Re: Pirfenidone Study......Good News!

[Guest guest]

For those that are interested, Stanford medical Center is doing a double blind study regarding this drug, I have applied to be included, now awaiting to see if I meet the criteria to be included? The side effects appear to tbe minimal compared to some of the chemo drugs? Sure hope it works. Louise/ipf/96/Calif.Joyce wrote: http://www.medadnews.com/News/index.cfm?articleid=402015 Shionogi: Results of Phase III Clinical Trials of the Idiopathic Pulmonary Fibrosis Treatment S-7701 OSAKA, December 22, 2006 — Shionogi & Co., Ltd. (Head Office: Osaka; President: Motozo Shiono) today announced that it has achieved the primary objectives of Phase III clinical trials for the idiopathic pulmonary fibrosis treatment S-7701 (generic name: pirfenidone), which the Company is developing in Japan under a license from U.S.-based Marnac, Inc. and KDL, Inc., Tokyo. Idiopathic pulmonary fibrosis (IPF) is a medical condition of unknown etiology with poor prognosis in which progressive fibrosis of the alveolar walls produces irreversible "honeycomb lung"*. In general, restrictive impairment (reduction of vital capacity (VC) and total lung capacity (TLC)) is

evident. As the symptom (fibrosis of the alveolar walls) progresses, gas exchange in the lungs (exchange of oxygen and carbon dioxide) becomes difficult. In some cases, oxygen therapy becomes necessary. Because of its severity, IPF is designated as a "specified disease" (in other words, an intractable disorder). Under development as a treatment for IPF, S-7701 has been designated as an orphan drug (a drug used to treat a rare disease) by the Pharmaceuticals and Medical Devices Agency. *Honeycomb lung: A high-resolution CT scan of the lung yields a honeycomb pattern. In the Phase III clinical trials for this drug with VC change (from before commencement of treatment to 52 weeks after commencing treatment) as the primary endpoint, both high and low doses of the drug (600mgl per day, three times a day and 400mgl per day, three times a day, respectively), significantly inhibited worsening of the condition

compared with a placebo. While continuing to conduct further analysis and study, Shionogi plans to expedite the application process based on these clinical results, with the intention of submitting a new drug application (NDA) within the current fiscal year. In the process of developing this drug, Shionogi has received many earnest inquiries from patients with IPF and their families regarding the extent of progress of development, and urgent requests for the medication. With this situation in mind, Shionogi intends to do its best to expedite submission and approval for S-7701 in order to offer the quickest possible relief to patients suffering from this disease. For further information, contact: Public Relations Unit Shionogi & Co., Ltd. (Osaka) Tel: +81-6-6209-7885 Fax: +81-6-6229-9596 (Tokyo) Tel: +81-3-3406-8164 Fax:

+81-3-3406-8099 __________________________________________________

[Guest guest]

Louise,

It reads as though they are going to push hard to get it approved and out to patients. Wonder what the cost will be for this????? It would be such a blessing if it worked....even to buy some time.

Hugs, Joyce> http://www.medadnews.com/News/index.cfm?articleid=402015 > Shionogi: Results of Phase III Clinical Trials of the Idiopathic > Pulmonary Fibrosis Treatment S-7701 > > OSAKA, December 22, 2006 — Shionogi & Co., Ltd. (Head Office: Osaka; > President: Motozo Shiono) today announced that it has achieved the > primary objectives of Phase III clinical trials for the idiopathic > pulmonary fibrosis treatment S-7701 (generic name: pirfenidone), > which the Company is developing in Japan under a license from U.S.-> based Marnac, Inc. and KDL, Inc., Tokyo. > > Idiopathic pulmonary fibrosis (IPF) is a medical condition of unknown > etiology with poor prognosis in which progressive fibrosis of the > alveolar walls produces irreversible "honeycomb lung"*. In general, > restrictive impairment (reduction of vital capacity (VC) and total > lung capacity (TLC)) is evident. As the symptom (fibrosis of the > alveolar walls) progresses, gas exchange in the lungs (exchange of > oxygen and carbon dioxide) becomes difficult. In some cases, oxygen > therapy becomes necessary. Because of its severity, IPF is designated > as a "specified disease" (in other words, an intractable disorder). > > Under development as a treatment for IPF, S-7701 has been designated > as an orphan drug (a drug used to treat a rare disease) by the > Pharmaceuticals and Medical Devices Agency. > > *Honeycomb lung: A high-resolution CT scan of the lung yields a > honeycomb pattern. In the Phase III clinical trials for this drug > with VC change (from before commencement of treatment to 52 weeks > after commencing treatment) as the primary endpoint, both high and > low doses of the drug (600mgl per day, three times a day and 400mgl > per day, three times a day, respectively), significantly inhibited > worsening of the condition compared with a placebo. > > While continuing to conduct further analysis and study, Shionogi > plans to expedite the application process based on these clinical > results, with the intention of submitting a new drug application > (NDA) within the current fiscal year. > > In the process of developing this drug, Shionogi has received many > earnest inquiries from patients with IPF and their families regarding > the extent of progress of development, and urgent requests for the > medication. > > With this situation in mind, Shionogi intends to do its best to > expedite submission and approval for S-7701 in order to offer the > quickest possible relief to patients suffering from this disease. > > For further information, contact: > Public Relations Unit > Shionogi & Co., Ltd. > (Osaka) > Tel: +81-6-6209-7885 Fax: +81-6-6229-9596 > (Tokyo) > Tel: +81-3-3406-8164 Fax: +81-3-3406-8099> > > > > > __________________________________________________>

[Guest guest]

Louise...you don't mention an OLbio but I know it's mandatory for the study. That is the reason I did not join when I was given the chance. I also did not want to be in an 18 month study...keep EVERY appt or perhaps be dropped and on and on. I guess I'm just not that noble. I'll leave that stuff to Santa, who wants to gift others!

Love to you. Sher ipf 5-06

"Don't worry about tomorrow, God is already there"

Re: Pirfenidone Study......Good News!

For those that are interested, Stanford medical Center is doing a double blind study regarding this drug, I have applied to be included, now awaiting to see if I meet the criteria to be included?

The side effects appear to tbe minimal compared to some of the chemo drugs?

Sure hope it works.

Louise/ipf/96/Calif.Joyce <janne5303> wrote:

http://www.medadnews.com/News/index.cfm?articleid=402015 Shionogi: Results of Phase III Clinical Trials of the Idiopathic Pulmonary Fibrosis Treatment S-7701 OSAKA, December 22, 2006 — Shionogi & Co., Ltd. (Head Office: Osaka; President: Motozo Shiono! ) today announced that it has achieved the primary objectives of Phase III clinical trials for the idiopathic pulmonary fibrosis treatment S-7701 (generic name: pirfenidone), which the Company is developing in Japan under a license from U.S.-based Marnac, Inc. and KDL, Inc., Tokyo. Idiopathic pulmonary fibrosis (IPF) is a medical condition of unknown etiology with poor prognosis in which progressive fibrosis of the alveolar walls produces irreversible "honeycomb lung"*. In general, restrictive impairment (reduction of vital capacity (VC) and total lung capacity (TLC)) is evident. As the symptom (fibrosis of the alveolar walls) progresses, gas exchange in the lungs (exchange of oxygen and carbon dioxide) becomes difficult. In some cases, oxygen therapy becomes necessary. Because of its severity, IPF is designated as a "specified disease" (in other words, an intractable disorder). Under development as a treatment for IPF, S-7701 has been designated as an orphan drug (a drug used to treat a rare disease) by the Pharmaceuticals and Medical Devices Agency. *Honeycomb lung: A high-resolution CT scan of the lung yields a honeycomb pattern. In the Phase III clinical trials for this drug with VC change (from before commencement of treatment to 52 weeks after commencing treatment) as the primary endpoint, both high and low doses of the drug (600mgl per day, three times a day and 400mgl per day, three times a day, respectively), significantly inhibited worsening of the condition compared with a placebo. While continuing to conduct further analysis and study, Shionogi plans to expedite the application process based on these clinical results, with the intention of submitting a new drug application (NDA) within the current fiscal year. In the process of developing this drug, Shionogi has received many earnest inquiries from patients with IPF and their families regarding the extent of progress of development, and urgent requests for the medication. With this situation in mind, Shionogi intends to do its best to expedite submission and approval for S-7701 in order to offer the quickest possible relief to patients suffering from this disease. For further information, contact: Public Relations Unit Shionogi & Co., Ltd. (Osaka) Tel: +81-6-6209-7885 Fax: +81-6-6229-9596 (Tokyo) Tel: +81-3-3406-8164 Fax: +81-3-3406-8099

__________________________________________________

[Guest guest]

What is a OLbio? Please let me know? Thanks, LouiseSher K Bauman wrote: Louise...you don't mention an OLbio but I know it's mandatory for the study. That is the reason I did not join when I was given the chance. I also did not want to be in an 18 month study...keep EVERY appt or perhaps be dropped and on and on. I guess I'm just not that noble. I'll leave that stuff to Santa, who wants to gift others! Love to you. Sher ipf 5-06 "Don't worry about tomorrow, God is already there" Re: Pirfenidone Study......Good News! For those that are interested, Stanford medical Center is doing a double blind study regarding this drug, I have applied to be included, now

awaiting to see if I meet the criteria to be included? The side effects appear to tbe minimal compared to some of the chemo drugs? Sure hope it works. Louise/ipf/96/Calif.Joyce <janne5303> wrote: http://www.medadnews.com/News/index.cfm?articleid=402015 Shionogi: Results of Phase III Clinical Trials of the Idiopathic Pulmonary Fibrosis Treatment S-7701 OSAKA, December 22, 2006 — Shionogi & Co., Ltd. (Head Office: Osaka; President: Motozo Shiono! ) today announced that it has achieved the primary objectives of Phase III clinical trials for the idiopathic

pulmonary fibrosis treatment S-7701 (generic name: pirfenidone), which the Company is developing in Japan under a license from U.S.-based Marnac, Inc. and KDL, Inc., Tokyo. Idiopathic pulmonary fibrosis (IPF) is a medical condition of unknown etiology with poor prognosis in which progressive fibrosis of the alveolar walls produces irreversible "honeycomb lung"*. In general, restrictive impairment (reduction of vital capacity (VC) and total lung capacity (TLC)) is evident. As the symptom (fibrosis of the alveolar walls) progresses, gas exchange in the lungs (exchange of oxygen and carbon dioxide) becomes difficult. In some cases, oxygen therapy becomes necessary. Because of its severity, IPF is designated as a "specified disease" (in other words, an intractable disorder). Under development as a treatment for IPF, S-7701 has been designated as an orphan drug (a drug used to treat a rare disease) by the

Pharmaceuticals and Medical Devices Agency. *Honeycomb lung: A high-resolution CT scan of the lung yields a honeycomb pattern. In the Phase III clinical trials for this drug with VC change (from before commencement of treatment to 52 weeks after commencing treatment) as the primary endpoint, both high and low doses of the drug (600mgl per day, three times a day and 400mgl per day, three times a day, respectively), significantly inhibited worsening of the condition compared with a placebo. While continuing to conduct further analysis and study, Shionogi plans to expedite the application process based on these clinical results, with the intention of submitting a new drug application (NDA) within the current fiscal year. In the process of developing this drug, Shionogi has received many earnest inquiries from patients with IPF and their families regarding the extent of progress of development, and

urgent requests for the medication. With this situation in mind, Shionogi intends to do its best to expedite submission and approval for S-7701 in order to offer the quickest possible relief to patients suffering from this disease. For further information, contact: Public Relations Unit Shionogi & Co., Ltd. (Osaka) Tel: +81-6-6209-7885 Fax: +81-6-6229-9596 (Tokyo) Tel: +81-3-3406-8164 Fax: +81-3-3406-8099 __________________________________________________

[Guest guest]

Louise...OLbio is Open Lung Biopsy.

"Don't worry about tomorrow, God is already there"

Re: Pirfenidone Study......Good News!

For those that are interested, Stanford medical Center is doing a double blind study regarding this drug, I have applied to be included, now awaiting to see if I meet the criteria to be included?

The side effects appear to tbe minimal compared to some of the chemo drugs?

Sure hope it works.

Louise/ipf/96/Calif.Joyce <janne5303> wrote:

http://www.medadnews.com/News/index.cfm?articleid=402015 Shionogi: Results of Phase III Clinical Trials of the Idiopathic Pulmonary Fibrosis Treatment S-7701 OSAKA, December 22, 2006 — Shionogi & Co., Ltd. (Head Office: Osaka; President: Motozo Shiono! ) today announced that it has achieved the primary objectives of Phase III clinical trials for the idiopathic pulmonary fibrosis treatment S-7701 (generic name: pirfenidone), which the Company is developing in Japan under a license from U.S.-based Marnac, Inc. and KDL, Inc., Tokyo. Idiopathic pulmonary fibrosis (IPF) is a medical condition of unknown etiology with poor prognosis in which progressive fibrosis of the alveolar walls produces irreversible "honeycomb lung"*. In general, restrictive impairment (reduction of vital capacity (VC) and total lung capacity (TLC)) is evident. As the symptom (fibrosis of the alveolar walls) progresses, gas exchange in the lungs (exchange of oxygen and carbon dioxide) becomes difficult. In some cases, oxygen therapy becomes necessary. Because of its severity, IPF is designated as a "specified disease" (in other words, an intractable disorder). Under development as a treatment for IPF, S-7701 has been designated as an orphan drug (a drug used to treat a rare disease) by the Pharmaceuticals and Medical Devices Agency. *Honeycomb lung: A high-resolution CT scan of the lung yields a honeycomb pattern. In the Phase III clinical trials for this drug with VC change (from before commencement of treatment to 52 weeks after commencing treatment) as the primary endpoint, both high and low doses of the drug (600mgl per day, three times a day and 400mgl per day, three times a day, respectively), significantly inhibited worsening of the condition compared with a placebo. While continuing to conduct further analysis and study, Shionogi plans to expedite the application process based on these clinical results, with the intention of submitting a new drug application (NDA) within the current fiscal year. In the process of developing this drug, Shionogi has received many earnest inquiries from patients with IPF and their families regarding the extent of progress of development, and urgent requests for the medication. With this situation in mind, Shionogi intends to do its best to expedite submission and approval for S-7701 in order to offer the quickest possible relief to patients suffering from this disease. For further information, contact: Public Relations Unit Shionogi & Co., Ltd. (Osaka) Tel: +81-6-6209-7885 Fax: +81-6-6229-9596 (Tokyo) Tel: +81-3-3406-8164 Fax: +81-3-3406-8099

__________________________________________________

[Guest guest]

Apparently Stanford is not requiring the open lung biopsy, or at least from what I understand. I will know more by next month? Thanks for the info, LouiseSher K Bauman wrote: Louise...OLbio is Open Lung Biopsy. "Don't worry about tomorrow, God is already there" Re: Pirfenidone Study......Good News! For those that are interested, Stanford medical Center is doing a double blind study regarding this drug, I have applied to be included, now awaiting to see if I meet the criteria to be included? The side effects appear to tbe minimal compared to some of the chemo drugs? Sure hope it works. Louise/ipf/96/Calif.Joyce <janne5303> wrote: http://www.medadnews.com/News/index.cfm?articleid=402015 Shionogi: Results of Phase III Clinical Trials of the

Idiopathic Pulmonary Fibrosis Treatment S-7701 OSAKA, December 22, 2006 — Shionogi & Co., Ltd. (Head Office: Osaka; President: Motozo Shiono! ) today announced that it has achieved the primary objectives of Phase III clinical trials for the idiopathic pulmonary fibrosis treatment S-7701 (generic name: pirfenidone), which the Company is developing in Japan under a license from U.S.-based Marnac, Inc. and KDL, Inc., Tokyo. Idiopathic pulmonary fibrosis (IPF) is a medical condition of unknown etiology with poor prognosis in which progressive fibrosis of the alveolar walls produces irreversible "honeycomb lung"*. In general, restrictive impairment (reduction of vital capacity (VC) and total lung capacity (TLC)) is evident. As the symptom (fibrosis of the alveolar walls) progresses, gas exchange in the lungs (exchange of oxygen and carbon dioxide) becomes difficult. In some cases, oxygen therapy

becomes necessary. Because of its severity, IPF is designated as a "specified disease" (in other words, an intractable disorder). Under development as a treatment for IPF, S-7701 has been designated as an orphan drug (a drug used to treat a rare disease) by the Pharmaceuticals and Medical Devices Agency. *Honeycomb lung: A high-resolution CT scan of the lung yields a honeycomb pattern. In the Phase III clinical trials for this drug with VC change (from before commencement of treatment to 52 weeks after commencing treatment) as the primary endpoint, both high and low doses of the drug (600mgl per day, three times a day and 400mgl per day, three times a day, respectively), significantly inhibited worsening of the condition compared with a placebo. While continuing to conduct further analysis and study, Shionogi plans to expedite the application process based on these clinical results, with the intention

of submitting a new drug application (NDA) within the current fiscal year. In the process of developing this drug, Shionogi has received many earnest inquiries from patients with IPF and their families regarding the extent of progress of development, and urgent requests for the medication. With this situation in mind, Shionogi intends to do its best to expedite submission and approval for S-7701 in order to offer the quickest possible relief to patients suffering from this disease. For further information, contact: Public Relations Unit Shionogi & Co., Ltd. (Osaka) Tel: +81-6-6209-7885 Fax: +81-6-6229-9596 (Tokyo) Tel: +81-3-3406-8164 Fax: +81-3-3406-8099 __________________________________________________