ViroMed has two main areas of focus: DNA/protein-based biopharmaceuticals and phytotherapeutics (botanical drugs/nutraceuticals). ViroMed now has five main products in its pipeline targeting cardiovascular disease, cancer, and immune-related disorder, with clinical trials in the US, Korea, and China.
VM202 – Therapeutic Angiogenesis
VM202 is a DNA-based medicine to treat ischemic cardiovascular diseases via therapeutic angiogenesis. It is designed to express isoforms of hepatocyte growth factor (HGF) for the treatment of coronary artery disease (VM202-CAD) and peripheral artery disease (VM202-PAD) by the formation of new blood vessels when injected into the ischemic sites. These new collateral vessels will increase blood flow and tissue perfusion, thereby effectively treating ischemia.
VM202 has also been shown to stimulate the growth and regeneration of nerve cells. Therefore, it is also being developed for the treatment of diabetic neuropathy (VM202-DPN), a common complication of type 2 diabetes mellitus that usually manifests itself as a disease affecting the nerves in the leg, causing intense pain and difficulty in movement.
Evidence of VM202’s superior therapeutic effect has been shown through studies that compare its effectiveness against competitors’ products in new blood vessel creation in various kinds of animal models. The findings have been published in international medical journals such as AJP – Heart and Circulatory Physiology (295): H522-532, 2008 and Radiology (249):1-2, 107-118, 2008 by a University of California, San Francisco (UCSF) research team.
VM202 is under clinical development in the US, Korea, and China. In March 2008 ViroMed entered into a co-development with Biologics Delivery Systems Group (BDS) of Cordis Corporation, a Johnson & Johnson Company, which will evaluate the efficacy of VM202 for treatment of coronary artery disease using BDS’ NOGA® Cardiac Navigation System and the MyostarTM injection catheter.
Critical Limb Ischemia
Phase II (completed IND application)
Beijing Northland Biotech
Chronic Refractory Myocardial Ischemia
Phase I/II (IND approved)
BDS of Cordis Corp. (a Johnson & Johnson company)
Phase I completed
Diabetic Peripheral Neuropathy
VM501 – Protein Therapeutic for Thrombocytopenia
VM501 is a re-engineered form of interleukin 11 (IL-11) targeting chemotherapy-induced thrombocytopenia (CIT). It has been shown to induce an increase in the number of blood platelets. In the Phase I and Phase II clinical trials performed in China, it showed significant therapeutic effects without severe adverse events.
Thrombocytopenia is described as an abnormally low presence of blood platelets. CIT occurs in cancer patients following chemotherapy. The only currently available treatments are platelet transfusion (which is dependent on availability) and the administration of Neumega (marketed by Wyeth), a recombinant IL-11 protein that is the only FDA-approved drug for the disease. However, due to the modest therapeutic activity and severe side effects, its use is limited and has only managed to attain a fraction of the total CIT market. In contrast, VM501 is more effective in low doses and shows less toxicity compared with Neumega. This is expected to allow VM501 to capture a significant share of the CIT market.
The Phase IIb clinical trial has been completed in China. The IND for the Phase III trial was submitted to the SFDA and is awaiting approval.
PEG-VM501 is the PEGylated version of VM501 that improves upon VM501’s biopharmaceutical properties. Pre-clinical studies in primates have demonstrated that this form of VM501 shows greatly improved pharmacodynamic and pharmacokinetic features.
Phase III (IND submitted)
Beijing Northland Biotech
VM206 – Therapeutic Cancer Vaccine
VM206 is a therapeutic cancer vaccine that has potential applications for breast, ovarian, and pancreatic cancers. The product induces an immune response against the tumor-associated antigen Her2/neu, which is found in high levels in several types of cancer cells. The product consists of naked DNA and an adenovirus, which delivers the gene for truncated Her2/neu and cytokine GM-CSF as a genetic adjuvant. Pre-clinical studies have been completed and the efficacy data was published in the international journal Gene Therapy (2008, 15, 1351-1360). The product is being developed for injection directly into the muscle of patients who have received surgery and/or chemotherapy.
Preventive cancer vaccines such as Gardasil can prevent cancer from developing in healthy people. In contrast, therapeutic cancer vaccines such as VM206 can treat the already existing cancer while also preventing relapse and metastases. These effects are mediated by enhancing both humoral and cellular immune responses against cancers.
The Phase I IND application has been approved in Korea and the clinical trial is planned to start in 2011.