New Data Suggest That Cialis (IC351) May Help Men with Erectile
Dysfunction Improve Sexual Function Lilly ICOS Releases Phase II Data at 9th
World Meeting on Impotence Research
INDIANAPOLIS, Nov 28, 2000 /PRNewswire via COMTEX/ -- Data from a large Phase
II clinical trial show that up to 88 percent of men taking an investigational
oral treatment for erectile dysfunction (ED) -- Cialis(TM) (IC351), a new-
generation phosphodiesterase type 5 (PDE5) inhibitor -- reported improved
erections relative to placebo. These findings, presented today at the 9th World
Meeting on Impotence Research in Perth, Australia, show that Cialis increased
the percentage of successful and satisfying intercourse attempts for both men
and their partners.
"Cialis is a potent and highly selective PDE5 inhibitor that was well tolerated
at a range of doses in this study, with mild to moderate side effects reported
that diminished over time," said Dr. Gerald Brock of St. Joseph's Health Centre,
Department of Urology, Ontario, Canada. "It may provide a promising therapeutic
option to help men improve their sexual function."
Cialis studied in broad group of men
Brock, a leading researcher in erectile dysfunction, presented Phase II data
from a clinical study that examined the safety and efficacy of on-demand Cialis
treatment in 212 men with mild-to-severe ED. Men were randomized to receive
either placebo or Cialis at doses up to 25 mg over an eight-week period. Up to
88 percent of men taking Cialis reported significantly improved erections
compared with 28 percent of those taking placebo.
"What is important about this study was that Cialis was studied in a broad group
of men with erectile dysfunction," said Brock. "We saw improved results in men
suffering from erectile dysfunction of varying severity and causes, such as
diabetes, and importantly we did not see serious side effects."
The results presented at this meeting confirm the results of two previous Phase
II multi-center placebo-controlled trials. In these studies, different doses of
Cialis and different dosing regimens were examined. These studies demonstrate
consistent, statistically significant improvement in erectile function.
Collectively these studies enrolled nearly 700 men with ED of varying severity
and causes.
The most frequent treatment-related adverse events reported were headache,
myalgia (muscle pain), dyspepsia (stomach upset following meals) and back pain.
These events were dose-related, generally mild-to-moderate, and tended to abate
with continued treatment. A global Phase III investigational clinical program
for Cialis is currently underway.
To evaluate Cialis' effect versus placebo, researchers compared baseline scores
from the International Index of Erectile Function (IIEF) questionnaire and
sexual encounter profile (SEP) diaries of ED sufferers and their partners. These
measurements determine the ability of men to obtain and maintain an erection in
order to have satisfying intercourse and achieve orgasm. Data obtained from SEP
diaries showed increased reports from both men and their partners of successful
and satisfying intercourse attempts.
Erectile dysfunction is defined as the consistent inability to attain and
maintain an erection sufficient for sexual intercourse. It affects an estimated
70 million men and their partners worldwide with many cases caused by physical
conditions, including various cardiovascular diseases and diabetes.
In-Vitro Selectivity Data Presented
Additionally, results from comparative in-vitro (test tube) research were
presented at this meeting, with results suggesting that Cialis was more
selective than sildenafil at targeting PDE5 receptor sites. PDE5 is an important
enzyme involved in controlling blood flow to the penis. When PDE5 is inhibited,
natural sexual stimuli produce a more pronounced effect, facilitating the
ability of men with ED to attain and maintain an erection.
This research showed that Cialis affected the PDE5 receptor sites without
interfering appreciably with the actions of other known PDEs that play essential
roles in the action of cells in different parts of the body (for example, those
found is various organs and tissues such as the brain, heart, kidney or eyes).
"This selectivity research suggests that you would need approximately 700 times
more Cialis to inhibit the action of PDE6, the phosphodiesterase found in the
retina of the eye, than would be needed to inhibit PDE5 to a similar extent,"
said Brock.
About Lilly ICOS
Lilly ICOS LLC, a joint venture between ICOS Corporation (Nasdaq: ICOS) and Eli
Lilly and Company (NYSE: LLY), is developing Cialis, which is currently under
investigation for the treatment of both male erectile dysfunction and female
sexual dysfunction (FSD). Eli Lilly and Company, a leading innovation-driven
corporation, is developing a growing portfolio of best-in-class pharmaceutical
products by applying the latest research from its own worldwide laboratories and
from collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and information
-- for some of the world's most urgent medical needs. ICOS is a product-driven
company that has expertise in both protein-based and small molecule
therapeutics. ICOS, located in Bothell, Wash., combines capabilities in
molecular, cellular and structural biology, high throughput drug screening,
medicinal chemistry and genomics to develop highly innovative products with
significant commercial potential. The company applies its integrated approach to
specific target areas where it has expertise. ICOS believes this strategy
increases the chances of successfully developing commercial products. ICOS'
disease targets include erectile dysfunction, female sexual dysfunction, sepsis,
pulmonary hypertension and other cardiovascular diseases.
This press release contains forward-looking statements about the potential of
the investigational compound Cialis in treating male erectile dysfunction that
reflect management's current beliefs. However, as with any pharmaceutical under
development, there are risks and uncertainties in the process of development and
regulatory review. There are no guarantees that future clinical trials will
confirm the preliminary results reported in this release or that the product
will receive regulatory approvals or prove to be commercially successful. For
further discussion of these and other risks and uncertainties, see the U.S.
Securities and Exchange Commission filings of ICOS and Lilly.
SOURCE Lilly ICOS LLC |
