HIV Protection Trial Halted Due to Increase Risk of...HIV!
by H.S. Ayoub
BioHealth Investor.com
Shares of Canadian firm Polydex Pharmaceuticals (POLYXF) absolutely sank more than 50% on Wednesday as the company announced that phase III trials of Ushercell, a topical microbicide gel for the prevention of HIV infections in women, were halted internationally.
CONRAD, a reproductive health research organization dedicated to the prevention of AIDS and other sexually transmitted diseases in women and men, halted the trials of Ushercell in South Africa, Benin, Uganda, and India, after women taking part in the late stage trials exhibited an increased risk of HIV infection compared to the placebo group. Family Health International also halted a phase III trial of Ushercell in Nigeria following the preliminary data presented by the CONRAD trials.
This came as a surpise to Polydex officials as numerous earlier trials showed strong and positive data. Ushercell, which is a Cellulose Sulfate based topical gel, had consistently shown strong safety data through 11 trials and 500 total participants. The earlier trials mostly tested the gel's safety profile and contraceptive potential however.
President and CEO George Usher declared that Polydex will continue to investigate Ushercell's contraceptive potential, and will work together with CONRAD to determine the cause of the high incidence of HIV infection in the trials.
Polydex stock ended regular hours trading at $3 a share, down 55%. Shares dropped a further 14% to $2.59 in after-hours trading.
RELATED READING:
- Company Press Release
- VIVUS Looking to Profit from Obesity and Sexual Dysfunction
_____________________
BioHealth Investor.com
Shares of Canadian firm Polydex Pharmaceuticals (POLYXF) absolutely sank more than 50% on Wednesday as the company announced that phase III trials of Ushercell, a topical microbicide gel for the prevention of HIV infections in women, were halted internationally.
CONRAD, a reproductive health research organization dedicated to the prevention of AIDS and other sexually transmitted diseases in women and men, halted the trials of Ushercell in South Africa, Benin, Uganda, and India, after women taking part in the late stage trials exhibited an increased risk of HIV infection compared to the placebo group. Family Health International also halted a phase III trial of Ushercell in Nigeria following the preliminary data presented by the CONRAD trials.
This came as a surpise to Polydex officials as numerous earlier trials showed strong and positive data. Ushercell, which is a Cellulose Sulfate based topical gel, had consistently shown strong safety data through 11 trials and 500 total participants. The earlier trials mostly tested the gel's safety profile and contraceptive potential however.
President and CEO George Usher declared that Polydex will continue to investigate Ushercell's contraceptive potential, and will work together with CONRAD to determine the cause of the high incidence of HIV infection in the trials.
Polydex stock ended regular hours trading at $3 a share, down 55%. Shares dropped a further 14% to $2.59 in after-hours trading.
RELATED READING:
- Company Press Release
- VIVUS Looking to Profit from Obesity and Sexual Dysfunction
_____________________
posted by Nico at
9:49 PM
1 Comments:
Investors looking to participate in microbicides should look into Indevus (IDEV) and Pro2000.
The investment story at IDEV is intriguing enough (Santurna XR, Nebido, Pagoclone, etc.) that most shareholders have put little to no value on Pro2000.
But, if microbicides for HIV interests you, Pro2000 is well into their African Phase III (paid for by NGO). Prior to starting the study, the FDA agreed that statistically significant results from this 25,000 woman study would be sufficient for filing an NDA.
Kitcat
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