Fenretinide, a major pharma-tested and effective, targeted cancer therapy, now combined with a superior nano-particle compound offers unprecedented tolerability, far-reaching application and increased hope for sufferers. Your donation can help make this happen.
What is the critical gap in cancer treatment that you are addressing?
SciTech Development, LLC has developed a new approach for treating T-cell Non-Hodgkin Lymphoma (NHL) using a tested, proven, drug, called fenretinide. This drug was traditionally designed and tested in the prevention of breast cancer and shows promise as a treatment for many other cancers including ovarian, prostate, cervical, lung, renal, bladder, breast, glioma, skin, head and neck carcinoma, neuroblastoma, and Ewing’s sarcoma.
Fenretinide’s anticancer properties and favorable toxicity profiles in multiple organs have led to extensive clinical studies since the drug was first discovered in the late 1960’s.
One major limitation of this drug has been its inability to be administered at tolerably uniform and high enough doses to make it sufficiently effective at killing cancer cells.
SciTech has addressed this issue through the development of a new drug delivery nano-particulate medium that, combined with fenretinide, can administer this new compound intravenously (IV) at doses necessary for successful and safe cancer treatment. SciTech hopes to test this approach in other cancers, namely small cell lung cancer, renal cell, ovarian and breast cancers, where prior clinical data suggests that a fully enabled and safe fenretinide product could offer positive treatment results.
According to Dr. Timothy Kuzel, a leading clinical and research hematologist and oncologist for patients suffering from cutaneous lymphoma:
“The new formulation developed by SciTech, is an intravenously administered form of fenretinide. In reviewing accumulated data and reported experience with fenretinide, it appears that this agent may prove to be a well-tolerated, effective treatment when compared to commonly used chemotherapy regimens. Formal clinical evaluation of [SciTech’s formulation] appears well warranted.”
What is the key product development milestone you seek to fund?
SciTech seeks to reconfirm the safety and efficacy of fenretinide in its new, enabling delivery format in order to reestablish its clinical potential as a leading, safe candidate for treating numerous cancer types. This will initially be accomplished by conducting clinical trial testing with the product in the coming months. Based upon past clinical results from major pharma, early efficacy is expected with improved treatment outcomes.
Achievement of this clinical outcome would mandate its further testing in a whole host of other cancers that currently have few treatment options.
How will funds be used?
Funds will be used for manufacturing the drug/drug delivery system. The cost for manufacture is $37,000 and the cost for the ingredients are $23,000. The manufacture of this drug product, to be used for the calibration of its final manufacturing method and as well as final characterization of its chemical makeup, is mandated in order for the company to commence clinical trials.
What key resources have/will you acquire to facilitate the accomplishment of the above product development milestone?
Since receiving millions of dollars from National Institutes of Health grants, SciTech has raised $165,000 to finance the ongoing development costs. Further investments of $5M will be required and are currently being raised to support the clinical trial to fully confirm the active drug’s potential. The National Cancer Institute (NCI) is supporting this effort by providing SciTech with the required amounts of fenretinide for use in the clinical trial. This commitment reduces our manufacturing costs by hundreds of thousands of dollars. The NCI is also supporting our efforts for an accelerated FDA approval, further saving us time and money. The combined resources plus funds raised from this campaign will position SciTech to raise the larger funding levels for the clinical trial.
If your Technology were to disappear in the “Valley of Death” funding gap, how might this impact society?
If SciTech is unable to validate its product’s potential as described above, it’s possible life saving or quality of life benefits would be lost for a whole host of cancer patients whose therapeutic options are limited. Since the drug’s safety and efficacy profile has already been established, not being able to determine its possibilities would be a great loss.
As per the words of our CEO, Earle Holsapple:
“Simply put, we have enabled fenretinide, an anticancer agent that has been under development and study for decades. We have combined fenretinide with a new, simple, safe delivery system that overcomes the shortcomings of earlier versions. The collection of decades of laboratory and clinical data make the case for fenretinide’s safety and efficacy. Its use was simply hindered by its inability to be uniformly absorbed by cells. SciTech’s drug/delivery system was designed to overcome this problem and finally enable the delivery of fenretinide, safely at the required dose levels. It simply kills cancer cells while not harming healthy cells. It has both therapeutic and preventive capabilities. It has been proven safe in thousands of patients. The prospect of not being able to bring this enormously promising drug to cancer sufferers is unthinkable.”
Earle has successfully served as CEO/COO of six profitable midsize companies. He developed and raised the initial funding for the SoftVueTM technology for Karmanos Cancer Institute, It is a novel breast cancer detection product now in clinical trials with Delphinus Medical Technologies, Inc.
Mike has close to 40 years of pharmaceutical industry experience that includes R&D, product development, sales & marketing, licensing & acquisitions. He is the President and Chief Operating Officer of Ferndale Pharma Group which comprises companies that specialize in the development, manufacture, marketing, sale and distribution of a wide variety of healthcare products including prescription and over-the counter drug products and medical devices.
Ralph is an accomplished pharmacologist and principal inventor of the SciTech drug delivery technology. He presently directs a multi-laboratory program at the NCI-Frederick, NIH, where he manages the effort to create innovative approaches for evaluating and developing new drug compounds. He has worked part-time supporting SciTech’s development, patenting and commercialization activities.
Dr. Al-Katib recently retired as the Director of the Van Elslander Cancer Center at St. John Providence Health where he remains head of the hematology department. He also is a professor at the Wayne State University School of Medicine. He has extensive clinical and management experience in overseeing clinical activities. He is a lymphoma specialist with extensive experience in running clinical trials including some of those for the well-known Michigan startup, ProNAi.
Lou has 20+ years experience in technology commercialization; Principal Advisor (PA) to the Los Angeles Regional Technology Alliance’s (Larta) Life Sciences Technology Group, a PA in the National Institutes of Health and National Science Foundation Commercialization Assistance Programs (NIH CAP & NSF CAP); Founder of MVS Solutions and Kollodis BioSciences.