Logiq Inc (LGIQ)

[4Godnwv]

SinoBiomed currently has four products in clinical trials.

Recombinant Malaria Vaccine
Recombinant Batroxobin (rBAT)
Recombinant Human Stem Cell Factor (SCF)
Ethelphazine

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 State Food and Drug Administration (SFDA), which has a drug approval process similar to that of the US FDA, has approved PfCP2.9 for Phase II Clinical Trial to be conducted in Ghana in summer 2007.

Phase I 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 receiving support from:

The Malaria Vaccine Initiative (MVI / www.malariavaccine.org) of the Program for Appropriate Technology in Health (PATH / www.path.org). PATH/MVI is funding clinical trials for the malaria vaccine that SinoBiomed has exclusive rights to develop. The PATH/MVI-SinoBiomed partnership focuses 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.

Recombinant Batroxobin (rBAT)

The world’s first batroxobin synthesized through gene recombination, prevents and treats surgical bleeding. Natural
batroxobin, extracted from snake venom, is the world’s most prescribed biological anti-bleeding agent, but also has a high production cost and safety concerns. A patent-applied-for bio-product, rBAT is in Phase II Clinical Trial.

Recombinant Human Stem Cell Factor (SCF)

A patent-applied-for bio-product in Phase 1 Clinical Trial that facilitates recovery of blood cell regeneration following radio-chemotherapy treatment in patients with malignant tumors.

Ethelphazine

A patent-applied-for anti-tumor drug entering Phase III Clinical Trial in fall 2006. Ethelphazine has wide-spectrum
anti-tumor activity, high potency, low toxicity and chemical stability. Patented in China, it is now in Phase III clinical
trial and expected to enter the market by the end of 2007. In the Phase II clinical trial of Ethelphazine, 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.

Market Analysis

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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