Sterile processing of anti-cancer drug to be used to treat pets with cancer

Vero Beach, Florida
BiologyMedicine
Open Access
$120
Raised of $10,440 Goal
2%
Ended on 1/09/14
Campaign Ended
  • $120
    pledged
  • 2%
    funded
  • Finished
    on 1/09/14

About This Project

Our goal is to treat pets with cancer using nitrosylcobalamin (NO-Cbl). NO-Cbl represents a new class of anti-tumor drug. We modeled our compound after vitamin B12 to target cancer. NO-Cbl has been used to treat cancer in mice and dogs without side-effects. It is critical to the success of our clinical study that NO-Cbl is prepared and provided to veterinarians in a sterile dosage form so that pets can be treated safely.

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What is the context of this research?

The Bauer Research Foundation is a not-for-profit charity. Our goal is to help in the FDA approval process for nitrosylcobalamin (NO-Cbl), for the treatment of cancer in companion animals (pets).

NO-Cbl represents a new class of anti-tumor drug, and is a targeted vitamin B12-based agent that has demonstrated antitumor activity in vitro (cancer cells in tissue culture) as well as in xenograft tumor models (transplanted human or dog tumors in mice) and in spontaneous tumors in dogs (pets with cancer).

In a published case series of 4 dogs treated with NO-Cbl for which we have long-term follow-up, complete tumor resolution was observed in 3 of 4 dogs (anal gland adenocarcinoma, spinal meningioma, peripheral nerve sheath tumor); a 77% reduction in tumor size was observed in 1 dog (thyroid carcinoma), but the dog was humanely euthanized after 6 months of NO-Cbl treatment due to severe arthritis which had been diagnosed prior to the start of NO-Cbl therapy and which was unresponsive to conventional arthritis treatment regimes.

Thus far, no adverse effects have been observed in any dogs treated daily with NO-Cbl, ranging in duration from 4 months to 3 years.

We have recently completed and published a study quantifying vitamin B12 receptor expression in 30 canine tumors; we were able to show that every tumor expressed the vitamin B12 (and hence NO-Cbl) receptor, and that receptor expression was significantly increased in tumor tissues compared to adjacent normal tissues.

We propose to conduct a 50 dog clinical trial that will permit us to expand our safety, efficacy, pharmacokinetic and biomarker data. Collection of this data will be beneficial for both our FDA regulatory requirements as well as for attracting future investor financing.

We have 10 committed veterinary clinical trial sites with sufficient caseload to be able to accrue 50 cases within a 4-6 month period. We currently have a site that is able to manufacture cGMP-grade NO-Cbl in up to 2 kg batch sizes.

However, we need to reconstitute the NO-Cbl powder in a sterile diluent then sterile filter and transfer the NO-Cbl to sterile vials. A Baxa repeater pump will provide us this option. In this way we can ensure the sterility and safety of the product.

What is the significance of this project?

Over the last decade, dogs and cats have gained a place as members of the family, and are offered health care that is comparable to human standards. Pet ownership and pet spending are increasing globally, and industry sources report that pet owners would rather reduce spending on lifestyle expenses such as entertainment, clothing and household goods before reducing spending on pet care.

Of the 70 M pet dogs and 74 M pet cats in the United States, approximately 8% will develop cancer each year. Surprisingly, there are currently only 2 FDA-approved veterinary drugs for the treatment of cancer in companion animals, and they are labeled solely for the treatment of mast cell (skin) tumors in dogs. Many dogs and cats with cancer are routinely treated with approved human oncology drugs that have been adapted to pet use with modified dosages and dosing regimens ('extra-label use'). Unfortunately, many of these agents fail to produce a positive long-term clinical benefit, and unacceptable toxicities often result in the need for supportive care, withdrawal of therapy and decrease in quality of patient life. Furthermore, many chemotherapeutic agents require special handling by trained personnel, and pets must be hospitalized to receive these therapies. Both veterinarians and pet owners are seeking an effective and less traumatic alternative for the treatment of cancer in companion animals.

The use of vitamin B12 to target NO-Cbl to cancer cells, no matter how small they are or where they are located, represents a mode of therapy that is novel to cancer treatment in both humans and companion animals. NO-Cbl provides a safer and more effective way to kill cancer cells, and its targeted action represents the future direction of cancer therapy in both humans and pets. Clinical use of NO-Cbl has not been associated with any adverse side effects. There is a high demand for NO-Cbl both in the United States and internationally, as evidenced by to-date receipt of over 3,500 unsolicited requests for the drug from veterinary oncologists, veterinary practitioners and pet owners across the world.
©Bauer Research Foundation

What are the goals of the project?

Our project will be conducted in a step-wise fashion. First, we will use the funds to purchase a Baxa Repeater Pump from Baxter Scientific which allow us to produce NO-Cbl under sterile conditions to provide dosage forms to support a clinical trial.

Secondly, once we fund a 50 dog study, the NO-Cbl will be sent to veterinary clinics that are participating in the study.

The results of the study will be submitted for scientific publication and will be submitted to the FDA per the formal drug approval process for animals.

Budget

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The costs include that of the Repeater (pharmacy) Pump itself at $5,700 and disposable/consumable supplies need for sterile filtering and finish (bottle fill) at $4,740.00, for a total project cost of $10,440.00

Meet the Team

Dr. Joseph A. Bauer
Dr. Joseph A. Bauer

Team Bio

Dr. Bauer became one of the youngest Staff Scientists in translational medicine at the Cleveland Clinic's Taussig Cancer Institute. He has over 18 years of experience in drug discovery and development, and 13 years of experience in cancer medicine. Dr. Bauer also holds a degree in Business Administration from Walsh University.

Dr. Sysel has over 22 years of experience as both a private practice veterinarian and as a surgeon at the Ontario Veterinary College and the Virginia Maryland Regional College of Veterinary Medicine.

Dr. Dunphy is the Chairman of the Division of Math and Sciences and a Professor of Chemistry at Walsh University. Dr. Dunphy has over 36 years of experience in chromatography and quantitative sciences and bio-analytical research.

Dr. Lupica has over 9 years of experience in cancer medicine, and he spent 6 years as a Research Fellow at the Cleveland Clinic's Lerner Research Institute. He is currently a Visiting Professor of Chemistry at Walsh University.

Lab Notes

Nothing posted yet.

Press and Media

1. 'Miracle Dog' Beats Aggressive Cancer, WebMD 2009 http://www.webmd.com/cancer/news/20090323/miracle...
2. Dogs Help in Hunt for New Cancer Drugs, US News & World Report, 2009 http://health.usnews.com/articles/health/healthda...
3. Dr. Joseph Bauer ’94 Vitamin B12 may be Trojan Horse in war on cancer. Walsh Times. December 2009 http://health.usnews.com/articles/health/healthda...
4. Walsh Students Involved with Cancer Research Thanks to Collaboration with Alumni-Owned BNOAT Oncology. Walsh Times. July 2011 http://health.usnews.com/articles/health/healthda...
5. Research of Anti-Tumor Drug May Lead to First Feline Cancer Treatment. Purina ProClub Update. July 2013. http://health.usnews.com/articles/health/healthda...

Additional Information

Research on the Trojan Horse, NO-Cbl, spans more than 15 years and includes 9 scientific publications in peer-reviewed journals.

Refer to NIH National Library of Medicine (PubMed):

http://www.ncbi.nlm.nih.gov/sites/myncbi/collectio... For information on the Repeater Pump, please visit the link below:

http://www.baxtermedicationdeliveryproducts.com/ph...






Project Backers

  • 2Backers
  • 2%Funded
  • $120Total Donations
  • $60.00Average Donation
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