China Aoxing Pharmaceutical Company Announces Successful Completion of Phase II Clinical Study of Novel Menstrual Pain Drug
January 05 2010 - 7:30AM
Marketwired
China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China
Aoxing"), a pharmaceutical company specializing in research,
development, manufacturing and distribution of narcotic and
pain-management products, today announced that it completed Phase
II clinical study for oral TJSL capsules, a novel investigational
drug to treat primary dysmenorrhea ("PD") , or menstrual pain, in
adult women. Top-line results from this study are expected to be
announced in the coming weeks.
The Phase II clinical study was a 12-week, multi-center,
randomized, double-blind and placebo-controlled study to evaluate
the safety and efficacy of TJSL capsules among 240 patients with
primary dysmenorrheal. Subjects were between 18 and 35 years old
enrolled at four leading university teaching hospitals in
metropolitan areas of China. Subjects received TJSL capsules or
placebos, three times a day for ten days, starting at one week
prior to each menstrual cycle or period. The primary endpoints used
to evaluate the efficacy were the sum of pain score differences,
measured by visual analogue scale ("VAS"), as well as symptom
improvement during menstruation over three menstrual cycles. The
size of the trials was powered to achieve statistical significance
between the treatment arm versus control arm.
"We are very pleased with the results to date and the progress
made in TJSL program since we acquired the product last year,"
stated Zhenjiang Yue, Chairman and the CEO of China Aoxing. "We
look forward to announcing the results of this trial and initiating
Phase III clinical study in the coming weeks. We believe that TJSL
has the potential to become a major player in the treatment of
menstrual pain and enables us to serve yet another greatly
underserved market segment in pain management."
TJSL is a capsule form of selected herbal medicines. Its
mechanism of action deserves further investigation, but appears to
be its capability of reversing the effects of endometrial
prostaglandin, reducing the frequency and strength of uterine
contraction as well as providing pain relief, based on in vivo
study.
The prevalence rates of PD among women are from 60 to 90
percent. It is estimated that 64% of women in China purchase
menstrual pain drugs on a regular basis. The market size of a
healthcare product to address menstrual pain is estimated at $3
billion per year in China.
About Primary Dysmenorrhea ("PD")
Primary dysmenorrhea is defined as recurrent, cramping pain in
the lower abdomen occurring just before or during menstruation, in
the absence of demonstrable pelvic disease, such as endometriosis.
Prevalence rates are as high as 90 percent. Initial presentation of
PD typically occurs in adolescence. It is a common cause of
absenteeism and reduced quality of life in women. Women with PD
have increased production of endometrial prostaglandin, resulting
in increased uterine tone and stronger, more frequent uterine
contractions.
Pharmacological interventions available in the market include
non-steroidal anti-inflammatory drugs (NSAIDs), hormonal
contraceptives, levonorgestrel intrauterine contraception and
tocolytics.
About TJSL Capsules
TJSL was originated by Professor X. Tian, a well known
gynecologist in China. The drug is composed of several herbal
medicines optimized based on her 40 years of medical research in
treating PD. The drug has been used empirically by over 1,000
patients who suffered from PD. From in vivo studies, the drug was
capable of reversing the effects of endometrial prostaglandin,
reducing the frequency and strength of uterine contraction as well
as providing pain relief.
About China Aoxing Pharmaceutical Company, Inc.
China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) is a
pharmaceutical company specializing in research, development,
manufacturing and distribution of a variety of narcotics and
pain-management products. It has a strategic alliance with American
Oriental Bioengineering, Inc. (NYSE: AOB). Headquartered in
Shijiazhuang City, the pharmaceutical capital of China, outside of
Beijing, China Aoxing has China's largest and the most advanced
manufacturing facility for highly regulated narcotic medicines,
addressing a very under-served and fast-growing market in China.
Its facility is one of the few GMP facilities licensed for
narcotics medicines. The Company is working closely with the
Chinese government and SFDA to assure the strictly regulated
availability to medical professionals of its narcotic drugs and
pain medicines throughout China.
Statements made in this press release are forward-looking and
are made pursuant to the safe harbor provisions of the Securities
Litigation Reform Act of 1995. Such statements involve risks and
uncertainties that may cause actual results to differ materially
from those set forth in these statements. The economic,
competitive, governmental, technological and other risk factors
identified in the Company's filings with the Securities and
Exchange Commission, including the Form 10-KSB for the year ended
June 30, 2009, may cause actual results or events to differ
materially from those described in the forward looking statements
in this press release. The Company undertakes no obligation to
publicly update or revise any forward-looking statements, whether
because of new information, future events, or otherwise.
Contact: Wei Zhang Vice President China Aoxing Pharmaceutical
Company, Inc. Email: chinaaoxing@gmail.com Telephone: 646 -
367-1747 Website: www.chinapainmed.com
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