INTIVA BioPharma Inc. has filed a provisional patent application with the United States Patent Office for methods and compositions for treating lipidosis. The methods comprise the administration of a drug comprising of one or more cannabinoids and/or terpenes.
Lipidosis is a term used to describe various lysosmal storage diseases in which there is an abnormal accumulation of lipids in the reticuloendothelial cells. Examples of lipidosis conditions include Gaucher’s Disease, Neimann-Pick Disease, Fabry’s Disease, Wolman’s Disease, van Bogaert’s Disease, Generalized (GM1) ganliosidosis, Tay-Sachs Disease, Sultatide Lipidosis and Krabbe’s Disease.
Lipidoses are genetic disorders, passed from parents to their children, characterized by defects of the digestive system that impair the way the body uses dietary fat. When the body is unable to properly digest fats, lipids accumulate in body tissues in abnormal amounts.
There is great variance in the symptoms, available treatments, and long-term consequences of these conditions. Some of the conditions become apparent shortly after the infant is born. In other lipid disorders, symptoms may not develop until adulthood. For most of the lipidoses, diagnosis is suspected based on symptoms and family history. There are many different symptoms that accompany these disorders, some of which include chronic pain, in the palms, soles and abdomen, edema of the legs, osteoporosis, rigidity that lead to tonic seizures and convulsions.
Tests of blood, urine, and tissue can be used to confirm the diagnosis. Genetic testing can be used, in some cases, to identify the defective gene. Some of these disorders can be controlled with changes in the diet, medications, or enzyme supplements. However, for many of these diseases, no treatment is available. Some may cause death in childhood or contribute to a shortened life expectancy.
Lipidoses are very rare. The number of people affected depends on the specific disease, but for many diseases incidence is as little as one in 40,000 people. Some of these diseases have a higher prevalence in specific populations. Many are pediatric diseases or have a pediatric form. The U.S. Food and Drug Administration (FDA) pathway for the development of drugs for many of these lipidoses fall under the Orphan Drug Act of 1983, which was passed to facilitate the development of orphan drugs.
“While the development of orphan drugs generally follows the same regulatory development pathway as any other pharmaceutical product the designation qualifies the sponsor for certain drug development incentives in an effort to encouragedevelopment of drugs for these orphan diseases,” stated Robert Goldfarb, COO of INTIVA BioPharma. INTIVA BioPharma has assembled a team of experienced professionals in pharmaceutical development and regulatory compliance for its drug development activities. INTIVA BioPharma’s team first step is anticipated to consist of the formulation of compounds that can address the symptoms of certain manifestations of lipidoses.
INTIVA BioPharma is proceeding with pre-clinical and clinical drug development activities, in accordance with U.S. Food and Drug Administration (“FDA”) protocols, for a number of pharmaceutical formulations that include cannabinoids. BioPharma’s drug development strategy consists of:
- The determination of medical conditions and disorders that could potentially benefit from cannabinoid-based formulations;
- Conducting “freedom to operate” investigations on these conditions;
- The preparation of patent applications and the prosecution of such application and/or the licensing of existing patents;
- Identifying the regulatory pathway with the U.S. Food and Drug Administration (FDA); and
- Proceeding with pre-clinical and clinical development activities in accordance with FDA protocols for submission to obtain approval for the particular product(s).
credit:420intel.com