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Sinobiomed currently has four products in clinical trials.
Recombinant Malaria Vaccine
Sinobiomed’s malaria candidate vaccine (PfCP2.9) targets the world’s most deadly malaria parasite (Plasmodium falciparum) at its most destructive stage—its rapid replication in human red blood cells. In the now completed Phase I Clinical Trial, PfCP2.9 showed greater immunogenicity and fewer adverse reactions than other malaria candidate vaccines overseas.
The Chinese government funding grant of RMB 9 million (US$1.24 million) announced in January 2008 will support the continued clinical trial of Sinobiomed’s recombinant malaria vaccine and advance its development with partner SMMU.
The grant from China’s Ministry of Science and Technology, awarded jointly to Shanghai Wanxing and SMMU, is part of the key “863 Program” to support technology development as part of the government’s 11th five-year plan. Two-thirds of the fund will support Shanghai Wanxing’s planned Phase II Clinical Trial of the patented PfCP2.9 vaccine to be conducted in epidemic areas. The current research schedule calls for the application to the Chinese Food and Drug Administration (SFDA) for the Phase II Clinical trial in malaria endemic areas to be submitted by end of 2008.
The balance of the fund will support the joint development by Shanghai Wanxing and SMMU of a multistage, multivalent vaccine based on PfCP2.9. The multistage, multivalent vaccine, which seeks to improve immunogenicity and extend the immune period, is expected to enter into clinical trials in 2009.
Phase I PfCP2.9 Clinical Trial Summary
The goal for PfCP2.9 is to create a blood stage vaccine (asexual stage). The vaccine aims to reduce the parasite densities in the blood and could be able to reduce the morbidity and mortality of the malaria in infants and children. The goal of the trial was to assess the vaccine’s safety and conduct a preliminary evaluation of its immunogenicity. A total of 52 volunteers were enrolled; 40 of them received the vaccine and 12 received a placebo. The trial was a dose escalation, placebo controlled (ISA 720 adjuvant) study. Each volunteer received three intramuscular injections with 0.5 ml per injection.
The results of WAN/Mal-001 showed:
- No vaccine related severe adverse events
- Mostly mild or moderate local adverse events
- Mid-high antibody titers generated in four dose groups
- No dose response effects were observed.
The Phase I Clinical Trial took place from August 2003 to October 2004 at the Shanghai Changhai Hospital. Sponsored by Wanxing Bio-Pharmaceuticals, Sinobiomed’s Chinese subsidiary, the trial was funded by the World Health Organization (WHO), with the protocol reviewed and approved by WHO’s Ethics Committee.
Support for Vaccine Development
The Company’s development of the recombinant malaria blood-stage vaccine is received support from:
- The Malaria Vaccine Initiative (MVI / www.malariavaccine.org) of the Program for Appropriate Technology in Health (PATH / www.path.org). PATH/MVI helped fund Phase I Clinical Trial for the malaria vaccine that Sinobiomed has exclusive rights to develop. The PATH/MVI-Sinobiomed partnership focused on improving the manufacturing process as part of the vaccine’s safety evaluation, a critical step in the clinical development plan to generate proof that PfCP2.9) can impact the parasite in children.
- The World Health Organization (WHO / www.who.int) is promoting collaboration among public and private organizations in malaria vaccine development through its Initiative for Vaccine Research (IVR / www.who.int/vaccine_research/en/). The WHO/IVR has signed a memorandum of understanding with Sinobiomed to collaborate on the vaccine’s development and worldwide distribution.
- The Bill & Melinda Gates Foundation, which to date has donated $257.6 million to PATH/MVI.
Malaria: A Global Disease
Malaria threatens more than 2 billion people globally and kills more than a million people a year – most of them children. In Africa, malaria causes the death of a child every 30 seconds. The most important tropical disease, malaria remains widespread throughout the tropics, but also occurs in many temperate regions. It exacts a heavy toll of illness and death, especially among children and pregnant women. It also poses a risk to travelers and immigrants, with imported cases increasing in non-endemic areas. Treatment and control have become more difficult with the spread of drug-resistant strains of parasites and insecticide-resistant strains of mosquito vectors. Malaria exists in 100 countries but is mainly confined to poorer tropical areas of Africa, Asia and Latin America. More than 90% of malaria cases and the great majority of malaria deaths occur in tropical Africa.
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Recombinant Batroxobin (rBAT)
The world’s first batroxobin synthesized through gene recombination in a yeast expression system, rBAT prevents and treats surgical bleeding. Native batroxobin, extracted from pit viper venom, is world’s most prescribed biological anti-bleeding agent. Since rBAT is produced through genetic engineering, it reduces the risk of biological contamination and neurotoxicity that have been associated with native batroxobin. Besides testing rBAT’s effectiveness in surgical applications, Sinobiomed is also researching and developing an anti-bleeding kit for use in emergency situations, such as traffic accidents and combat. Patented in China, rBAT is expected to complete Phase IIb Clinical Trial in February 2008.
Phase IIa Clinical Trial Summary
The results of Phase IIa, the first of two steps in the Phase II Clinical Trial, showed that rBat is both safe and efficacious in reducing both the amount of bleeding and bleeding time during surgery. The double-blind, randomized, placebo-controlled Phase IIa Clinical Trial was conducted from December 2006 to August 2007 in five Chinese hospitals: Shanghai Changhai, Shanghai Huadong, Shanghai Huashan and Suzhou University’s two affiliated hospitals. Phase IIa had three objectives: to observe rBat’s anti-bleeding effect of rBat on surgical incision by intravenous injection compared to placebo; to select an optimal dose for Phase IIb trial; and to further observe rBat’s safety in clinical use. 119 volunteers were enrolled into the study.
A dose of 2KU rBat was selected for use in Phase IIb and Phase III Clinical Trials. In the Phase IIb trial surgical bleeding and bleeding not associated with surgery are being treated with rBat via intramuscular injection or intramuscular/ intravenous injection together. The trial was designed to observe the anti-bleeding effect of different routes of administration on surgical and non-surgical bleeding. Phase IIb is expected to be completed in February 2008.
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Recombinant Human Stem Cell Factor (SCF)
A patent-applied-for bio-product in Phase 1 Clinical Trial, rh-SCF facilitates recovery of blood cell regeneration following radio-chemotherapy treatment in patients with malignant tumors. The estimated market launch date is December 2010.
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EtheOphazine
A Chinese patented anti-tumor drug, Etheophazine, entered Phase III Clinical Trial in fall 2006 and is expected to enter the market in April 2009. Etheophazine has wide-spectrum anti-tumor activity, high potency, low toxicity and chemical stability. In the Phase II clinical trial of Etheophazine, clinical indications have been expanded to lung cancer and malignant tumors of gastrointestinal tract besides malignant lymphoma. The incidence of malignant lymphoma ranks 9th to 11th among all tumors and is increasing each year. In China, there are 25,000 new cases of malignant lymphoma each year. There are about 480,000 lung cancer cases, i.e. 16% of all tumors cases in China, and the incidence of lung cancer is increasing each year.
Cancer is now the leading cause of death in China. An estimated 6.3 million people die from cancer each year and the figure may double by 2020. The total annual sale of anti-tumor drugs in China is currently $1 billion and the market capacity for anti-tumor drugs is to grow by 17% to 20% in the next few years. There are about 1.6 million new tumor patients every year in addition to the 1.4 million patients under treatment.
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