From the Ultrafem thread:
To: Stuart Fine (186 )
From: Fred Ayres
Wednesday, Oct 15 1997 12:38PM EST
Reply #187 of 193
Stuart,
Although probably not related to the recent decline in stock price, Procept (PRCTD)
announced a second patent for their PRO2000 vaginal topical microbicide. Recall
UFEM has their own product, BufferGel, in the pipeline and it is currently undergoing
Phase I Trials. I think it is clear that the Instead SoftCup is not catching on in the
marketplace. UFEM has sparingly little to work with at the moment and introduction of
a topical microbicide for women may not be enough. Their time-frame is approximately
3 years to market.
Significant Competing Products in Clinical Trial for STD Prevention
-------------------------------------------------------------------
Vaginal Contraceptive Film (Apothecus))
Protectaid Sponge (Axcan)
Advantage 24 (Columbia Laboratories)
PRO2000 (Procept)
[215.2] Phase I Study of a New Vaginal Microbicide, Buffergel:
Rationale and Clinical Data
Kenneth H. Mayer for the HIVNET Vaginal Microbicide Protocol Team, Brown
University, Providence, RI
Introduction: HIV and other STD pathogens (e.g. HSV-2, syphilis and gonorrhea) are
rapidly inactivated by exposure
to acidic pH. The human vagina usually has a pH of 3.5 to 4.5, but this is neutralized
by semen or genital tract infections
that diminish lactobacilli. As part of the NIAID-funded HIV Network for Prevention
Trials, a study was designed to
evaluate the safety and acceptability of a novel microbicide strategy, BufferGel.
BufferGel is a carbopol, a negatively
charged high molecular weight polymer, which is not absorbed and can neutralize twice
its own volume of base buffers
like semen.
Project Description: In order to prepare for future efficacy trials, a Phase I study of
BufferGel has been designed to
evaluate the safety and acceptability of this product used once daily for 2 weeks in 10
abstinent women, and if tolerated,
then twice daily for two weeks in this population. The protocol underwent internal and
external, independent peer
review, and began enrollment in December 1996. Twenty low-risk women are
currently being enrolled in the Greater
Providence Area. The primary safety/toxicity endpoints are: Grade 3 or higher
hematology, liver or renal function
toxicities; macroscopic evidence of damage to the vagina, cervix and external genitalia
including: ulceration, abrasion,
severe erythema and/or severe edema. The secondary acceptability endpoints address
elements of willingness to use the
product as well as compliance with the protocol regimen. If the abstinent women
tolerate the product, the next 10
women studied will be in stable monogamous relationships and undergo the same
dosing schedule.
Findings and Implications: Data collection is scheduled to be completed by mid 1997.
Data on the primary and
secondary endpoints identified above will be presented. The maintenance of an acidic
vaginal pH is a potential defense
mechanism that may limit heterosexual HIV transmission. If BufferGel is found to be
safe and well-tolerated in low-risk
U.S. women, further studies of this product overseas and among high-risk U.S. women
will be undertaken
To: Stuart Fine (188 )
From: Fred Ayres
Friday, Oct 24 1997 2:57AM EST
Reply #190 of 193
Stuart,
At what stage of development is your microbicide?
The companies I mentioned with the exception of Procept and Ultrafem use
Nonoxynol-9 as an active ingredient. The recent N-9 trial in Cameroon of VCF (N-9
Vaginal Contraceptive Film) suggest that N-9 may not be useful for the prevention of
STDs (the test was not conclusive). I am not willing to suggest all N-9 products will fail
at STD prevention. The product Advantage-24, which contains N-9, is currently in
Phase III clinical trials. Of the entire family of potential STD products, Advantage-24 is
the most likely to achieve NDA status and be first to market. Long term I expect only
a handful of products to make it to market-- Adavantage-24, PRO-2000, and
possibly BufferGel.
Fred
To: Fred Ayres (190 )
From: Douglas
Monday, Nov 3 1997 8:15AM EST
Reply #194 of 194
Fred,
I have been following Procept for a couple of years and find no mention of Procept
and Nonoxynol-9. It seems to me that Procept is making progress on distancing
themselves from Nonoxynol-9 and having a new product. Please let me know where
you found the connection. Thanks. You are probably already aware of the Procept
thread, it has some good postings.
Doug. |
