Paclitaxel Story
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Discovery of Paclitaxel Anti-cancer activity:

Paclitaxel's anti-cancer activity was discovered in the 1960s during a large-scale plant-screening program sponsored by the National Cancer Institute (NCI).

35,000 plant species were screened for anticancer activity. The  U.S. Forest service collected Pacific yew tree (Taxus brevifolia) bark and shipped it to the NCI for study.

Drs. Monroe Wall and M.D. Wani of Research Triangle Institute, North Carolina subsequently find that an extract of the Yew Tree bark has antitumor activity.  That compound was named "Paclitaxel" or "Taxol".

Unique mechanism of action:

Interest in developing the drug increased in 1979 after Paclitaxel's unique mechanism of action-tubulin polymerization-is identified by Susan Horowitz, Ph.D., at Albert Einstein College of Medicine, New York.

Paclitaxel prevents cell division by promoting disassembly of microtubules - skeletal structures that assemble and divide throughout the life of a cell.
A large number of microtubules are formed at the start of cell division, and as cell division comes to an end, these microtubules are normally broken down. However, paclitaxel prevents microtubules from breaking down. In the presence of this drug, cancer cells, which attempt to divide frequently, become so clogged with microtubules that they cease to grow and divide.

Paclitaxel Clinical Trials:

In 1983, NCI began conducting clinical trials of paclitaxel's safety and its effectiveness against various types of cancer.

Demand for paclitaxel increased in 1989 after the investigators at The Johns Hopkins Oncology Center reported that the drug produced partial or complete responses (shrinking or disappearance of the tumor) in 30 percent of previously treated patients with advanced ovarian cancer.  it was clear that ovarian cancer patients with few other options benefited from the treatment.

In December 1992, FDA approved the use of paclitaxel for refractory (treatment-resistant) ovarian cancer.

Subsequently, clinical trials using paclitaxel for the treatment of advanced breast cancer demonstrated that the drug is effective against this disease.

In April 1994, FDA approved the use of paclitaxel for breast cancer that has recurred within 6 months after the completion of initial chemotherapy and for metastatic breast cancer that is not responding to combination chemotherapy.

March 1997, FDA designated Taxol as Orphan Drug for treatment of AIDS-related Kaposi's sarcoma. 

April 1998, FDA gave an additional approval for Paclitaxel injections, for first-line therapy for the treatment of advanced carcinoma of the ovary in combination with cisplatin.

June 1998, BMS received an NDA 20-262/S-024 for a Taxol indication: in combination with Cisplatin, for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or
radiation therapy

Researchers continue to look for new and better ways to use Paclitaxel in the treatment of cancer. They are studying Paclitaxel's effectiveness when used to treat breast and ovarian cancer earlier in the course of these diseases and when used in combination with other drugs.

Trials to test the effectiveness of Paclitaxel against many other types of cancer, including leukemia, lymphoma, and cancers of the lung, head and neck, and colon, also are in progress. In addition, researchers are investigating ways to overcome some patients' resistance to Paclitaxel and are trying to develop methods for using the drug in patients who have impaired organ function To date, more than 167 clinical trials  have been conducted by NIH (USA), researchers have found the drug to be active in lung, head and neck, bladder, esophageal, and germ cell cancers. 

Someone called it "Aspirin-like" - used for wide range of cancer disease.

Paclitaxel Supply Approaches:

Early research using Paclitaxel was limited by a restricted supply due to several difficulties in obtaining the drug. The concentration of the compound in yew bark is low (Taxol content of 0.002% in yew leaves), and Paclitaxel extraction is complex and expensive. The Pacific yew is a limited resource, it grows very slow and is located in old-growth forests that are the habitat of the endangered spotted owl.

As demand for paclitaxel increased,  researchers have been exploring  new ways to increase the availability of Paclitaxel.

Since January 1991, Bristol-Myers Squibb has been selected by NIH as the CRADA (Cooperative Research and Development Agreement) partner for Taxol. (This agreement was valid until Dec. 1997.)

Bristol-Myers Squibb produces Paxlitaxel Injection (Taxol, Registered Trademark) via a semi-synthesis process from Taxus baccata, the Europe Yew tree.

Many European and Indian companies are using semi-synthesis approach as well.

To use cell culture or fungi fermentation techniques to produce Taxol are also developed.

Yew tree species with high yield of 10DAB or Paclitaxel for cultivation are available. i.e. Taxus media Hicksii, its Taxol content reaches 0.026 % -  - 0,045%.

Total synthesis of Paclitaxel was achieved in 1994. However it is unlikely to be applied in the commercial production of Paclitaxol.

New Resource of NaturaL Paclitaxel 
  - Taxus yunnanensis or Taxus chinensis

There have been many research reports on the constitutions of othet yew tree species worldwide.

Scientists in US, China, Japan, Taiwan and other countries have done detailed research on Taxus yunnanensis or Taxus chinensisi (Chinese yew) as the new resource of Paclitaxel. There are four Chinese yew species growing on the territory of China. Scientists proved that all of them contain Paclitaxel at a similar level as the Taxus brevifolia.

Scientists have isolated and identified 110 taxanes from Chinese yews, and 36 of them were new taxanes. in vitro and in vivo studies proved that Paclitaxel is the most active anti-cancer compound among all these yew tree taxanes.

Clinical trials in China since 1995 have proved the effectiveness and safety of Natural Paclitaxel Injection (which contains Paclitaxel extracted from Taxus yunnanensis or Taxus chinensis) in cancer treatment.

In recent 8 years, very large planting fields of yew trees have been established in China to supply it.  Chinese manufacturers incorporates with Chinese academic institutions have developed the protocol to use HPLC technology to extract and purify Paclitaxel fro m yew tree materials without any semi-synthesis procedure. So we call it "Natural Paclitaxel".

Scientific evidences confirmed that 99.5% Natural Paclitaxel can reach the highest quality level of Paclitaxel product.

The Natural Paclitaxel from Taxus yunnanensis or Taxus chinensis is becoming an invaluable and important new resource of Paclitaxel. Due to its high quality and lower cost, many west pharmaceutical companies  and research laboratories have turned to this new resource of Paclitaxel. (including the giant drug companies. i.e. IVAX already claimed in its package-insert that both Taxus brevifolia and Taxus yunnanesis are the source of its Paclitaxel Injection. )

21CEC have been involved in helping developing the highest quality Paclitaxel  (99,5%, Injectable grade) as active substance used for EU generic Paclitaxel Injection. We keep inspecting  and  monitoring the details of DMF file, the GMP condition, the whole prcessing of its production, and its high quality was double checked in west laboratories.

That's why we can guarantee the high quality of Paclitaxel provided by us. Get a quote

 

 


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