Pegasus Pharmaceuticals developed two botanical small-molecule products against cancer, the HemoMex solution (also known as PandiMex® in North America, Europe and Asia) and CanaQ capsules (also known as Careseng® SG2). After a series of clinical trials at the National Cancer Center of Republic of Georgia in accordance with the strict GCP standard used internationally, HemoMex and CanaQ were proven to be safe and effective. On Nov 17, 2008, the two products had past the evaluation of the Ministry of Health, Republic of Georgia and were approved as oncology prescription drugs. At the same time, Pegasus’ other two oral products, the Lipo-Aid (also known as Careseng® MK) and Cardio Guard (also known as Bioseng® #1) were approved as cardiovascular non-prescription OTC drugs.
The National Cancer Center of Republic of Georgia is a national large-scale oncology center. After the Soviet Union was dissolved, it remains to be the most influential and largest oncology center in the Caucasus region and among all the CIS countries (former Soviet Union). Since several years ago, Pegasus Pharmaceuticals Group had established a long-term collaborative partnership with the National Cancer Center of the Republic of Georgia and collected a large amount of clinical data.
The HemoMex injection can help inhibit the bone marrow suppression caused by chemotherapy (increase the white blood cell count). Chemotherapy is widely used in most cancer treatments. About 30-40% of cancer patients (annual average total of 25 million cancer patients globally, including new cases) have impaired immune system with bone marrow suppression caused by chemotherapy.
Currently most inhibitors of bone marrow suppression are genetically engineered drugs. However, these drugs are known for many shortcomings. For example, there is higher requirement for patient’s health condition before taking these drugs; these drugs are highly toxic with single function of only helping increase the white blood cell count. More importantly, these inhibitors must be used when white blood cell counts are lower than normal, otherwise may cause excessive white blood cells or even lead to leukemia.
Clinical studies at the National Cancer Center of Republic of Georgia have shown that Pegasus’ HemoMex injection containing the novel botanical small-molecule compound active ingredients can help inhibit bone marrow suppression. In contrast with the current genetically engineered inhibitors, the effectiveness of HemoMex lasts longer but without much toxicity. Enrollment criteria of patients are much less strict. Furthermore, HemoMex helps improve quality of life of patients at a comparatively much lower cost than the current inhibitors. Most importantly, HemoMex is a multi-functional inhibitor which can help enhance the immune system of patients and can be used routinely in combination with chemotherapy.
CanaQ can help enhance the efficacy of conventional radio- and chemotherapy, as well as lowering toxicity of these conventional treatments. Studies have shown that the multi-drug resistance is the biggest obstacle of chemotherapeutic drugs. Although from some in vitro experiments and clinical studies, some chemical drugs have shown to reverse drug resistance, but due to being highly toxic, they can not be used on patients. This is the reason why the U.S. FDA still has not yet approved any synthetic drug resistance reversal agent. CanaQ is a non-toxic drug resistance reversal agent without any competitor among the synthetic drugs or among the botanical drugs in the present.
Pegasus Pharmaceuticals is foreseeing a huge market potential for these two novel anti-cancer drugs. In 2008, the global sales of genetically engineered inhibitors for bone marrow suppression are nearly 50 billion U.S. dollars. As an inhibitor which can also enhance the immune system, HemoMex can be used before or throughout the course of chemotherapy for bone marrow protection. In the future, the market of HemoMex will be expanded from just “Bone Marrow Protection” to include “Restoring Bone Marrow from Suppression”. These two novel drugs can work synergistically with most types of chemotherapeutic drugs to enhance their efficacy and lower toxicity (multi-drug resistance reversal and organ protection) and as a result improve the patients’ level of tolerance to chemotherapy.
The approval of HemoMex and CanaQ as novel oncology prescription drugs in the Republic of Georgia marks an important milestone in the drug development of Pegasus Pharmaceuticals Group Inc. It’s a stepping stone for the drug applications ongoing in the CIS countries including Ukraine, Armenia, Moldova, and Uzbekistan, which are expected to be approved very soon, as well as for preparing the drug applications to the U.S. FDA and EMEA of European Union. Pegasus had successfully developed the oral dosage form of HemoMex. Being similar to HemoMex in terms of efficacy but more convenient in application, the oral form is expected to have larger market potential. Pegasus had decided to file drug application to the U.S. FDA and EMEA for the oral dosage form of HemoMex and is expected to obtain approval by 2013 for sales. As the next step, Pegasus is planning to file drug application for the multi-drug resistance reversal agent, which is expected to be approved and launched in market by 2017.
Figure 1. Mr. James Jingtao Cao, General Manager, Pegasus Pharmaceuticals Group Inc. (left); Dr. Sherman Shumin Zhao, Clinical Project Manager, Pegasus Pharmaceuticals Group Inc. (right); Dr. Razo Gagua, Professor, General Director of the National Cancer Center, Republic of Georgia (middle).
Figure 2. Mr. James Jingtao Cao and Dr. Sherman Shumin Zhao, General Manager and Clinical Project Manager of Pegasus Pharmaceuticals Group Inc. are discussing about clinical trial protocols with medical doctors from the National Cancer Center, Republic of Georgia.
Figure 3. One of the patients enrolled in the clinical trial of "PandiMex as Inhibitor of Bone Marrow Suppression Induced by Radio- and Chemotherapy".
