After a series of clinical trials conducted in accordance with the international GCP standard, the two botanical small-molecule compound anti-cancer drugs developed by Pegasus Pharmaceuticals Group Inc., HemoMexI (also known as PandiMex®) injection, HemoMexS (also known as Careseng® SG2) oral dosage form had been proven the safety and efficacy in clinical cancer treatment.  On Nov. 17, 2008, the Ministry of Health of Republic of Georgia approved the two products as oncology prescription drugs for conventional cancer treatment. (HemoMexI was originally approved under the drug name of “HemoMex”, whereas HemoMexS was originally approved under the drug name of “CanaQ”.  In order to unify all the names of drugs developed, Pegasus had submitted applications to the Ministry of Health of Republic of Georgia for name change of these two drugs.  On Sept. 28, 2009, Pegasus received the novel drug certificates for these two drugs under the new names).

With higher efficacy in integrative therapy than the current genetically engineered drugs (e.g. G-CSF), HemoMexI injection helps inhibit bone marrow suppression caused by chemotherapy (increase white blood cell count).  On the other hand, HemoMexS can be used in combination with most types of chemotherapeutic drugs to not only enhance their efficacy but also lower the toxicity of chemotherapy.

The approval of HemoMexI and HemoMexS as novel oncology prescription drugs in the Republic of Georgia marks an important milestone in the drug development of Pegasus Pharmaceuticals Group Inc.  The company had successfully developed the oral dosage form of HemoMexC.  Being similar to HemoMexI 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 HemoMexC and is expected to obtain approval by 2013 for sales.  In 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.

• Join meeting of Scientific Board of National Cancer Centre and Georgian Society of Medical Oncologists - Extract from the minutes.

• HemoMexI Registration Certificate

• HemoMexS Registration Certificate