Cell Therapeutics to Submit New XYOTAX Drug Trial to FDA

Cell Therapeutics announced on Friday that it will close a XYOTAX drug trial, known as PIONEER, to submit a new trial protocol to the Food and Drug Administration (FDA). The new protocol will be known as PGT306 and will be submitted to the FDA by year's end.

Because of the particularly low death rate among women patients during the trial, CTIC wants to focus its research on women with normal estogen levels. CEO Dr. James Bianco hopes that this group will be able to increase its uptake and metabolism of the chemotherapeutic drug because of estrogen.

Shares of CTIC dipped 2.2% to $1.86 on 8 December 2006.



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Cell Therapeutics To Suspend Enrollment for PIONEER Drug Trial
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Cell Therapeutics Signs Deal With Norvatis
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Technorati Tags: cell therapeutics, ctic, cancer drug, drug trial, xyotax, pioneer, pgt306, james bianco

Cell Therapeutics To Suspend Enrollment for PIONEER Drug Trial

Cancer drug developer, Cell Therapeutics (CTIC, financial info), has announced on November 3 2006 that it has suspended further enrollment of test patients for its lung cancer trial, called PIONEER, to analyze the differences in early cycle deaths. The company will need to study the differences of deaths between patients who were administered the trial drug, XYOTAX, and those who were given standard paclitaxel. In addition, as recommended by the Data Safety Monitoring Board, CTIC will continue its treatment for existing patients as per protocol.

CTIC has decided to amend the primary efficacy endpoint of the study according to the recommendations from the Food and Drug Administration (FDA). The survival results of women with normal estrogen levels will be the target and this protocol change will be submitted to the FDA for approval. This will likely delay the interim analysis results of PIONEER by at least six months.

CTIC traded down 1 cent (0.6 percent) on moderate volume on Friday November 3 2006.

Update November 7 2006 1006hrs:

The stock plunged 13 cents or 7.93% at the end of Monday November 6 2006.

Related posts:

Cell Therapeutics Signs Deal With Norvatis
<URL:http://glob.lokety.com/2006/09/cell-therapeutics-signs-deal-with.html>

Cell Therapeutics Up After Positive Xyotax Phase 1 Results
<URL:http://glob.lokety.com/2006/08/cell-therapeutics-up-after-positive.html>

Cell Therapeutics Signs Financing Agreement
<URL:http://glob.lokety.com/2006/06/cell-therapeutics-signs-financing.html>

Technorati Tags: cell therapeutics, ctic, xyotax, pioneer, drug trial, dsmb, fda, data safety monitoring board, food and drug administration

Cell Therapeutics Signs Deal With Norvatis

Cell Therapeutics (CTIC) has signed a worldwide licensing deal with Norvartis worth US$285M. This agreement will see Norvatis assisting in the development and commercialisation of Cell Therapeutics' flagship drug, XYOTAX. The amount includes US$15M equity investment in the drug development company as well.

Cell Therapeutics traded up 13 cents or 6.67% on Monday to $2.08.



Technorati Tags: cell therapeutics, ctic, xyotax, licensing deal, agreement, novartis, drug, cancer, investment

Cell Therapeutics Up After Positive Xyotax Phase 1 Results

Cell Therapeutics stock was up after positive results from 91 percent target achievement rate was reported in the August issue of the American Journal of Clinical Oncology. Twelve patients with esophageal or gastric cancer has been tested with the cancer drug Xyotax.

Dr. Howard Safran of Brown University says that Xyotax may "replace paclitaxel as the most important radiation sensitizer in solid tumors". If this is true, we may see a future without the need for or less side effects from chemotherapy drugs.

CTIC closed $1.61 on Thursday 24 August 2006.


Technorati Tags: cell therapeutics, ctic, xyotax, results, cancer, tumor, chemotherapy, drug

Cell Therapeutics Signs Financing Agreement

Cell Therapeutics (CTIC) has entered a financing agreement with Societe Generale Group for the French bank to buy $55M new shares to trade on the Italian stock exchange.

Societe Generale Group will have the option to purchase an additional $17M over the next 24 months.

CTIC is a biotechnology company that develops drugs to combat cancer and related conditions. It's flagship product, XYOTAX, is undergoing trails for approval and sale.

Source: The Associated Press

<URL:http://news.moneycentral.msn.com/provider/providerarticle.asp?feed=AP&Date=20060621&ID=5812747>

Technorati Tags: cell therapeutics, societe generale group, shares, biotechnology, xyotax, market, financing agreement