The SIGMACEPTOR™-C program
Combating cancers: melanoma, prostate and pancreas

Scientific studies indicate that sigma-1 and sigma-2 receptor ligands can induce apoptosis (programmed cell death) and inhibit tumor growth. Through our SIGMACEPTOR™-C program, ANAVEX is leveraging these properties to develop new drug candidates with lead indications melanoma, prostate and pancreas.

ANAVEX has already screened about 30 novel compounds that show potent anti-cancer activity according to in vitro MCI standards (GI50, TGI or LC50). One compound in particular, ANAVEX 1007, has already been subjected to detailed in vivo xenograft studies and has shown high potency and replicability for prostate and melanoma xenografts (anti-proliferative, anti-metastatic and tumor growth inhibiting activity).

The major target indications addressed by the ANAVEX Oncology program are the following:

Melanoma

Melanoma is a malignant tumor of melanocytes which are found predominantly in skin but also in the bowel and the eye. It is one of the less common types of skin cancer but causes the majority of skin cancer related deaths. Malignant melanoma is a serious type of skin cancer. It is due to uncontrolled growth of pigment cells, called melanocytes. Despite many years of intensive laboratory and clinical research, the sole effective cure is surgical resection of the primary tumor before it achieves a Breslow thickness greater than 1 mm.

Melanoma is the deadliest form of skin cancer. According to a World Health Organization (WHO) report, about 48,000 melanoma related deaths occur worldwide per year. Malignant melanoma accounts for 75% of all deaths associated with skin cancer. In the United States, it occurs in about 69,000 patients each year and results in about 9,000 deaths. The number of melanoma cases worldwide is increasing faster than any other cancer.

The treatment includes surgical removal of the tumor, adjuvant treatment, chemo- and immunotherapy, or radiation therapy.

Prostate cancer

Prostate cancer is a form of cancer that develops in the prostate, a gland in the male reproductive system. The cancer cells may metastasize from the prostate to other parts of the body, particularly the bones and lymph nodes.

Rates of detection of prostate cancers vary widely across the world, with South and East Asia detecting less frequently than in Europe, and especially the United States.

Prostate cancer is a slow-growing form of the disease, with over 65% of men over the age of 70 estimated to carry microscopic evidence of the disease in their bodies. The growth in the number of cases of prostate cancer is expected to continue to be high in relation to other cancer types, with the market for treatments projected to reach $6.95 billion by 2015.

Neuropathic pain

Neuropathic pain is a complex, chronic pain state that usually is accompanied by tissue injury. With neuropathic pain, the nerve fibers themselves may be damaged, dysfunctional or injured. These damaged nerve fibers send incorrect signals to other pain centers. The impact of nerve fiber injury includes a change in nerve function both at the site of injury and areas around the injury.

Neuropathic pain is common in cancer as a direct result of cancer on peripheral nerves (e.g. compression by a tumor), or as a side effect of chemotherapy, radiation injury or surgery.

GlobalData estimated the global neuropathic pain to grow at a Compound Annual Growth Rate (CAGR) of approximately 4.3% from $4.8 billion in 2008 to $6.5 billion in 2015. This growth will be supported by the increase in the aging population, increased treatment seeking behaviour and increased uptake of the current products. The diagnosis rate remains as one of the barriers for the growth of the market. The available treatment options are moderately successful in meeting the market demand. There is still a need for better therapy and there exists unmet needs. There exists a market potential for any new entrant that will cater for these unmet needs. There is enormous opportunity for any drug that could match or better the efficacy provided by the current players with increased safety.

Pancreatic cancer

Pancreatic cancer is a malignant neoplasm of the pancreas. In the United States, c. 0.043 million individuals are diagnosed with this condition each year and 0.035 million die from the disease. The prognosis is in general poor as less than 5% of those diagnosed live for more than five years after diagnosis. Complete remission is still extremely rare. About 95% of exocrine pancreatic cancers are adenocarcinomas. The remaining 5% include adenosquamous carcinomas, squamous cell carcinomas, and giant cell carcinomas. Exocrine pancreatic cancers are far more common than endocrine pancreatic cancers (islet cell carcinomas), which make up about 1% of total cases.