NEW YORK, NY--(Marketwire - January 05, 2010) -
China Aoxing Pharmaceutical Company, Inc.
) ("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
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.