Earlier this week, we announced the introduction of Palbociclib as part of our veterinary oncology toolbox, but we’re not done!
Today, we are proud and excited to announce the addition of Olaparib, a drug that will increase the number of actionable targets FidoCure® can address.
Olaparib is a Poly(ADP-ribose) polymerase (PARP) inhibitor. PARPs are enzymes that are activated by DNA damage and facilitate DNA repair for single-strand breaks.
Inhibitors of this enzyme, PARP, result in the accumulation of single-strand DNA breaks eventually leading to highly cytotoxic double-strand breaks. If the cancer cell cell has a well functioning BRCA pathway, these double-stranded breaks can be repaired and the cell can survive.
However, in cells where the BRCA gene(s) are mutated and non-functional, these double-stranded breaks result in the death of the cell.
Inhibiting one pathway in a cell where another pathway is not functioning, for the purpose of killing that cell is called synthetic lethality. This is exactly the rationale for using Olaparib to treat cancers where the BRCA genes are mutated.
Preclinical toxicology and pharmacokinetic studies of Olparib in dogs are available as scientific manuscripts and as published components of regulatory submissions to the U.S. Food and Drug Administration (FDA).
Over 20 dogs in 3 different Olaparib dose cohorts were evaluated in a 26-week study to examine the relationship between dosage and adverse effects and determined a safe dose for this drug.
The U.S. FDA approved Olaparib for human use in 2014.
Use of Olaparib is extra-label in canines. Hence, it can be prescribed by a veterinarian, but only by a veterinarian with a valid veterinary-client-patient relationship in a manner consistent with the provisions of the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA).
Extensive Quality Control
Prior to being added to our formulary, the drug underwent weeks of extensive testing to ensure quality, purity, strength and identity were in accordance with USP standards. Testing was performed through Wedgewood Pharmacy, one of the largest specialty compound pharmacies in the US.
In canine cancer, we expect Olaparib to be a potential option in cancers with BRCA mutations or when the use of synthetic lethality may be helpful, such as in cases with mutations of some tumor suppressor genes .
As with all of the therapies available, we establish a starting dose based on toxicity studies in healthy beagle dogs from the preclinical data in the human FDA approval package.
This means we start at or below the No Observable Adverse Event Level (NOAEL). This is the same way we will introduce dosing Olaparib, giving quality of life the highest priority.
We look forward to being able to help more of your patients by facilitating access to Olaparib and are continuing to work hard to advance our research and enable even more targeted therapies for additional mutations.