Cancers is one of the most lethal groups of diseases known to humankind. Statistics from the American Cancer Society has estimated that up to 7.6 million people have died in 2007 due to cancer and cancer-related symptoms. Abnormalities in genetic material are the major cause of cancer. Nearly all are caused by abnormalities either due to the effects of carcinogens, such as tobacco smoke, radiation, chemicals, or infectious agents, or randomly acquired through errors in DNA replication and inherited genes. Cancers are generally treatable, depending on its type, location and stage, and is usually treated with a combination of surgery, chemotherapy and radiotherapy upon discovery. Although cancers are commonly treatable, their prognosis are poor. Most specialists are now even questioning the use of chemotherapy since the quality of life versus survival is poor.

The EGF Cancer Vaccine (EGF-CV) has been stated to be one of the most promising products for the treatment of cancer. The vaccine has been lauded as possibly the world’s most effective cancer vaccine developed thus far, and is specific for patients with solid tumours, such as lung cancer, breast, bladder, head & neck, ovarian and prostate cancer. The mechanism of the EGF-CV lies in stimulating the body’s immune system to reduce the amount of EGF in the blood, thus causing cancerous tumors to slow down growth and in some instances stop growth. Clinical trials conducted thus far on patients with lung cancer, have shown that the EGF-CV increases survival rates significantly, while increasing quality of life compared to standard chemotherapy.

“I believe we were able to take advantage of the current socio-political situation to obtain the rights to the technology,” said Dato' Mukhriz bin Tun Mahathir. “Due to the sanctions being imposed on the country by the US, we were able to come in at the right time to offer our services, and help such cutting-edge technology from Cuba reach the outside market.”

“With our good relations with the Cuban government, we took the decision to stick our neck out on this,” added Johan. “We obtained the world rights to the vaccine and invested accordingly. For such a potential blockbuster product will allow us to take on the big pharma boys.”

Currently, Bioven owns the rights for the EGF-CV in South East Asia, European Union, Australia, New Zealand, Japan and OIC countries. While, Phase II clinical trials have been completed in Cuba with impeccable results, clinical trials have begun in Malaysia and Europe to justify its use. Bioven has been in collaboration with the Clinical Research Center (CRC) of the Ministry of Health and BiotechCorp in setting up the largest sets of clinical trials for a breakthrough product in the country on record.

According to CEO, Dr. Shermal Perera, both parties have responded to the project with great enthusiasm and gumption to see the trials through. Much support have been provided, and despite little experience in anything of this magnitude, both organisations have been equally big-sighted.

“They (BiotechCorp and CRC) have been very much gung-ho of our progress,” he quipped. “As pioneers in the field of clinical trials, the enthusiasm and support is overwhelming. We hope to establish ourselves as a model, as we have a point to prove in playing the game and getting ourselves going.”

“My role here in Malaysia, is in part, an assessor and an enabler,” she claims. “I am not involved as a part of Bioven, but as an external source provided the government in Havana with the task to guarantee patient rights and fine-tune the coordinations between the various parties involved (in the clinical trials).”

An important task indeed, as she goes around the country sharing her experiences with various oncologists and hospitals on Good Clinical Practices (GCP) in preparation for European clinical trial auditors. Despite the warm response from doctors in the country, Dr. Soraida believes that in certain hospitals there is a further need to GCP training in order to meet the international standards. However, she was very impressed with the medical competencies in Malaysia saying that it is of high standards..

“Despite the uphill task that we are facing, we can only strive forward, as we have a point to prove (to the world),” said Dato' Mukhriz. “We are sitting on a potential breakthrough, and are committed in establishing the country as a center for clinical trial research. Bioven is not too focused on searching for grants, though it may be a bonus. But we keep pushing on, as there is a need to, and hope it serves as a wake up call for the industry on our own potential.”

www.bioven.com.my