Research

Pharmagenesis’ mission is to create value-added products based on the bioactive Natural Products found in Traditional Chinese Medicines (TCM).  The following diagram describes the process used by Pharmagenesis in its discovery program as well as the types of pharmaceutical products that are generated: 



Natural Products

Natural products have been a source of drugs and drug leads for decades. According to scientists at the US National Cancer Institute, 61% of the 877 small-molecule new chemical entities (NCEs) introduced as drugs worldwide during 1981–2002 are related to natural products.[1]  The natural product related NCEs include natural products (6%), natural product derivatives (27%), synthetic compounds with natural-product-derived pharmacophores (5%), and synthetic compounds designed on the basis of knowledge gained from a natural product (that is, a natural product mimic; 23%).

If specific therapeutic areas are examined, the percentages are higher.  For example, 74% of anticancer compounds are natural products or have been derived from, or inspired by, a natural product.

Traditional Chinese Medicines (TCM)

The Company believes that by focusing its research on TCM's which have been used effectively and safely for millenna, there is a significant likelihood of finding new safe and effective therapeutic products.  The number of products already derived from that source supports this view.

The TCM tradition is a rich one that spans over 4,000 years of use. Herbal medicine has historically been an integral part of Chinese culture and medical practice.  Descriptions of herbal therapy occur in the earliest texts that discuss medical practice in China.  Manuscripts from tombs excavated in Hunan dating to 168 BC describe therapeutic combinations of different herbs.[2]  This tradition continues today and China is making a drive to modernize its traditional medicines.  The Pharmagenesis, Inc. strategy fits perfectly with the Chinese policy.

Currently in China, there are 360,000 doctors specializing in TCM, over 2,000 specialized hospitals, 28 colleges of TCM, as well as 57 research institutes devoted to TCM.[3]  Also, virtually all hospitals that specialize in Western medicine have departments of TCM.

Cell systems

Pharmagenesis has selected the cell systems responsible for immune responses and generation of blood cells as its initial research focus. 

Clinical situations where suppression or stimulation of these systems is important are areas of high medical need and, as such, represent significant economic opportunity.  This is especially true since in many cases the problems are chronic in nature and require long-term therapy.  Importantly, TCM's are frequently used to treat disease conditions by modulation (stimulation or suppression) of the immune system or the blood forming cells in order to restore "balance".

Using reliable in vitro and in vivo models, Pharmagenesis, Inc. is able to quickly validate those TCM’s which are of highest value in treating these disorders, and to identify those bioactive substances in the selected TCM’s which have the greatest potential for development into new therapeutic products.

The identification of product candidates from TCM's involves the isolation of highly-purified active fractions and verification of their bioactivity in vivo, and subsequently, in clinical studies.


Phytopharmaceuticals today

Natural sources such as microorganisms or plants have long been an important source of drug products.  All antibiotics are derived from microorganisms found in nature and have had an impact that has been enormously beneficial from both a medical and economic perspective.  Insects and plants have also yielded important therapeutic substances.

Pilocarpine, an important ophthalmic product for treating glaucoma, originates from a plant, as does the anticholinergic, atropine.

The antimalarial drug quinine is plant derived, as is theophylline, the asthma drug.  The once standard cardiovascular medicines digoxin and reserpine originated from plants, as did the important anticancer drugs vincristine and vinblastine.

Among many others, the most prominent recent example is the drug Taxol, which was initially isolated from the bark of a Yew tree growing in the Pacific Northwest.  It is a life-saving drug that is effective in treating certain resistant cancers, notably ovarian cancer.

With thousands of plants in the Chinese Pharmacopoeia, Pharmagenesis, Inc. believes that there is an enormous reservoir of bioactive molecules with a history of human use that can be developed, either as new chemical entities or as mixtures, into new products worldwide and/or as new drugs under Chinese State Drug Administration Regulations.

Patent strategy and Technology

Pharmagenesis currently isolates low molecular weight (LMW) compounds from TCM’s and, when possible, makes structural modifications to improve desirable drug properties and/or reduce undesirable drug properties.  An example developed by Syntex, is a drug prepared from a naturally-derived, already-known compound: mycophenolic acid.  Syntex derivatized it to a patentable compound, Mycophenolate Mofetil, which has now been approved by the FDA, as CellCept, for use in organ transplantation.

Another tactic is to isolate high molecular weight (HMW) compounds from TCM's.  This approach has been overlooked, but promises to provide new drug candidates, especially when tied to bioassay-guided isolation.

Our aggressive patent strategy has allowed Pharmagenesis, Inc. to develop an extensive patent estate.


[1]  Newman, D.J., Cragg, G.M., and Snader, K.M., [J. Nat. Prod., 66, 1022 (2003)]

[2] P. Unshuld, Medicine in China: A History of Ideas, University of California, Berkeley (1985).

[3] MDIS Publication Ltd., The Chinese Medical Market (December 1995).

 

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