been studied in both humans and animal models.
If fenretinide is well-known, why hasn’t it been commercialized already?
The problem with fenretinide has been its poor bioavailability (limited water solubility) which has impeded its development as a drug. SciTech has overcome this limitation with its patented nanoFenretinide technology.
What are SciTech's product sales and revenue?
SciTech does not have any products on the market or any commercial revenue yet. We are currently seeking investors and partners to bring our nanoFenretinide technology into the clinic and eventually to market.
What type of investors and partners is SciTech looking for?
We are currently closing on a Convertible Note Round (CNR) of funding and will be seeking a Series A equity investment to bring our lead drug candidate ST-001 nanoFenretinide to market for the treatment of T-cell NHL and small cell lung cancer (SCLC). We are seeking partners with the resources to manufacture, distribute and sell our potential drug products.
Does fenretinide or nanoFenretinide have FDA drug approval?
No. The FDA has recently approved SciTech’s Investigational New Drug (IND) application for ST-001 nanoFenretinide treatment of T-cell NHL. The FDA approved IND provides clearance for ST-001 nanoFenretinide to enter the clinic. The FDA has also granted Orphan Drug Designation for ST-001 nanoFenretinide treatment of T-cell NHL providing marketing exclusivity and tax credits.
Is SciTech’s technology patented?
Yes. SciTech has patents issued covering ST-001 nanoFenretinide compositions, ST-001 drug combinations, and the delivery platform for limited water-soluble drugs (U.S. Patent No. 8709379B2 E.U. Patent No. 2013016).
Who can I contact about investing in SciTech or partnering with SciTech?
Contact David Schaffer | (727) 278-8188 | email@example.com
What is fenretinide?
Fenretinide is a synthetic derivative of naturally occurring retinol (vitamin A) & retinoic acid and is in the retinoid class of chemical compounds.
What are the physical properties of fenretinide?
Fenretinide is a small organic molecule comprised of carbon, hydrogen, oxygen and nitrogen with a molecular weight of 391.5 g/mol; it is a water insoluble (hydrophobic) orange yellow powder.
Does fenretinide have biological activity?
Yes. Clinical and pre-clinical studies support the use of fenretinide as a treatment in several types of cancer as well as in the treatment of cystic fibrosis, rheumatoid arthritis, macular degeneration and Stargardt disease.
Where does fenretinide come from?
Fenretinide is synthetic. It was first synthesized in the 1960s by Robert J. Gander at the Johnson & Johnson (J&J) pharmaceutical company for dermatological applications (including acne).
What is fenretinide's biological or drug mechanism of action (MOA)?
Fenretinide targets multiple MOAs which gives it a broad therapeutic reach. It is selectively cytotoxic and destroys cancer cells by inducing apoptosis (a form of programmed cell death). The drug also works by other, yet unknown mechanism(s).
Are there any fenretinide drugs approved by the FDA?
No. Currently there are no fenretinide drug products on the market in the United States (US) or globally. The main problem with fenretinide has been its poor bioavailability or hydrophobicity (water insolubility) which has impeded its development as a drug. SciTech has overcome this limitation with its patented nanoFenretinide technology.
What is nanoFenretinide?
NanoFenretinide is nanometer (nm) particle sizes of fenretinide; fenretinide is a well-known anti-cancer agent.
What is a nanometer (nm)?
A nanometer is a unit of length in the metric system, strictly speaking it is 1x10^-9 meters (or one billionth of a meter), about 1000 times smaller than the width of a human hair.
What is ST-001 nanoFenretinide?
ST-001 nanoFenretinide is SciTech's patented, nanoparticle fenretinide formulation in a phospholipid matrix (a carefully selected suite of phospholipids to enhance the drug bioavailability or water solubility).
What are phospholipids?
Phospholipids are a class of lipids (biological molecules) that contain a phosphate group in the molecule. Phospholipids are a major component of all cell membranes.
What are the particle sizes in ST-001 nanoFenretinide?
Generally, less than two hundred nanometers (<200 nm).
Why such small sizes for ST-001 nanoFenretinide?
Several reasons: (1) The small size allows the drug to be readily administered intravenously without causing any circulatory blockage, thereby allowing the drug to be easily distributed in the body to cancer cells; (2) The small size allows the drug product to be processed by sterile filtration, a process of removing microorganisms (e.g., bacteria) from a fluid stream without adversely affecting the drug product; and, (3) The small-sized fenretinide combined with the phospholipids in the nanoFenretinide formulation forms a nano suspension in water (aqueous suspension) thereby increasing the drug candidate's bioavailability.
What are the benefits ST-001 nanoFenretinide?
In addition to the benefits provided above, SciTech's proprietary nanoFenretinide technology allows for high drug loading (increased potency); enhanced bioavailability or increased water solubility of fenretinide and other hydrophobic drugs (water insoluble drugs); and, triglyceride free & oil free drug formulations.
How can I learn more?
Visit our websites at www.SciTechDevelopment.com and www.SciTechSDP.com
Who can I contact at SciTech?
To learn more about SciTech and our science, contact Earle Holsapple | (313) 263-4887 | firstname.lastname@example.org