Paclitaxel: profile and news

Herceptin® Plus Doxil® Safe and Effective in Metastatic Breast ...  16 May 2006
...postivive, metastatic breast cancer (cancer that has spread to distant sites in the body) in combination with the chemotherapy agent Taxol® (paclitaxel) or as ... - Cancer Consultants (press release),

ATLAS trial results show second-generation Taxus stent to match ...  16 May 2006
Paris, France - Revascularization rates for the paclitaxel-eluting Taxus Liberté stent mirror those of its predecessor, the Taxus Express 2, making it the ... - TheHeart.Org,

TAXUS ATLAS trial supports superior deliverability and proven ...  16 May 2006
...the TAXUS Express(2) paclitaxel-eluting stent system. The trial met its. repeat procedure. The nine-month TVR rate for the TAXUS Liberté stent was. 8.0 percent. ... - Les Affaires (Communiqués de presse),

The three-year results for TAXUS VI support long-term safety with ...  16 May 2006
The TAXUS. commercial distribution. BSC acquired worldwide exclusive rights from Angiotech to use paclitaxel. vascular and non-vascular products. ... - Les Affaires (Communiqués de presse),

Paclitaxel-Eluting Stent Effective for High-Risk Patients ...  May 15, 2006
CHICAGO, IL -- May 15, 2006 -- Paclitaxel-eluting stents (Taxus) appear to have a good safety profile and satisfactory clinical outcomes in high-risk patients ... - DG News

US FDA Grants Orphan Drug Designation to OXiGENE's Lead Clinical ...  May 15, 2006
CA4P is being evaluated in a Phase II clinical trial in combination with the widely used chemotherapy regimen, carboplatin and paclitaxel, for the treatment of ... - Genetic Engineering News,

Paclitaxel efficacy enhanced by novel compound 73R  Apr 20, 2006
A novel agent dubbed 73R enhances the efficacy of paclitaxel in a murine cancer model. In a paper published in the Journal of Medicinal ... - Therapeutics Daily (subscription) (press release),

Sonus Pharmaceuticals Reports First Quarter Progress and Financial ...  May 10, 2006
Completing enrollment in the Phase 3 pivotal trial of the Company's lead product candidate, TOCOSOL(R) Paclitaxel, in patients with metastatic breast cancer. ... - Business Wire (press release),

Angiotech Pharmaceuticals, Inc. announces results for the first ...  May 9, 2006
...of $41.9 million, with $39.4 million of total revenues representing royalties derived from sales by Boston Scientific (BSC) of paclitaxel-eluting coronary ... - Canada NewsWire (press release),

Sonus Pharmaceuticals to Release First Quarter 2006 Financial ...  May 4, 2006
4:30 PM EDT, management will host a conference call to provide a company update, including a review of the progress with TOCOSOL(R) Paclitaxel, the Company's ... - Genetic Engineering News,

Sonus Pharmaceuticals Q1 Net Loss Widens On Higher Research And ...  May 10, 2006
...results, reporting a net loss that widened on continued investment by the company in the clinical and regulatory development of cancer drug Tocosol Paclitaxel. ... - Trading Markets,

COMUNICADO: Boston Scientific to Release Latest Clinical Trial ...  May 9, 2006
...current drug-eluting stent platform, as well as the deliverability and efficacy of our second generation product, the TAXUS Liberte paclitaxel-eluting coronary ... - Europa Press,

Angiotech Pharmaceuticals, Inc. Announces Results for the First ...  May 9, 2006
...compared to the same quarter in the prior year was primarily a result of a decrease in royalty revenue derived from the sale of paclitaxel-eluting coronary ... - PharmaLive.com (press release),

Cytochroma announces significant results with CTA002, a vitamin D ...  May 10, 2006
Using the LNCaP prostate model, Cytochroma was able to demonstrate a significant effect on tumor suppression with CTA002 in combination with paclitaxel. ... - Yahoo! News (press release)

ACC/AHA update secondary-prevention guidelines  May 15, 2006
...mg/day should be given for a month; for those receiving a sirolimus-eluting (Cypher) stent, this should be three months; and for the paclitaxel-eluting (Taxus ... - TheHeart.Org,

Sonus Pharmaceuticals loses $5.3M in Q1  May 10, 2006
NASDAQ: SNUS) officials said the recent loss was attributable to an "increased level of spending" as the biotech invests in its Tocosol Paclitaxel cancer drug. ... - Bizjournals.com,

Highlights of rising and falling US stocks  May 15, 2006
...vascular-disrupting agent is currently being evaluated in a Phase II trial in combination with the chemotherapy regimen of carboplatin and paclitaxel for the ... - Investor's Business Daily (subscription)

Two methods, after surgery, for women with advanced ovarian cancer  May 5, 2006
It compared two treatment regimens: 1) IV Paclitaxel followed by IV Cisplatin, to 2) IV Paclitaxel followed by IP Cisplatin and the subsequent administration ... - Xagena.it,

Sonus Pharmaceuticals Closes $30.6 Million Registered Direct ...  May 4, 2006
The Company's lead product candidate is TOCOSOL(R) Paclitaxel, a ready-to-use, injectable formulation of the anti-cancer drug, paclitaxel. ... - Genetic Engineering News,

Advancing Nanoparticle-Based Imaging and Therapy of Brain Cancer  May 13, 2006
Albumin nanoparticles have already been used successfully to deliver the anticancer drug paclitaxel to breast tumors as part of the recently approved drug ... - Nanotechwire.com,

Conor Medsystems Initiates RAPID Clinical Study For First ...  May 13, 2006
...be compared with historical controls from Arm 1 of Conor's EuroSTAR study which evaluated the company's CoStar(TM) cobalt chromium paclitaxel-eluting coronary ... - Medical News Today (press release),

Boston Scientific Files Patent Infringment Suit Against Conor ...  May 4, 2006
...(CONR | charts | news | PowerRating), alleging that the Conor CoStar Paclitaxel-Eluting Coronary Stent System infringes a balloon catheter patent owned by ... - Trading Markets,

Boston Scientific Sues Conor Medsystems  May 6, 2006
Saturday press release that it has filed a lawsuit in Ireland against Conor Medsystems Ireland Ltd., alleging that the Conor CoStar Paclitaxel-Eluting Coronary ... - ag-IP-news Agency,

Einstein's Susan Band Horwitz, PhD Wins Bristol-Myers Squibb ...  Apr 29, 2006
Her pivotal research in the 1980's eventually led to the development of paclitaxel (Taxol®), one of the most important anti-cancer agents ever developed. ... - Medical News Today (press release),

Drug firm shut out  Apr 16, 2006
Pharma in St. Catharines. Biolyse produces Paclitaxel, one of the most powerful, but gentle treatments for cancer. It is administered ... - Hamilton Spectator,

NICE Issues First Rapid Appraisal Draft Guidance On Docetaxel And ...  Apr 28, 2006
Draft guidance on the clinical and cost-effectiveness of docetaxel and paclitaxel for the treatment of early breast cancer following surgery is now available ... - Medical News Today (press release),

Boston Scientific Sues Conor Medsystems Ireland Ltd.  May 4, 2006
..., alleging that the Conor CoStar(TM) Paclitaxel-Eluting Coronary Stent System infringes a balloon catheter patent owned by Boston Scientific. ... - PharmaLive.com (press release),

ADVENTRX ANNOUNCES CLOSING OF MERGER WITH SD PHARMACEUTICALS  May 1, 2006
For example, the novel formulations of paclitaxel and docetaxel were developed without formulation vehicles Cremophor(R) or polysorbate 80 which can cause ... - Small Times

Boston Scientific and Angiotech Win Patent Infringement Case ...  May 3, 2006
Boston Scientific and Angiotech alleged that Sahajanand's Infinnium paclitaxel-eluting stent infringed two claims of an Angiotech patent directed to paclitaxel ... - Yahoo! News (press release)

New Patent Granted for OXiGENE's Lead Therapeutic Candidate for ...  May 5, 2006
7037906), provides broad coverage through 2021 for the use and administration of CA4P in combination with paclitaxel, one of the most widely used ... - PharmaLive.com (press release),

Sonus Pharmaceuticals to Raise $30.6 Million in Registered Direct ...  Apr 28, 2006
...our balance sheet and provides greater flexibility to simultaneously fund our share of the remaining clinical development of TOCOSOL(R) Paclitaxel and to ... - Business Wire (press release),

Intraperitoneal chemotherapy administration prolongs survival for ...  Apr 25, 2006
The New England Journal of Medicine study, " Intravenous Cisplatin and Paclitaxel versus an intensive regimen of intravenous Paclitaxel, intraperitoneal ... - Xagena.it,

Sonus Pharmaceuticals raises $30 million  Apr 28, 2006
The company said the financing, slated to close May 2, will enable it to continue clinical trials of its Tocosol Paclitaxel treatment for metastatic breast ... - Seattle Times,

Microsoft Windows to have lower price in Africa  Apr 29, 2006
The company said the financing, scheduled to close Tuesday, will enable it to continue clinical trials of its Tocosol Paclitaxel treatment for metastatic ... - Seattle Times,

Angiotech Pharma 1Q profit drops  May 9, 2006
The figure included $39.4 million in royalty payments from Boston Scientific for sales of paclitaxel-eluting coronary stent systems, which are drug-coated mesh ... - BusinessWeek

Angiotech Overcomes Royalty Pain  May 9, 2006
Boston has a licensing agreement with Angiotech to use the drug paclitaxel to coat its stents, which are heart devices used to prop open vessels cleared of ... - TheStreet.com

Heart stent revenues reduce Angiotech earnings  May 9, 2006
Revenues for the quarter were $41.9 million, $39.4 million of that from royalties derived from sales by partner Boston Scientific's paclitaxel-eluting coronary ... - Toronto Star,

Business briefs  May 11, 2006
The Bothell company said the higher loss was the result of increased spending on clinical trials for Tocosol paclitaxel, its leading anti-cancer drug. ... - The Herald,

Harvard Vanguard names Geihsler chief executive  May 4, 2006
The court blocked the sale of Sahajanand's Infinnium paclitaxel stent in the Netherlands and ordered the company to pay Angiotech undisclosed damages, Boston ... - Boston Globe,

Earnings: Loss by Longview Fibre spurs call by suitors  May 10, 2006
...develops cancer drugs, said its higher net loss mainly reflected increased spending on the clinical and regulatory development of tocosol paclitaxel for breast ... - Seattle Post Intelligencer

Pro-Pharmaceuticals to Present Corporate Update at Rodman & ...  May 9, 2006
...studies with its lead product candidate, DAVANAT(R), in combination with 5-FU, leucovorin, irinotecan, doxorubicin, oxaliplatin, paclitaxel, cisplatin, and ... - Genetic Engineering News,

Boston Scientific, Angiotech Pharma Receive Favorable Judgement In ...  May 3, 2006
The companies alleged that Sahajanand's Infinnium paclitaxel-eluting stent infringed two claims of an Angiotech patent directed to paclitaxel stents. - Trading Markets,

Artist turns his wife's battle with cancer into a series of ...  May 9, 2006
...see. The title comes from the fact that hair loss normally occurs about 17 days after the start of treatment paclitaxel. Mary's ... - Spartanburg Herald Journal (subscription),

Drug-eluting and Bare-metal Stents Have Similar Long-Term Safety ...  May 12, 2006
Drug eluting stents were most commonly sirolimus-eluting stents (65%) while 35% were paclitaxel-eluting stents, Dr. Shapiro said during his presentation on May ... - DG News

New research from Italy, the United States and the United Kingdom ...  May 11, 2006
...with various chemotherapeutic drugs acting via different mechanisms, including, besides doxorubicin and melphalan, cisplatin, paclitaxel, and gemcitabine.". - Therapeutics Daily (subscription) (press release),

Natural Products Reemerge  May 10, 2006
Perhaps one of the most well-known natural products on the market is Taxol (paclitaxel), which became a blockbuster drug when it came on the market in 1993 for ... - Drug Discovery & Development (subscription),

EntreMed commences drug study in breast cancer  Apr 26, 2006
...a phase Ib study to test its lead clinical-stage drug candidate, Panzem NCD, in combination with the standard chemotherapeutic agent paclitaxel, in patients ... - Pharmaceutical Business Review

In a Phase I trial using escalating doses of TAXOL (110-200 mg/m²) and cisplatin (50 or 75 mg/m²) given as sequential infusions, myelosuppression was more profound when TAXOL was given after cisplatin than with the alternate sequence (ie, TAXOL before cisplatin). Pharmacokinetic data from these patients demonstrated a decrease in paclitaxel clearance of approximately 33% when TAXOL was administered following cisplatin.

The metabolism of TAXOL is catalyzed by cytochrome P450 isoen-zymes CYP2C8 and CYP3A4. In the absence of formal clinical drug interaction studies, caution should be exercised when administering TAXOL concomitantly with known substrates or inhibitors of the cytochrome P450 isoenzymes CYP2C8 and CYP3A4.

Potential interactions between TAXOL, a substrate of CYP3A4, and protease inhibitors (ritonavir, saquinavir, indinavir, and nelfinavir), which are substrates and/or inhibitors of CYP3A4, have not been evaluated in clinical trials.

Reports in the literature suggest that plasma levels of doxorubicin (and its active metabolite doxorubicinol) may be increased when paclitaxel and doxorubicin are used in combination.

Hematology: TAXOL therapy should not be administered to patients with baseline neutrophil counts of less than 1,500 cells/mm³. In order to monitor the occurrence of myelotoxicity, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving TAXOL. Patients should not be re-treated with subsequent cycles of TAXOL until neutrophils recover to a level >1500 cells/mm³ and platelets recover to a level >100,000 cells/mm³. In the case of severe neutropenia (<500 cells/mm³ for seven days or more) during a course of TAXOL therapy, a 20% reduction in dose for subsequent courses of therapy is recommended.

For patients with advanced HIV disease and poor-risk AIDS-related Kaposi’s sarcoma, TAXOL, at the recommended dose for this disease, can be initiated and repeated if the neutrophil count is at least 1000 cells/mm³.

Hypersensitivity Reactions: Patients with a history of severe hypersensitivity reactions to products containing Cremophor^® EL (eg, cyclosporin for injection concentrate and teniposide for injection concentrate) should not be treated with TAXOL. In order to avoid the occurrence of severe hypersensitivity reactions, all patients treated with TAXOL should be premedicated with corticosteroids (such as dexamethasone), diphen-hydramine and H2 antagonists (such as cimetidine or ranitidine). Minor symptoms such as flushing, skin reactions, dyspnea, hypotension, or tachycardia do not require interruption of therapy. However, severe reactions, such as hypotension requiring treatment, dyspnea requiring bronchodilators, angioedema, or generalized urticaria require immediate discontinuation of TAXOL and aggressive symptomatic therapy. Patients who have developed severe hypersensitivity reactions should not be rechallenged with TAXOL.

Cardiovascular: Hypotension, bradycardia, and hypertension have been observed during administration of TAXOL, but generally do not require treatment. Occasionally TAXOL infusions must be interrupted or discontinued because of initial or recurrent hypertension. Frequent vital sign monitoring, particularly during the first hour of TAXOL infusion, is recommended. Continuous cardiac monitoring is not required except for patients with serious conduction abnormalities.

Nervous System: Although the occurrence of peripheral neuropathy is frequent, the development of severe symptomatology is unusual and requires a dose reduction of 20% for all subsequentcourses of TAXOL.

TAXOL contains dehydrated alcohol USP, 396 mg/mL; consideration should be given to possible CNS and other effects of alcohol.

Hepatic: There is limited evidence that the myelotoxicity of TAXOL may be exacerbated in patients with serum total bilirubin >2 times ULN. Extreme caution should be exercised when administering TAXOL to such patients, with dose reduction as recommended in DOSAGE AND ADMINISTRATION, Table 17.

InjectionSite Reaction: Injection site reactions, including reactions secondary to extravasation, were usually mild and consisted of erythema, tenderness, skin discoloration, or swelling at the injection site. These reactions have been observed more frequently with the 24-hour infusion than with the 3-hour infusion. Recurrence of skin reactions at a site of previous extravasation following administration of TAXOL at a different site, ie, "recall", has been reported rarely.

Rare reports of more severe events such as phlebitis, cellulitis, induration, skin exfoliation, necrosis, and fibrosis have been received as part of the continuing surveillance of TAXOL safety. In some cases the onset of the injection site reaction either occurred during a prolonged infusion or was delayed by a week to ten days.

A specific treatment for extravasation reactions is unknown at this time. Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration.