Friday, August 02, 2013 12:06:05 PM
AEZS, $1.42 initated a postion here. Recently completed an offering & initiated Phase 3 trial, appears to have bottomed per the chart:
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Recent Phase 3 News:
Aeterna Zentaris: First Patient Dosed for Phase 3 Registration Trial in Endometrial Cancer with Zoptarelin Doxorubicin (AEZS-108)
7:30a ET July 31, 2013 (PR NewsWire) All amounts are in U.S. dollars (unless otherwise noted)
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX:AEZ) (the "Company") today announced that the first patient has been recruited and dosed for the Phase 3 ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with endometrial cancer resistant to platinum/taxane-based chemotherapy.
"We have reached another important milestone in the final clinical development stage for zoptarelin doxorubicin (AEZS-108) in treating endometrial cancer. Efforts are now focused on pursuing patient recruitment as swiftly as possible", stated David Dodd, President and CEO of Aeterna Zentaris. "This compound's innovative targeted approach potentially offers a much needed novel treatment option for women with endometrial cancer and it provides the Company with a significant market opportunity."
The Study
This is an open-label, randomized, multicenter Phase3 trial to be conducted in over 120 sites in NorthAmerica, Europe, Israel and other countries under a Special Protocol Assessment, comparing zoptarelin doxorubicin (AEZS-108) with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. Lead investigators are David Scott Miller, MD, from the University of Texas Southwestern Medical Center, in Dallas, Texas, and Hani Gabra, MD, from the Imperial College London Hammersmith Campus in London, England. The trial will involve approximately 500 patients and the primary efficacy endpoint is improvement in median Overall Survival.
Selected as the contract clinical development organization, Ergomed will also assume 30% (up to $10million) of the clinical and regulatory costs for this trial.
Details for this trial are available at www.clinicaltrials.gov (NCT01767155).
About Zoptarelin Doxorubicin (AEZS-108)
Zoptarelin doxorubicin (AEZS-108) represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin (AEZS-108) is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a Phase3 trial in endometrial cancer under a Special Protocol Assessment, while zoptarelin doxorubicin (AEZS-108) is also in Phase 2 trials for triple-negative breast cancer, prostate cancer and bladder cancer. Aeterna Zentaris owns the worldwide rights to zoptarelin doxorubicin (AEZS-108).
About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. Approximately one in 30 women is diagnosed with endometrial cancer every year. According to the American Cancer Society, an estimated 49,560 new cases of endometrial cancer in the U.S., and 35,600 in Europe, are expected during 2013, with about 20% of recurring disease.
Recent Offering closing News:
Aeterna Zentaris Completes $7.8 Million Registered Direct Offering
6:00p ET July 30, 2013 (PR NewsWire) (All amounts are in US dollars)
Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZ) (the "Company") announced today that it has completed its previously announced registered direct offering of $7.8million of units comprised of common shares and common share purchase warrants to certain institutional investors. Net proceeds from this offering, after deducting placement agent fees and other offering expenses, total approximately $7 million. All of the securities were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used to continue to fund the Company's ongoing drug development activities, primarily for the advancement of its zoptarelin doxorubicin (AEZS-108) program, secondly for its macimorelin acetate (AEZS-130) program, as well as for general corporate purposes and working capital.
Burrill Securities LLC acted as the exclusive placement agent for the transaction.
As of July 30, 2013 and after issuing 5.2 million common shares at the closing of this offering, the Company had approximately 31.2 million common shares issued and outstanding, without giving effect to or assuming the exercise of any outstanding warrants.
A shelf registration statement relating to the common shares and warrants issued in the offering (and the common shares issuable upon exercise of the warrants) has been filed with the Securities and Exchange Commission (the "SEC") and has been declared effective. A prospectus supplement relating to the offering was filed with the SEC. Copies of the prospectus supplement and accompanying prospectus may be obtained directly from Aeterna Zentaris Inc., 1405 du Parc-Technologique Boulevard, Quebec City, Canada G1P 4P5. This announcement is neither an offer to sell nor a solicitation of an offer to buy any of Aeterna Zentaris' common shares or warrants. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
Recent Phase 3 News:
Aeterna Zentaris: First Patient Dosed for Phase 3 Registration Trial in Endometrial Cancer with Zoptarelin Doxorubicin (AEZS-108)
7:30a ET July 31, 2013 (PR NewsWire) All amounts are in U.S. dollars (unless otherwise noted)
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX:AEZ) (the "Company") today announced that the first patient has been recruited and dosed for the Phase 3 ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with endometrial cancer resistant to platinum/taxane-based chemotherapy.
"We have reached another important milestone in the final clinical development stage for zoptarelin doxorubicin (AEZS-108) in treating endometrial cancer. Efforts are now focused on pursuing patient recruitment as swiftly as possible", stated David Dodd, President and CEO of Aeterna Zentaris. "This compound's innovative targeted approach potentially offers a much needed novel treatment option for women with endometrial cancer and it provides the Company with a significant market opportunity."
The Study
This is an open-label, randomized, multicenter Phase3 trial to be conducted in over 120 sites in NorthAmerica, Europe, Israel and other countries under a Special Protocol Assessment, comparing zoptarelin doxorubicin (AEZS-108) with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. Lead investigators are David Scott Miller, MD, from the University of Texas Southwestern Medical Center, in Dallas, Texas, and Hani Gabra, MD, from the Imperial College London Hammersmith Campus in London, England. The trial will involve approximately 500 patients and the primary efficacy endpoint is improvement in median Overall Survival.
Selected as the contract clinical development organization, Ergomed will also assume 30% (up to $10million) of the clinical and regulatory costs for this trial.
Details for this trial are available at www.clinicaltrials.gov (NCT01767155).
About Zoptarelin Doxorubicin (AEZS-108)
Zoptarelin doxorubicin (AEZS-108) represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin (AEZS-108) is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a Phase3 trial in endometrial cancer under a Special Protocol Assessment, while zoptarelin doxorubicin (AEZS-108) is also in Phase 2 trials for triple-negative breast cancer, prostate cancer and bladder cancer. Aeterna Zentaris owns the worldwide rights to zoptarelin doxorubicin (AEZS-108).
About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. Approximately one in 30 women is diagnosed with endometrial cancer every year. According to the American Cancer Society, an estimated 49,560 new cases of endometrial cancer in the U.S., and 35,600 in Europe, are expected during 2013, with about 20% of recurring disease.
Recent Offering closing News:
Aeterna Zentaris Completes $7.8 Million Registered Direct Offering
6:00p ET July 30, 2013 (PR NewsWire) (All amounts are in US dollars)
Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZ) (the "Company") announced today that it has completed its previously announced registered direct offering of $7.8million of units comprised of common shares and common share purchase warrants to certain institutional investors. Net proceeds from this offering, after deducting placement agent fees and other offering expenses, total approximately $7 million. All of the securities were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used to continue to fund the Company's ongoing drug development activities, primarily for the advancement of its zoptarelin doxorubicin (AEZS-108) program, secondly for its macimorelin acetate (AEZS-130) program, as well as for general corporate purposes and working capital.
Burrill Securities LLC acted as the exclusive placement agent for the transaction.
As of July 30, 2013 and after issuing 5.2 million common shares at the closing of this offering, the Company had approximately 31.2 million common shares issued and outstanding, without giving effect to or assuming the exercise of any outstanding warrants.
A shelf registration statement relating to the common shares and warrants issued in the offering (and the common shares issuable upon exercise of the warrants) has been filed with the Securities and Exchange Commission (the "SEC") and has been declared effective. A prospectus supplement relating to the offering was filed with the SEC. Copies of the prospectus supplement and accompanying prospectus may be obtained directly from Aeterna Zentaris Inc., 1405 du Parc-Technologique Boulevard, Quebec City, Canada G1P 4P5. This announcement is neither an offer to sell nor a solicitation of an offer to buy any of Aeterna Zentaris' common shares or warrants. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
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