Clinical Trial for Cats with Oral Squamous Cell Carcinoma

MBF Therapeutics has entered into clinical trial agreements with two sites that will be collaborating on a clinical trial for the investigation use of MBFT-101 against oral squamous cell carcinoma in cats. Those two sites are:

Hope Veterinary Specialists in Malvern, PA

For more information please contact their oncology service.

Phone (610) 296-2099

Fax (610) 296-2444

Email: oncology@HopeVS.com

Website : http://hopevs.com/specialties/clinical-trials/

Katonah Bedford Veterinary Center in Bedford Hills, NY

For more information please contact their oncology service.

Phone: (914) 241-7700

Fax: (914) 241-7708

Email:  Philip.Bergman@vcahospitals.com

Website: http://www.vcaspecialtyvets.com/katonah-bedford

What is Squamous Cell Carcinoma (SCC)?

Squamous cell carcinoma (SCC) is the most common oral tumor in cats (~70%). Most cats with SCC are around 10 years of age. The tumor is often noted on a physical examination or during a routine dental cleaning, however, most patients present with clinical signs related to the tumor.  Clinical signs include, weight loss, abnormal chewing, bad breath, drooling and often the presence of swelling along the oral cavity. These tumors can be very aggressive and often will destroy and invade a great deal of the underlying bone. The tumor can occur either under the tongue, upper or lower jaw. Often there is a secondary infection from dead tissue surrounding the tumor.

 

Surgery alone is often not possible due to the tumor location. Cats also tend to experience high morbidity post oral surgery. There is little evidence to suggest chemotherapy alone also is effective against this disease and generally, radiation therapy is palliative in nature designed to minimize pain with little impact on tumor size or survival.

 

Clearly, no effective therapy for SCC exists at this time and novel therapies are needed. HopeVS, working with MBF Therapeutics Inc, is enrolling cats with oral squamous cell carcinoma for a clinical trial to evaluate the safety and effectiveness of a new Polyamine-Based Therapy (PaBT™), a combination of two novel anticancer agents (2-diflouromethylornithine (DFMO), an ornithine decarboxylase (ODC) inhibitor, and MBF 1569, a polyamine transport inhibitor (PTI)). This is a targeted therapy, in that each agent attacks a different aspect of the cellular metabolism of the cancer. A large body of literature indicates that tumor cells require an efficient polyamine metabolic pathway for optimal growth; thus restricting its availability via this two drug combination should beneficially impact tumor growth.  Preclinical studies suggest that this treatment may also stimulate an immune response to enhance the body’s ability to fight the tumor.

 

Previously this combination has been evaluated in cats and deemed safe and effective.  The goal of this trial is to further evaluate the safety and determine an optimal dose of this combination. This study is funded to cover costs of the examinations, bloodwork and the agent is provided at no cost. Patients responding will be able to continue on compassionate usage for 6 months.

Inclusion Criteria:

Cats must be deemed to be in otherwise acceptable systemic health based on results of physical examination, complete blood count, serum chemistry screen, and urinalysis. Patients deemed in poor body condition as a result of the primary tumor will not be eligible for enrolment.

 

  • Oral SCC that is in a location in which repeat measurements are feasible.

  • Cats should have a life expectancy of at least one month.

  • Cats that have failed conventional therapies are eligible with a 2 week washout period. This includes nonsteroidal and steroid medications.

  • Other pain medications may be prescribed as needed, including tramadol at 2-4 mg/kg q8-12h or Buprenorphine 0.01mg/kg sublingual BID.

  • A consent form must be signed by the pet owner.

Exclusion Criteria:

  • Patients may be excluded from the study if tests indicate spread to regional or distant sites.

  • Patients may also be excluded from the study if the severity of the tumor is already significantly affecting quality of life.

  • Cats with pruritus due to skin disease are excluded from the study.

  • Cats with chronic renal, hepatic or cardiac failure are excluded from the study.

 

 

 

 

 

 

 

 

 

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