Anti-Cancer Mushroom Toxin Gets FDA Fast-Track Status

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Anti-Cancer Mushroom Toxin Gets FDA Fast-Track Status

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Anti-Cancer Mushroom Toxin Gets FDA Fast-Track

Status

A novel anti-cancer compound was synthesized by

scientists at the University of California, San Diego, more than a decade ago

from toxins of the poisonous jack-o-lantern mushroom.

Now that compound has been granted " fast track "

status by the U.S. Food and Drug Administration (FDA) after demonstrating

promise against one of the deadliest of cancers.

" Fast track " designation, an important accelerated

phase in the nation's drug review and approval process, signifies that the FDA

can expedite the review and development of the drug candidate irofulven, which

in clinical studies has demonstrated shrinkage of solid tumors of the pancreas

and other cancers.

Pancreatic cancer claims an estimated 29,000 lives

each year in the United States and about 170,000 lives worldwide. It is one of

the most deadly malignancies and has few effective treatment options.

Irofulven is currently being developed by MGI

PHARMA, Inc., an emerging pharmaceutical company based in Minneapolis. Phase III

clinical trials involving the drug have been underway since early this year at

sites in the U.S. and Europe.

" It's very exciting and rewarding to see the drug

reach another important milestone as it moves toward possible approval by the

FDA, " says Trevor Mc, UCSD professor of chemistry, who, with

Kelner, professor of pathology in the UCSD School of Medicine, led the original

biochemical and biomedical research studies involving the drug.

In 1989, Mc and Kelner first demonstrated

the anti-tumor activity of acyl fulvenes, the chemical compound family from

which irofulven is derived.

(Acyl fulvenes, in turn, originate from illudin-S,

a toxic constituent of the jack-o-lantern mushroom.)

Mc and Kelner later began testing and

comparing the metabolism of acyl fulvenes with that of illudin-S in animal

studies, gaining further insight into the compounds' anti-tumor activity.

The two scientists, both members of the UCSD

Cancer Center, are continuing to explore and test other acyl fulvene-based

cancer drug analogs.

" We've followed the progress of this drug with

great interest, " says Kelner, " especially as it advanced from Phase I and II of

clinical trials conducted by MGI PHARMA and the National Cancer Institute. Now

that irofulven is in a Phase III clinical trial and has received a 'fast track'

designation, it's rewarding to realize this drug could be in its final stage

towards receiving FDA approval and may become available to help thousands of

cancer patients. "

Irovulven appears promising in pancreatic cancer

patients who are no longer responding to gemcitabine, the conventional drug

treatment for this disease.

In addition, the compound has also demonstrated

activity against ovarian cancer and prostate cancer, particularly with patients

who have had limited or no success with such standard cancer drugs as

cisplatinum and paclitaxel.

In 1993, MGI PHARMA acquired the rights from the

University of California to all illudin-S analogs devised by Mc and

Kelner, including irofulven, which was first synthesized by Mc.

Irofulven's unique mechanism of action as an

anti-tumor agent is due to its ability to be rapidly absorbed by tumor cells.

Once inside the cells, the compound binds to DNA and protein targets. This

binding interferes with DNA replication and cell division of tumor cells,

leading to tumor-specific apoptosic cell death, or " cell suicide. "

During this process, tumor cells tend to

automatically shut themselves down when they sense their function is

compromised.

Patients and health care providers seeking

information on the various irofulven clinical trials may call MGI PHARMA's

Medical Communications Help Line at 1-800-562-5580 or the National Cancer

Institute's Cancer Information Service at 1-800-4-CANCER (TTY 1-800-332-8615).

15-Aug-2001

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Anti-Cancer Mushroom Toxin Gets FDA Fast-Track Status

Home Search

Anti-Cancer Mushroom Toxin Gets FDA Fast-Track

Status

A novel anti-cancer compound was synthesized by

scientists at the University of California, San Diego, more than a decade ago

from toxins of the poisonous jack-o-lantern mushroom.

Now that compound has been granted " fast track "

status by the U.S. Food and Drug Administration (FDA) after demonstrating

promise against one of the deadliest of cancers.

" Fast track " designation, an important accelerated

phase in the nation's drug review and approval process, signifies that the FDA

can expedite the review and development of the drug candidate irofulven, which

in clinical studies has demonstrated shrinkage of solid tumors of the pancreas

and other cancers.

Pancreatic cancer claims an estimated 29,000 lives

each year in the United States and about 170,000 lives worldwide. It is one of

the most deadly malignancies and has few effective treatment options.

Irofulven is currently being developed by MGI

PHARMA, Inc., an emerging pharmaceutical company based in Minneapolis. Phase III

clinical trials involving the drug have been underway since early this year at

sites in the U.S. and Europe.

" It's very exciting and rewarding to see the drug

reach another important milestone as it moves toward possible approval by the

FDA, " says Trevor Mc, UCSD professor of chemistry, who, with

Kelner, professor of pathology in the UCSD School of Medicine, led the original

biochemical and biomedical research studies involving the drug.

In 1989, Mc and Kelner first demonstrated

the anti-tumor activity of acyl fulvenes, the chemical compound family from

which irofulven is derived.

(Acyl fulvenes, in turn, originate from illudin-S,

a toxic constituent of the jack-o-lantern mushroom.)

Mc and Kelner later began testing and

comparing the metabolism of acyl fulvenes with that of illudin-S in animal

studies, gaining further insight into the compounds' anti-tumor activity.

The two scientists, both members of the UCSD

Cancer Center, are continuing to explore and test other acyl fulvene-based

cancer drug analogs.

" We've followed the progress of this drug with

great interest, " says Kelner, " especially as it advanced from Phase I and II of

clinical trials conducted by MGI PHARMA and the National Cancer Institute. Now

that irofulven is in a Phase III clinical trial and has received a 'fast track'

designation, it's rewarding to realize this drug could be in its final stage

towards receiving FDA approval and may become available to help thousands of

cancer patients. "

Irovulven appears promising in pancreatic cancer

patients who are no longer responding to gemcitabine, the conventional drug

treatment for this disease.

In addition, the compound has also demonstrated

activity against ovarian cancer and prostate cancer, particularly with patients

who have had limited or no success with such standard cancer drugs as

cisplatinum and paclitaxel.

In 1993, MGI PHARMA acquired the rights from the

University of California to all illudin-S analogs devised by Mc and

Kelner, including irofulven, which was first synthesized by Mc.

Irofulven's unique mechanism of action as an

anti-tumor agent is due to its ability to be rapidly absorbed by tumor cells.

Once inside the cells, the compound binds to DNA and protein targets. This

binding interferes with DNA replication and cell division of tumor cells,

leading to tumor-specific apoptosic cell death, or " cell suicide. "

During this process, tumor cells tend to

automatically shut themselves down when they sense their function is

compromised.

Patients and health care providers seeking

information on the various irofulven clinical trials may call MGI PHARMA's

Medical Communications Help Line at 1-800-562-5580 or the National Cancer

Institute's Cancer Information Service at 1-800-4-CANCER (TTY 1-800-332-8615).

15-Aug-2001

Add the UniSci Daily Java News Ticker to Your Site or Desktop.

Click for a demo and more information.

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| PROSTATE | POLIO

Please direct website technical problems or questions to

webmaster@....

Copyright © 1995-2001 UniSci. All rights reserved.