[MOL] Re: MGI Pharma Announces Initiation of Phase II Human... [02839] Medicine On Line


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[MOL] Re: MGI Pharma Announces Initiation of Phase II Human...



In a message dated 98-07-21 07:38:30 EDT, you write:

<< Subj:	MGI Pharma Announces Initiation of Phase II Human...
 Date:	98-07-21 07:38:30 EDT
 From:	AOL News
 BCC:	LINHILLIS
 
 MGI Pharma Announces Initiation of Phase II Human Testing With MGI 114, A
Potential Anticancer Compound
 
 MINNEAPOLIS, July 21 /PRNewswire/ -- MGI PHARMA, INC. (Nasdaq: MOGN), a
pharmaceutical company, today announced that it has initiated its Phase II
human clinical program with MGI 114, a potential anticancer compound, with the
treatment of hormone-refractory prostate cancer patients in an exploratory
Phase II trial.  This study will initially evaluate approximately 14 patients
with hormone-refractory prostate cancer and could be expanded to include 16
additional evaluable patients if positive responses are noted in the first
group of patients.  The primary objective of Phase II clinical testing is
efficacy, whereas safety and tolerance are the primary objectives for Phase I
testing.
 
 Hormone-refractory prostate cancer was selected as one of the first tumor
types for Phase II testing with MGI 114 due to the excellent antitumor
activity observed in animal studies, as well as the significant need for an
effective treatment for these difficult-to-treat tumors.  In American men,
prostate cancer is the most commonly diagnosed malignancy and the second
leading cause of cancer death.  The CA Cancer Journal estimates that about
40,000 American men die annually from prostate cancer, primarily with hormone-
refractory disease.
 
 Charles N. Blitzer, MGI PHARMA's president and chief executive officer, said,
"We are very excited to initiate our Phase II testing of MGI 114, which will
begin to define how effective the drug is in treating specific tumor types in
humans.  Our Phase I studies showed that the drug is well tolerated by
patients at dose levels associated with antitumor effects in animals.  We hope
this translates into greater chances of proving efficacy in humans as we move
the drug into a series of Phase II trials."
 
 In May, MGI PHARMA announced that it would initiate three Phase II human
studies with MGI 114 this year.  In addition to the hormone-refractory
prostate study, MGI PHARMA plans to begin Phase II studies in ovarian and
pancreatic cancer patients.  The National Cancer Institute (NCI) will also
conduct several Phase II studies with MGI 114, including two studies each in
breast, colon, renal, ovarian and non-small cell lung cancer, and one study in
cervical cancer.  The NCI also plans to conduct a Phase I human safety study
in pediatric cancer patients with solid tumors.
 
 MGI 114 is the lead compound of a family of promising antitumor agents called
the acylfulvenes.  Preclinical tests indicate that MGI 114 has several
potential advantages over other antitumor compounds, including: 1) a mechanism
of action that is distinct from other chemotherapy drugs; 2) activity against
tumor cell lines that are resistant to standard antitumor therapies; and 3) a
synergistic effect against tumor cells when combined with certain approved
drugs.
 
 Previous MGI 114 Studies  
 
 Preclinical data on MGI 114's potential against prostate cancer was presented
at the European Organization for Research and Treatment of Cancer/National
Cancer Institute (EORTC/NCI) meeting, held in Amsterdam, The Netherlands, June
16-19, 1998.  In one animal study where DU-145 human prostate tumors were
implanted in mice, five of eight animals showed complete elimination of the
tumors.  In a second animal study using PC-3 human prostate tumors implanted
in mice, all ten mice included in the study showed a partial shrinkage of
their tumor (i.e., greater than 50 percent shrinkage), with a mean shrinkage
of 72.5 percent.  Previous animal and laboratory tests with human tumor cells
have also shown that MGI 114 is active against a variety of solid tumor cell
lines including breast, lung, colon, prostate, ovarian, melanoma, gastric,
squamous cell and pancreatic tumors.
 
 Since December 1995, MGI PHARMA has been testing MGI 114 in Phase I human
safety studies designed to identify the highest dose of MGI 114 that can be
safely administered to adults with solid tumors.  In these ongoing studies,
more than 40 patients have received MGI 114 to date.  Current results indicate
that significant doses of the drug can be administered to humans before a
dose-limiting degree of bone marrow suppression is observed.  Other drug-
related toxicities reported in these studies include nausea, vomiting,
fatigue, facial flushing, phlebitis (venous inflammation), and reversible
kidney effects.
 
 MGI PHARMA is a pharmaceutical company, headquartered in Minnetonka, Minn.,
that acquires, develops and markets innovative products for niche medical
markets of unmet medical need.  The company currently markets Salagen(R)
Tablets (pilocarpine hydrochloride), INFeD(R) (iron dextran injection 50mg/ml)
and Didronel(R) I.V. Infusion (etidronate disodium) in the United States.
 
 This press release contains forward-looking statements that may include
statements regarding intent, belief or current expectations of the company and
its management.  These forward-looking statements are not guarantees of future
performance and involve a number of risks and uncertainties that may cause the
company's actual future prospects to differ materially from the results
discussed in these statements.  Factors that might cause such differences
include, but are not limited to, the ability of MGI 114 to be proven safe and
effective in humans as a chemotherapy agent, and other risks and uncertainties
detailed from time to time in the company's filings with the Securities and
Exchange Commission.
  >>
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