Some news! Is anyone still following this stock? It is boring, but they continue to make progress and I see no reason to sell.
FOR IMMEDIATE RELEASE
StressGen Initiates Second Clinical Trial for HspE7 In Healthy Volunteers
- Data to be used to launch development of HspE7 in new indications -
Victoria, British Columbia, July 13, 1999 Ð StressGen Biotechnologies Corp.
(TSE:SSB) today announced that it has begun a Phase I clinical trial of
HspE7 (product number SGN-00101), in male and female healthy volunteers.
This study is designed to rapidly provide safety data on HspE7 to facilitate
the expansion of the Company's clinical development of HspE7 for conditions
caused by the human papillomavirus (HPV). HPV infection has been identified
as the major causative agent of several conditions including cervical
dysplasia, anal dysplasia and, cervical and anal cancer. StressGen began a
Phase I clinical trial of HspE7 in cervical dysplasia in February. Safety
data from the new study will allow the Company to pursue its planned Phase
II trial in anal dysplasia.
As a secondary endpoint of the new Phase I study, the Company will evaluate
the ability of HspE7 to engender a cellular immune response. Activation of
the cellular arm of the immune system is believed to be necessary for the
elimination of cells infected by viruses like HPV.
"This trial is enrolling rapidly and we expect to have data available by the
end of the third quarter of this year," said Richard M. Glickman,
StressGenùs President and CEO. "The safety data from this trial will be
useful for our planned Phase II trial in AIN, which we intend to begin soon
after the safety analysis of the Phase I study."
Healthy Volunteer Trial Design
This Phase I trial is a randomized, placebo-controlled, double-blinded study
in male and female healthy volunteers. It consists of 24 patients and is
being conducted at a single site in the USA.
Background on Anal Intraepithelia Neoplasia (AIN or Anal Dysplasia)
HPV infects over one-half of the adult population. Certain papilloma
viruses, spread by sexual contact to infect the anogenital areas, cause
precancerous conditions and cancer. Anal intraepithelia neoplasia is
characterized by the presence of abnormal cells that may precede anal
cancer. Like cervical dysplasia, AIN is principally caused by HPV. Certain
high risk groups appear to have a much greater incidence of this disease
than the population at large, but anal dysplasia is being recognized more
and more frequently and some expert physicians believe the incidence is
growing. Advanced disease often is treated with surgery, from which
significant complications may result.
Background On HspE7
HspE7, a recombinant fusion product, is composed of heat shock protein 65
(Hsp65) from M. bovis BCG and the protein E7 from HPV16. As a member of the
family of stress proteins, Hsp65 is known to elicit a powerful immune
response. The E7 protein is derived from the human papillomavirus (HPV) and
is involved in the malignant transformation of cervical and anal epithelial
cells. E7 is a tumour-specific antigen and thus represents a precise target
for the immune system.
StressGen Biotechnologies Corp. is a biopharmaceutical company developing
innovative immunotherapy products to treat cancer and prevent infectious
disease. The Companyùs core technology capitalizes on the ability of stress
proteins to activate the bodyùs immune system to recognize and fight
disease. Through its Biochemical Division, StressGen is also an
internationally recognized supplier of stress protein, protein trafficking,
apoptosis and signal transduction research reagents. |
