Aeterna Zentaris Inc.'s (AEZS) (AEZ.TO) phase II clinical trial of its lead oncology compound, Zoptarelin doxorubicin (formerly AEZS-108) in Castration and taxane Resistant Prostate Cancer has met the primary endpoint of Clinical Benefit and demonstrated good tolerability.
The primary endpoint of Clinical Benefit is defined as remaining progression-free by RECIST and Prostate Specific Antigen (PSA) after treatment for over 12 weeks.
The company noted that the phase II results in prostate cancer, as well as prior positive phase 2 results in endometrial and ovarian cancer, are further demonstration of the potential of Zoptarelin doxorubicin in a variety of cancer indications for both men and women.
AEZS closed Monday's trading 13.39% higher at $0.09.
BioMarin Pharmaceutical Inc. (BMRN) has enrolled the first patient in a phase 1/2 trial for BMN 270, an investigational gene therapy for the treatment of patients with hemophilia A.
The study will evaluate the safety and efficacy of BMN 270 gene therapy in up to 12 patients with severe Hemophilia A. The primary endpoints are to assess the safety of a single intravenous administration of a recombinant AAV, human-coagulation Factor VIII vector and to determine the change from baseline of Factor VIII expression level at 16 weeks after infusion. Patients will be monitored for safety for five years.
BMRN closed Monday's trading at $99.38, down 8.57%.
The FDA has granted Fast Track designation for BioTime Inc.'s (BTX) OpRegen, a cell-based therapeutic product candidate consisting of retinal pigment epithelial cells designed to block the progression of the severe dry-form of age-related macular degeneration, a leading cause of blindness in an aging population.
A phase I/IIa dose-escalation study evaluating the safety and efficacy of OpRegen for geographic atrophy, the severe stage of the dry form of age-related macular degeneration is underway. The first patient was treated earlier this year and interim data are expected in early 2016.
BTX closed Monday's trading at $2.94, down 16%.
Eli Lilly and Co.'s (LLY) phase II study of CYRAMZA in combination with docetaxel met its primary endpoint, demonstrating a statistically significant increase in progression-free survival in bladder cancer.
According to the trial results, the median progression-free survival was 5.4 months on the CYRAMZA-docetaxel combination arm compared to 2.8 months for patients treated with docetaxel alone, and 1.6 months for those treated with icrucumab and docetaxel.
Another phase III trial, dubbed RANGE, which is evaluating CYRAMZA and docetaxel versus placebo and docetaxel in patients with locally advanced or unresectable metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy is underway.
CYRAMZA is already approved for gastric cancer, non-small cell lung cancer and colorectal cancer. The drug raked in sales of $87.7 million in the second quarter of 2015.
LLY closed Monday's trading at $79.74, down 5.14%.
Esperion Therapeutics Inc. (ESPR) announced that a cardiovascular outcomes trial of its investigational cholesterol-lowering drug ETC-1002 in patients on maximally tolerated statin therapy who require additional LDL-C lowering needs to be completed before approval.
Last month, the company had said that the approval of ETC-1002 in the heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease patient populations will not require the completion of a cardiovascular outcomes trial prior to approval.
Esperion intends to initiate a global long-term safety study for ETC-1002 by the end of 2015.
The company plans to conduct multiple phase III clinical trials of ETC-1002 that will separately evaluate patients with statin intolerance, as well as patients who are inadequately treated despite maximally tolerated statin therapy.
ESPR closed Monday's trading at $35.09, down 10.85%. In after hours, the stock fell another 10.69% to $31.34.
Intrexon Corp. (XON) and ZIOPHARM Oncology Inc. (ZIOP) have formed a new collaboration, known as Exclusive Channel Collaboration, to pursue cellular therapy approaches to autoimmune disorder like graft-versus-host disease.
The collaboration will focus on addressing the underlying pathologies of graft-versus-host disease through engineered cell platforms to express and deliver interleukin-2 (IL-2), a cytokine critical for modulation of the immune system.
Under the terms of the collaboration, Intrexon will receive a technology access fee of $10 million in cash and reimbursement for all research and development costs. The agreement also provides for equal sharing of operating profits.
XON closed Monday's trading at $31.78, down 19.22%. In after hours, the stock was up 1.92% to $32.39.
Ocular Therapeutix Inc. (OCUL) has submitted a New Drug Application to the FDA for DEXTENZA 0.4mg Intracanalicular Depot for the treatment of ocular pain following ophthalmic surgery.
As part of label expansion strategy for DEXTENZA to include treatment of post-surgical inflammation, the company is expected to commence a phase III in this indication later this year.
OCUL closed Monday's trading at $14.23, down 7.78%.
Revance Therapeutics Inc. (RVNC) has commenced dosing patients in its pivotal phase III study to evaluate the safety and efficacy of RT001, an investigational topical gel or the treatment of lateral canthal lines, or crow's feet.
The study will enroll a total of up to 450 adult patients at multiple sites in the United States and will be randomized 1:1 to a single treatment of either RT001 topical gel or placebo. The company plans to release interim results from this phase III study in the first half of 2016.
RVNC closed Monday's trading at $26.27, down 2.74%.
Titan Pharmaceuticals Inc. (TTNP.OB) announced that the resubmitted New Drug Application for Probuphine, an investigational subdermal implant for the maintenance treatment of opioid dependence in adult patients, has been accepted for review by the FDA. The regulatory agency's decision is slated for February 27, 2016.
A Complete Response Letter to the NDA for Probuphine was issued by the FDA in April 2013, with the regulatory agency requesting additional data supporting the efficacy of Probuphine.
The resubmitted NDA for Probuphine includes results from a phase III double-blind, double-dummy clinical study. The study met the pre-specified primary endpoint of non-inferiority, as well as all secondary efficacy endpoints.
The company will effect a 1-for-5.5 reverse stock split at the open of business on September 29, 2015.
TTNP.OB closed Monday's trading at $0.66, up 2.33%.
Zosano Pharma Corp. (ZSAN) has decided to discontinue development of its Daily ZP-PTH treatment for severe osteoporosis and has terminated the exclusive agreement with Eli Lilly and Co. (LLY) that was signed last December.
The decision to discontinue Daily ZP-PTH program was based on recent feedback from Japanese regulatory authorities, which would have required additional studies that would have likely delayed commercialization in Japan by approximately one year, as well as an overall assessment and prioritization of company resources towards the most promising commercial opportunities.
However, the company will resume development of its Weekly ZP-PTH product, which completed a phase 1 clinical trial in Australia in early 2014. A pre-IND meeting with the FDA to discuss the clinical trial design for a planned Phase 2 and Phase 3 trial of Weekly ZP-PTH was held last July, and the company is now planning to initiate a Phase 2 trial of Weekly ZP-PTH in the first half of 2016.
For the near term, the company has the following catalysts to offer.
The results from a phase II trial of ZP-Glucagon product in severe hypoglycemia are scheduled to be announced within the next few weeks and results from a Phase 1 trial of ZP-Triptan product in migraine are expected to be reported before the end of 2015.
ZSAN closed Monday's trading at $6.32, down 4.68%.
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