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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?


To: Roy Glen who wrote (11660)11/25/1997 5:52:00 AM
From: Henry Niman  Respond to of 32384
 
Roy, The study sounds like the PFE trial, but I think that the number of participating sites is much larger. PFE has indicated that they plan to file an NDA next year. LGND would get milestone payments for filing and approval. Once Droloxifene goes on sale, LGND would get 1% of worldwide sales until Droloxifene is approved for another indication (such as osteoporosis). Then the rate would increase to 3% of all sales, including breast canccer. Here's a description of the trial:
Summary: Study of an investigational hormonal treatment,
DROLOXIFENE, for advanced breast cancer

This is a phase III multi-center, randomized, double-blind trial being conducted in patients
with locally advanced or metastatic breast cancer. The objective of the study is to
determine if an investigational drug, DROLOXIFENE, will arrest or reverse tumor spread
when compared with the standard therapy, tamoxifen. Study drug is taken orally once each
day and provided free by the sponsor. Patients will be treated until there is evidence of
progressive disease or, once the blind is broken, until the drug they are taking is
commercially available.

Eligible patients must meet at least the following criteria:

Be a pre- or post-menopausal woman
Have locally advanced or metastatic breast cancer (cancer has spread to the chest
wall, skin, bone or internal organs). The cancer can be locally advanced or
metastatic at the time of diagnosis, or it can be recurrent cancer, appearing after
adjuvant hormonal treatment or adjuvant chemotherapy
Have a tumor that tests positive for estrogen and/or progesterone receptors
Have had no thromboembolic events (problems with abnormal blood clot formation)
in past 6 months
Not currently be taking anticoagulants or daily high-dose steroids
If adjuvant hormonal or chemotherapy was given, it must have terminated more
than one year ago (for hormonal) or more than four weeks ago (for chemo)
Must not have had any hormonal or chemotherapy for advanced disease
Must not have any severe or uncontrolled disease (other than the breast cancer)
Be able to swallow oral tablets

Contact the center below for more information.

Contact:

Peggy Kosonen, RN, OCN, Study Contact
Hematology/Oncology P.C.

Stamford, CT 06902
Telephone: 203-323-8944