The lead drug, AP-001, is expected to be tested in Phase I clinical trial in the second half of 2018.
The burden of pancreatic ductal adenocarcinoma (PDAC) is enormous. Worldwide, the number of new cases was 338,000 and the number of deaths was 330,378 in 2012. The number of deaths per year nearly equals the number of new cases highlighting the lethality of this disease. Pancreatic cancer was the 12th most common type of cancer in the US, representing just 2.8% of all new cancer cases. Despite this, pancreatic cancer was the 4th most common cause of cancer-related death. Furthermore, the incidence of pancreatic cancer is increasing. By 2030, authorities’ project that pancreatic cancer will become the 2nd leading cause of cancer-related death in the US after lung cancer.
Only 20% of pancreatic cancer patients are alive one year after diagnosis and only 7% are expected to be alive five years after diagnosis.
Our Technology Approach
Surgical resection remains the only definitive treatment for PDAC, and the only treatment that offers a chance for a cure. Unfortunately, only approximately 10-20% of patients will have tumors that are amenable to surgery. For patients that have undergone surgery, adjuvant chemotherapy is given postoperatively and has been shown to impart a survival advantage when compared to surgery alone but only improved the survival benefit by a few months.
Our research and that of other renowned researchers has shown that a strong correlation exists between the over expression of a metabolic enzyme called glycogen synthase kinase 3 beta (“GSK3β”) and cancer progression in humans. Activation of GSK3β up-regulates the rapid growth of cancer cells and increases the resistance to natural cell death in cancer cells. In addition, research studies have shown that histone deacetylase (HDAC) is over expressed in cancer cells and that it stimulates the conversion of cancer cells to ones that are more likely to invade surrounding normal tissue and metastasize. This conversion, via the HDAC pathway, makes the cancer cells more resistant to chemotherapy and radiation.
Our lead compound, AP-001, is novel dual inhibitor compound that inhibits both the enzyme histone deacetylase and GSK3β. We anticipate that AP-001 will be used in conjunction with chemotherapy to make it substantially more effective and, based on our clinical studies, may be used as a maintenance therapy to keep the cancer from reoccurring.
While our initial target is pancreatic cancer, we will be also testing AP-001 in other cancers including liver cancer.
Small molecules developed by Avenzoar target multiple pro-cancer pathways at the same time.
The lead drug AP-001 is expected to be tested in clinical trial as soon as in late 2018. The drug will be first tested in pancreatic cancer patients.
Professional Scientific and administrative teams work together to carry projects to the clinical trial stages and to FDA approval.
A recent article about AP-001 was published on May 24, 2016, by Alice Goodman in pm360, specialized in Medical News. Title of the article: Novel Drug Shows Preclinical Success in Pancreatic Cancer. Please click (or copy/paste) the link below to read:
Listen to Dr. Stephen Pandol and Terrance Bruggeman talk about their stellar work and progress on their research regarding a cure to pancreatic cancer at a National Pancreas Foundation event on October 26, 2016:
Avenzoar Pharmaceuticals has an exclusive license of the patent application and technical information related to AP-001 and other novel chemical entities, from the Cedars-Sinai Medical Center in Los Angeles, CA. This license will give the Company worldwide exclusive rights for the prevention and treatment of diseases in humans.
In July 2016, the United States Food and Drug Administration (FDA) has granted the orphan drug status to AP-001. Avenzoar has filled a similar application with the European Medicine Agency.
Avenzoar specializes in developing small molecule therapeutics for cancer diseases. This approach permits targeting multiple pro-cancer targets at the same time while decreasing toxic side effects.