Product development
RDI´s Technology platform
The proprietary technology platform utilizes a new benzene polycarboxylic acids compound, which is prepared by alkaline oxidation of hydrolyzed lignin, used as part of a composite substance, where the composite substance is prepared by complexing the new benzene polycarboxylic acid compounds with a metal cation. The water-soluble polymer of benzene polycarboxylic acids exhibits its own biological effect.
Chemical properties of the new water-soluble polymer compound of benzene polycarboxylic acids make it possible to obtain a broad range of highly stable complexes, as well as pharmaceutical, nutraceutical and cosmetic compositions for parenteral, enteral and topical administration to human beings and animals.
BP-C1 - Medical oncology
BP-C1 – Novel Cancer Drug With Low Toxicity
Cancer is one of the leading causes of death worldwide with a continuous growth.
Despite progresses made with targeted therapeutics and personalized treatments, WHO predicts 24.1 million new cancer cases and 13.0 million cancer–related deaths by 2030.
Available cancer drugs walk a fine line between efficiently killing cancer cells and leaving normal cells unharmed (MTD paradigm).
Most cancer drugs induce severe dose-limiting side effects like neurotoxicity, neutropenia, nausea, and vomiting, that greatly affect the well-being of the patients and often have a negative impact on the outcome of the treatment.
There is an obvious need for efficient anti-cancer drugs with better toxicity profiles.
BP-C1, RDI´s lead product, is an anti-neoplastic agent with palliative properties and is based on Meabco’s patented polyphenolic technology platform.BP-C1 is positioned for the global USD 107 billion market of cancer treatment and palliation drugs. The first step is to approach the breast and pancreatic segment of this market, which accounts for 14% of all cancer types and valued at USD 12.3 billion in 2013.
BP-C1 offers a combination of immunomodulation and tumor control in one product. Usually, immunomodulation and tumor control are treated separately and by using two or more drugs.
BP-C1 has been tested in a wide range of animal trials as well as in human clinical trials together demonstrating a high safety profile together with very low toxicity. BP-C1 acts strongly apoptotic, anti-proliferative and anti-angiogenic on tumor cells, while at the same time contributing to anti-cancer immune regulatory activities.
Clinical Research
BP-C1 has been tested in close to 300 breast and pancreatic cancer patients in seven countries with promising results. It is noteworthy, that more than 80% of breast cancer patients and more than 60% of pancreatic cancer patients responded to the therapy. BP-C1 is aimed at fighting the cancer combined with strengthening the body’s immune system. Our research has shown that:
- BP-C1 had very low toxicity.
- BP-C1 significantly reducing tumor growth.
- BP-C1 significantly increased the quality of life.
- BP-C1 treatment can be given as an intramuscular injection permitting treatment in a local clinic or in the patient’s own home.
Treatment Of Incurable Pancreatic Cancer
In a new single center study of patients treated with BP-C1 for 32 days, 75% obtained stable disease, the quality of life improved and the toxicity was low, frequency of mainly mild side effect, and significant increased Quality of Life.
A randomized trial of BP-C1 in pancreatic cancer is well underway.
Treatment Of Metastatic Breast Cancer
The outcome of BP-C1 treatment has been investigated in several studies, most recently completed two randomized double-blinded placebo-controlled studies in metastatic breast cancer patients who have not responded to previous conventional treatments and who had limited options for further treatment. The results show that:
- BP-C1 had a significant effect compared to placebo on tumor growth
- Response rates, including SD, ranging from 85% to 93% (RECIST)
- BP-C1 had the best efficacy in Triple Negative patients
- BP-C1 had very low toxicity
- No neutropenia or other adverse events detected
- Only mild to moderate transient side effects
- Quality of Life was sustained
- Treatment was well tolerated
- BP-C1 could be safely administered for more than 64 days
- Treatment can easily be given in the patients’ own home or at a nearby clinic.
BP-C2 - nuclear radiation protector
BP-C2 MEDICAL COUNTERMEASURE (MCM)
BP-C2 is a complex of ammonium molybdate and a lignin-derived polymer of benzene polycarboxylic acids (worldwide patents valid until 2033) developed for treatment of radiation-induced side effects in cancer patients and as a medical countermeasure (MCM) for acute cutaneous and gastrointestinal radiation syndromes (multi-year contracts with US Government Agencies).
As a MCM agent, BP-C2 is being tested as a radioprotector and radiomitigator of health effects from chronic exposures to ionizing radiation (military personnel, nuclear industry workers, astronauts, and medical personnel).
BP-C2 is effective when administered orally or topically before or after exposure to radiation, manufactured ready-for-use and is stable at room temperature for at least 2 years.
Oral BP-C2 has demonstrated radiomitigative activity in murine models of hematopoietic and gastrointestinal acute radiation syndromes (H- and GI-ARS). The development of BP-C2 for GI-ARS is carried out under a PDSS contract with NIAID/NIH (studies in rodents performed by SRI International, CA, USA) and development of topical BP-C2 for cutaneous radiation injury (CRI-ARS) is carried out under a multi-year contract with NIAID (studies performed in large animals by Lovelace Biomedical, ABQ, USA).
