GREENWOOD VILLAGE, CA, USA I February 27, 2013 I Ampio Pharmaceuticals, Inc. (AMPE) announced oral dosing of the first patient in a 505(b)(2) clinical trial of the investigational drug Optina in diabetic macular edema. The trial will evaluate Optina™ in adults with recent onset diabetic macular edema. Last year, the FDA granted Optina™ 505(b)(2) status and drugs designated under this pathway can be approved on a single trial.
Michael Macaluso, Chairman and CEO of Ampio, commented "We dosed the first patient with oral Optina™’ today. We believe that Optina has the potential to successfully treat patients afflicted with diabetic macular edema and satisfy a large unmet clinical need with a successful oral therapy. Based on the encouraging results from the Canadian study, we are very excited about Optina™’s potential to allow diabetic patients to avoid direct injections into the eye, a requirement of all other treatment regimens."
The multicenter trial is designed to evaluate the safety and efficacy of oral Optina™ compared with placebo given over a period of 12 weeks in adult patients with DME. A total of 450 patients are expected to enroll. Patients are randomized to receive one of two oral doses of Optina™ (0.5mg per BMI and 1.0mg per BMI per day) or placebo. After patients have completed 4 weeks of initial treatment, an interim analysis will occur to determine the best dose of Optina™. Following the 12 week active treatment period, there will be a further 4 week washout period to determine regression of treatment effect. The primary endpoint is improvement in visual acuity (VA), defined by responder status, compared to placebo. Secondary endpoints are 1) measurements of changes in VA and central macular thickness (CMT) in treated patients compared to placebo and, 2) safety and tolerability of the two Optina™ doses. Following treatment and washout, patients will be assessed for vision regression and a 12 week open label extension study will be offered to evaluate the duration of effect of the optimal dose.
About Optina™
Optina™ is a drug based on a low dose of the weak androgen, low-molecular-weight, very lipophilic steroid danazol. Oral administration of low dose danazol to patients with DME is safe with no evidence of serious adverse events. Ampio’s in vitro data suggest that danazol has a biphasic effect on endothelial cells: At low doses, danazol decreases vascular leakage, while at higher concentrations an increase in vascular permeability is observed. This biphasic effect was supported by the efficacy of danazol in vivo at various BMIs. From Ampio’s previously announced results, Optina™ appears to reduce DME in a BMI dosage-adjusted manner and appears to trend toward improved visual acuity and seems to be safe with few, if any, side effects.1, 2
About Diabetic Macular Edema
Diabetic Macular Edema (DME) is a swelling of the retina in diabetic patients due to leaking of fluid from blood vessels within the macula. The macula is the part of the eye responsible for sharp central vision. There are approximately 26 million people in the United States with diabetes and DME can occur in both Type 1 and Type 2 diabetes. Up to 10% of diabetics will develop DME during their lifetime and up to 75,000 new cases of DME are estimated to occur each year in the United States3. Current treatments include anti-VEGF drugs, corticosteroid-based regiments, and laser surgery that helps seal the leaky blood vessels. Drug delivery by injection into the vitreous of the eye is a limitation of these new treatments because of the potential complications due to repeated injections into the eye such as infection, pain, hemorrhage and increased intraocular pressure.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company focused on the rapid development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. It aims to provide medicines to improve the health and quality of life of patients with minimal side effects. Ampio is developing compounds that decrease inflammation by 1) inhibition of specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level or 2) activation of a specific phosphatase or depletion of the available phosphate needed for the inflammation process. For more information visit: www.ampiopharma.com.
SOURCE: Ampio Pharmaceuticals
Post Views: 131
GREENWOOD VILLAGE, CA, USA I February 27, 2013 I Ampio Pharmaceuticals, Inc. (AMPE) announced oral dosing of the first patient in a 505(b)(2) clinical trial of the investigational drug Optina in diabetic macular edema. The trial will evaluate Optina™ in adults with recent onset diabetic macular edema. Last year, the FDA granted Optina™ 505(b)(2) status and drugs designated under this pathway can be approved on a single trial.
Michael Macaluso, Chairman and CEO of Ampio, commented "We dosed the first patient with oral Optina™’ today. We believe that Optina has the potential to successfully treat patients afflicted with diabetic macular edema and satisfy a large unmet clinical need with a successful oral therapy. Based on the encouraging results from the Canadian study, we are very excited about Optina™’s potential to allow diabetic patients to avoid direct injections into the eye, a requirement of all other treatment regimens."
The multicenter trial is designed to evaluate the safety and efficacy of oral Optina™ compared with placebo given over a period of 12 weeks in adult patients with DME. A total of 450 patients are expected to enroll. Patients are randomized to receive one of two oral doses of Optina™ (0.5mg per BMI and 1.0mg per BMI per day) or placebo. After patients have completed 4 weeks of initial treatment, an interim analysis will occur to determine the best dose of Optina™. Following the 12 week active treatment period, there will be a further 4 week washout period to determine regression of treatment effect. The primary endpoint is improvement in visual acuity (VA), defined by responder status, compared to placebo. Secondary endpoints are 1) measurements of changes in VA and central macular thickness (CMT) in treated patients compared to placebo and, 2) safety and tolerability of the two Optina™ doses. Following treatment and washout, patients will be assessed for vision regression and a 12 week open label extension study will be offered to evaluate the duration of effect of the optimal dose.
About Optina™
Optina™ is a drug based on a low dose of the weak androgen, low-molecular-weight, very lipophilic steroid danazol. Oral administration of low dose danazol to patients with DME is safe with no evidence of serious adverse events. Ampio’s in vitro data suggest that danazol has a biphasic effect on endothelial cells: At low doses, danazol decreases vascular leakage, while at higher concentrations an increase in vascular permeability is observed. This biphasic effect was supported by the efficacy of danazol in vivo at various BMIs. From Ampio’s previously announced results, Optina™ appears to reduce DME in a BMI dosage-adjusted manner and appears to trend toward improved visual acuity and seems to be safe with few, if any, side effects.1, 2
About Diabetic Macular Edema
Diabetic Macular Edema (DME) is a swelling of the retina in diabetic patients due to leaking of fluid from blood vessels within the macula. The macula is the part of the eye responsible for sharp central vision. There are approximately 26 million people in the United States with diabetes and DME can occur in both Type 1 and Type 2 diabetes. Up to 10% of diabetics will develop DME during their lifetime and up to 75,000 new cases of DME are estimated to occur each year in the United States3. Current treatments include anti-VEGF drugs, corticosteroid-based regiments, and laser surgery that helps seal the leaky blood vessels. Drug delivery by injection into the vitreous of the eye is a limitation of these new treatments because of the potential complications due to repeated injections into the eye such as infection, pain, hemorrhage and increased intraocular pressure.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company focused on the rapid development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. It aims to provide medicines to improve the health and quality of life of patients with minimal side effects. Ampio is developing compounds that decrease inflammation by 1) inhibition of specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level or 2) activation of a specific phosphatase or depletion of the available phosphate needed for the inflammation process. For more information visit: www.ampiopharma.com.
SOURCE: Ampio Pharmaceuticals
Post Views: 131
