We have three items of great newsworthiness this month. The first is this: Welichem is about to start our Phase I clinical trials on our anti-psoriasis compound -- a milestone for any up and coming biotech company. We thus think it's timely to look at the stages that all biotech companies face before they can take a successful drug to the marketplace, and we do so after delivering this second exciting item:
We closed our $ 1,000,000 private placement in June. The funds will be used for continuing R & D and other operations. And our third exciting news is this:
We are delighted to welcome an excellent addition to our management team: Dr. Yan Chen. Dr. Chen obtained her Ph.D. in Neuroscience from the University of Kentucky and her MBA from Queen's University. Dr. Chen has more than ten years of pharmaceutical industry R&D experience, and has been involved in clinical trials associated with multinational biotech corporations. Dr. Chen was co-author of successful multimillion-dollar grant applications.
Here at Welichem, Dr. Chen will work closely with senior management to develop and execute the Company's strategic business plan, help coordinate internal and external communications, and help to explore new opportunities with a global perspective.
As to our newly commencing Phase I clinical trials, any life science company in its drug development process encounters three main areas of focus: Clinical tests and regulations, Manufacturing and marketing, and, of course, Investment (financing required for R & D activities and clinical development).
Basic research from the discovery phase is usually carried out in academic or small private labs, or within large pharmaceutical companies. The research may lead to the pre-clinical development stage, which must show safety data and a capacity for producing a desired result, or in other words, efficacy. This month we are looking at the first area of focus, in particular Clinical Development.
Clinical Development starts with a submission to a regulatory agency. In Canada the submission application is called a Clinical Trials Application (CTA), which is submitted to Health Canada. In the USA the equivalent documentation is called an Investigational New Drug (IND) Application. The IND is submitted to the Food and Drug Administration (FDA), an agency within the United States Department of Health and Human Services. Submissions must also be made to the Institutional Review Board (IRB) in the USA and the Research Ethics Board (REB) in Canada; these are independent bodies of medical, scientific and public community members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial. Once approval has been granted, Phase I clinical trials can begin.
What exactly is Phase I?
Phase I trials are the first-stage of testing on human subjects. The main concern during Phase I trials is the safety of the drug when applied to human beings. Phase I trials usually involve between 30-70 volunteers who are carefully screened, and paid for their participation. The trials are usually conducted at in-patient clinics under the supervision of a qualified physician.
Phase I trials usually focus on safety in subjecting patients to a range of doses of the drug candidate. Phase II trials focus on efficacy, or the realisation of therapeutic results. Because Welichem's candidtate is a topical preparation, both safety and efficacy will be studied in our Phase I trial.
If our results are favourable, as we anticipate, we look forward to commencing Phase II testing in early 2008.
Preliminary data from the Phase 1 Clinical Trials should be available by the end of December. We will definitely keep you informed of new developments.
Enjoy your summer.
July 2007
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