Tue, Jan. 5, 1:16 PM
- Thinly traded micro cap Ampio Pharmaceuticals (NYSEMKT:AMPE) is up 20% on increased volume as traders take advantage of the company's distribution of most of its 11.6M shares of Aytu BioScience (OTCQX:AYTU) to shareholders. Today is the ex-distribution date to receive one share of Aytu for every five shares of Ampio common stock owned.
- Aytu BioScience is a commercial stage firm focused on urology. It currently sells two products, ProstaScint (capromab pendetide), a biologic for the detection of prostate cancer, and Primsol (trimethoprim oral solution), for the treatment of urinary tract infections. Its most advanced therapeutic is Phase 3-stage Zertane, for the treatment of premature ejaculation. The company was founded on certain assets previously owned by Ampio.
Oct. 14, 2015, 9:59 AM
- Ampio Pharmaceuticals' (AMPE +5.7%) recent meeting with the FDA's Transplant and Ophthalmology Division to discuss the results of its Phase 3 study, OptimEyes, that evaluated Optina (ultra-low dose danazol) in patients with diabetic macular edema (DME) does not appear to have gone as well as the company would have liked. Instead of clearing the way for a New Drug Application (NDA) under the abbreviated 505(b)2 pathway, the agency is requiring a confirmatory study in DME patients who have not responded to other drugs. If successful, Optina would qualify as a rescue mediation for patients with no treatment options.
- The new study will randomize ~80 subjects 1:1 to receive Optina or placebo for a maximum of 12 months. The efficacy of Optina will be not be compared to other anti-vascular endothelial growth factor (VEGF) medicines. The FDA will "consider" improved vision by Best Corrected Visual Acuity (BCVA) as an endpoint.
- Considering the study's duration, Ampio's NDA filing, assuming a positive outcome of the confirmatory study, who most likely occur sometime in 2017.
- Previously: Ampio up 28% premarket on selected Optina study results (May 21)
Sep. 22, 2015, 12:42 PM
Sep. 22, 2015, 9:21 AM
Sep. 22, 2015, 8:38 AM
- Ampio Pharmaceuticals (NYSEMKT:AMPE) commences a second Phase 3 clinical trial, called AP-003-B, assessing Ampion for the treatment of pain and inflammation due to osteoarthritis (OA) of the knee.
- The randomized, double-blind, placebo-controlled study will enroll 484 subjects with OA of knee. There will be a 28-day screening period followed by a 12-week participation period. Subjects will be randomized 1:1 to receive 4 mL Ampion or 4 mL placebo. The primary endpoint is the reduction in knee pain versus placebo.
- The results from AP-003-B and the earlier study, AP-003-A, will provide the data supporting a Biologics License Application (BLA) in the U.S., although the first trial failed to achieve its primary endpoint.
- Ampion is a low molecular weight fraction of human serum albumin (HSA). Its main ingredient is an immunomodulatory molecule derived from HSA called aspartyl-alanyl diketopiperazine (DA-DKP). DA-DKP is believed to reduce inflammation by suppressing pro-inflammatory cytokine production in T cells.
- Shares are up 23% premarket on robust volume.
- Previously: Ampio Pharma off 58% premarket on failed trial results (April 20)
Jun. 22, 2015, 9:18 AM
Jun. 9, 2015, 9:17 AM
Jun. 4, 2015, 9:14 AM
May 22, 2015, 9:16 AM
May 21, 2015, 9:16 AM
May 21, 2015, 8:42 AM
- Micro cap Ampio Pharmaceuticals (NYSEMKT:AMPE) is up 28% premarket on robust volume in response to its announcement of positive results from a Phase 3 study, OptimEyes, assessing orally administered Optina (danazol) in 355 adult patients with diabetic macular edema (DME).
- 53% (n=188/355) of trial participants were unresponsive (refractory) to intraocular injection therapy. This group showed a +6.2 letter improvement in visual acuity over the three-month study period (p<0.001). In the remaining 47% (n=167/355), participants who were unable or unwilling to have eye injections (n = unknown) showed a +3.1 letter improvement over the same period (p=0.04). The placebo arm, as expected, failed to demonstrate a significant increase in visual acuity.
- The company neglects to disclose the results for the entire trial (n=355) or the 47% segment (n=167).
- Ampio plans to continue its analysis and present the data to the FDA. After receiving guidance, it will disclose more detailed information. Translation: the study, in its totality, failed to achieve its efficacy endpoint.
Apr. 20, 2015, 12:47 PM
Apr. 20, 2015, 9:32 AM
- Micro cap Ampio Pharmaceuticals (NYSEMKT:AMPE) craters 58% premarket on robust volume in response to its announcement that the Phase 3 clinical trial evaluating AP008 for the reduction in pain associated with osteoarthritis of the knee failed to reach its primary endpoint compared to placebo due to a larger-than-expected range of results in the placebo arm. The company is analyzing the data and will host a conference call in the near future to discuss the results.
Apr. 20, 2015, 9:17 AM
Mar. 23, 2015, 5:37 PM
Feb. 25, 2015, 9:24 AM
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company, which focuses on the development of therapies to treat prevalent inflammatory conditions. Its product pipeline includes new uses for approved drugs and new molecular entities for important therapeutic areas, including metabolic disease,... More
Industry: Drug Manufacturers - Other
Country: United States
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