This new class of therapeutics is based on the combination of metal ions of known therapeutic potential with a novel proprietary pharmaceutical ingredient, BP. BP-C1 consists of BP combined with platinum.
The researchers believe that these therapeutics could have benefits for patients suffering other types of cancer. So much so that the breast cancer trials will be followed by clinical trials of other cancer indications, where preliminary positive patient results already exist.
After obtaining results from clinical Phase I/II trials of its anti-cancer drug BP-C1 with patients in Denmark, Meabco A/S will now continue with further clinical trials.
BP-C1 has been tested in clinical trials on breast cancer patients with advanced cancer (mainly phase IV).
The trials have confirmed, that the use of BP-C1 on patients with this type of cancer has good effect with very few, mild, transient adverse side effects.
BP-C1 is to be administered as an intramuscular injection. The treatment period is approximately one month, and patients are normally not hospitalised.
"The company has developed a very interesting product-portfolio in the field of cancer treatment and the breast cancer clinical trials will soon be complemented with additional initiatives in the treatment of cancer diseases," said Stig Lofberg, managing director of Meabco A/S.
BP-C1 combines the effectiveness of known anti-neoplastic platinum compounds with the beneficial effects of beta-endorphin release, while significantly reducing the known side effects of traditional platinum-based drugs.
BP-C1 is a combination product consisting of BP and platinum salts. In BP-C1 (BP and platinum), BP forms a chelate with the platinum salt.
Platinum compounds are well known anti-cancer drugs used for the treatment of many cancers such as breast cancer, gastrointestinal cancer, lung cancer, ovarian cancer, testicular cancer, as well as malignant melanoma.
Despite the selective targeting of cancer cells, traditional platinum-based drugs suffer from significant side effects such as nausea, nephrotoxicity (resulting in kidney impairment), ototoxicity (resulting in permanent hearing impairment), and moderate myeloid suppression (affecting the cells of the blood and immune system). These side effects are of great concern when using the drugs.
In June 2006 the Danish Medicine Agency gave permission for the continuation of the clinical trials of BP-C1.
The phase IIB clinical trials will include patients with advanced breast cancer and will be conducted as a series of randomised, placebo-controlled, double blind tests - the so-called confirmative trials.
BP-C1 will only be available in connection with the planned controlled trials, which are designed with the aim of obtaining a confirmative efficacy and safety profile.
On conclusion of the clinical trials all data will be filed with the Danish health authorities (the regulatory authorities) in order to obtain marketing approval for the drug.