Bauchspeicheldrüsen Krebs ....Hat Lorus Therapeutics die Lösung? - 500 Beiträge pro Seite

[morchel]

Bereits in Phase III der Erprobung!

Lorus receives fast track designation from FDA for Virulizin(R) for the treatment of pancreatic cancer
Jump to first matched term

- Designation represents another significant regulatory achievement

for Virulizin(R) -

TORONTO, June 4 /PRNewswire-FirstCall/ - Lorus Therapeutics Inc. ("Lorus") announced today that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation for Virulizin(R) in the treatment of pancreatic cancer. Virulizin(R) is the company`s most advanced drug in clinical development, currently being studied in a North American Phase III clinical trial.

The Fast Track designation means that the FDA will take actions to facilitate the development and expedite the review of Virulizin(R). Drugs designated for Fast Track are intended for the treatment of a life-threatening condition and have demonstrated the potential to address unmet medical needs. Fast Track products usually meet the FDA`s criteria for priority review.

"Clearly the FDA recognizes the devastating effects of pancreatic cancer and the urgent need for new therapies to treat patients with this disease," said Dr. Jim Wright, chief executive officer, Lorus. "This regulatory achievement is further confirmation of the potential of Virulizin(R) as an effective anticancer drug, and we are working hard to progress our Phase III clinical trial program to the New Drug Application stage."

Virulizin(R) is a potent and unique immunotherapy that directly stimulates macrophages and enhances their ability to kill tumor cells. Virulizin(R) is being studied as a first line therapy in combination with gemcitabine for the treatment of pancreatic cancer. The Phase III clinical trial of Virulizin(R) is a double-blind, randomized clinical trial being conducted at medical centers around North America enrolling 350 patients with advanced (unresectable, recurrent or metastatic) pancreatic cancer. Patients are randomized to receive either treatment with gemcitabine or treatment with gemcitabine in combination with Virulizin(R). Those patients who fail or become refractory to gemcitabine are treated with 5-Fluorouracil (5-FU) or with 5-FU in combination with Virulizin(R) in a second line therapy. All study subjects will be monitored throughout the remainder of their lifespan.

Virulizin(R) has already been awarded Orphan Drug Status from the FDA in 2001. It also is approved in Mexico for the treatment of malignant melanoma.

About Lorus

Lorus Therapeutics Inc. is a biopharmaceutical company specializing in the research, development and commercialization of pharmaceutical products and technologies for the management of cancer. With products in all stages of evaluation, from pre-clinical through Phase III trials, and a product approved in Mexico for malignant melanoma, Lorus is a leader in the development of therapeutics that seek to manage cancer with efficacious non-toxic compounds that improve patients` quality of life. Founded in 1986, Lorus Therapeutics Inc. is a public company listed on the Toronto Stock Exchange under the symbol LOR, and on the OTC BB exchange under the symbol LORFF. Lorus Therapeutics Inc.`s press releases are available through the Company`s Internet site: http://www.lorusthera.com.

Sollte auf keiner Watchlist fehlen....

morchel
.....der bald auch eine eigene Biotechseite aufmachen wird...

[morchel]

Der Chart:



Bid übrigends weit höher als der Schlußkurs gestern!

morchel

[koalabaer25]

Die Biotechs haben einen wirklich dramatischen Selloff hinter sich, der vielleicht noch weiter geht. Bevor ich diesen Pennystock kaufe, lege ich mir lieber einen Nasdaq-Wert ins Depot, z.B. Cytogen (CYTO) der um 1 $ notiert. Bei diesem Wert weiß ich, daß ich mich in bester institutioneller Gesellschaft befinde. Und es gibt noch weitere Nasdaq-Werte die nahe ihrem ATL notieren.

Koalabaer

[morchel]

du hast vollkommen recht Koalabär. Dennoch haben die NASDAQ Werte einen guten Grund das sie meist so tief notieren! Riesige Cashburner ohne ergebnisse!

Bei einem OTCBB wert weiß ich zumindest das ich mich auf sehr glatten eis bewege!

morchel

[koalabaer25]

Hi Morchel,

bei Lorus ist mir das Handelsvolumen zu niedrig. Deine Argumentation ist natürlich auch richtig, gilt aber nicht für Cytogen (sonst hätt ich die nämlich nicht erwähnt). Haben schon zugelassene Produkte am Markt!

Koalabaer

[morchel]

Neuerliche News von Lorus! und keine Schlechten....

TORONTO, June 7 /PRNewswire-FirstCall/ - Lorus Therapeutics Inc. ("Lorus") today announced data demonstrating the potential of its R1 tumor suppressor for the treatment of cancer. The results support the company`s emerging gene therapy platform and will be presented today at the Fifth Annual Meeting of the American Society of Gene Therapy (ASGT) in Boston, Massachusetts.
Recently, Lorus announced the allowance of a patent to protect the company`s innovative approach to inhibiting tumor growth utilizing the R1 gene of ribonucleotide reductase. The gene is delivered to cancer cells by a vector that transports the gene to the target cancer cells. In the study to be presented today, the gene is delivered with a modified adenovirus vector called rAd5-R1. Adenoviruses are widely used vectors in the study of gene therapy.

Several models were constructed to study rAd5-R1 for its potential to inhibit human colon cancer growth. In vitro studies of rAd5-R1 resulted in a significant inhibition of cell proliferation in a dose- and time-dependent manner.

In ex vivo studies, human colon cancer cells were treated with either a saline control or infected overnight with Lorus` rAd5-R1 or with rAd5-LacZ, a recombinant adenovirus encoding B(beta)-Galactosidase to be used as a vector control. The cells were then subcutaneously injected into mice. The difference in resulting tumor size was very significant between the rAd5-R1-treated group and the rAd5-LacZ-treated group (p(equal sign)0.0003). There was no significant difference between the saline control group and the rAd5-LacZ- treated group (p(equal sign)0.6188).

In vivo studies with rAd5-R1 also demonstrated significant inhibition of tumor growth in xenograft models of mice bearing human colon cancer cells, a very aggressive and fast growing tumor type. When the tumors reached a volume of approximately 50-100 mm3, the mice were injected with either rAd5-R1 or rAd5-LacA intratumorally. The drug was administered only five times during the 28-day treatment period. rAd5-R1 significantly inhibited tumor growth (p(equal sign)0.013) compared with the tumor growth after treatment with rAd5-LacZ.

"The significant pre-clinical findings suggest that R1 gene therapy to treat human cancers could be an attractive approach, and supports further investigation of the potential clinical application of R1 gene therapy," said Dr. Jim Wright, chief executive officer, Lorus Therapeutics Inc. "Our multi- platform approach to developing anticancer drugs has been enhanced by these recent findings and we continue to add value to our pipeline through our research activities and ongoing clinical development programs."

Lorus` strategy is to develop cancer therapeutics with different mechanisms of action that may be efficacious against a wide variety of cancers. This approach means increased opportunities to help people afflicted with cancer, and also helps mitigate the risk to shareholders. The company`s gene therapy platform is one of a number of preclinical programs being studied for their clinical potential. Lorus drugs already in the clinic include the late stage immunotherapeutic drug Virulizin(R), in a Phase III clinical trial for the treatment of pancreatic cancer. GTI-2040, the company`s lead antisense drug, is in a Phase II clinical trial for the treatment of renal cell carcinoma, and another antisense drug, GTI-2501, is in a Phase I clinical trial.

About ASGT

The ASGT is the largest medical professional organization representing researchers and scientists discovering new gene therapies. ASGT is committed to promoting and fostering the exchange and dissemination of information and ideas related to gene therapy as well as encouraging the general field of research involving gene therapy. ASGT was established in 1996, and has approximately 3,000 members from around the world.


morchel