SOURCE: Omni Bio Pharmaceutical, Inc.

Omni Bio Pharmaceutical, Inc.

December 09, 2014 09:00 ET

Omni Bio Announces Encouraging Clinical Data for Use of Alpha-1 Antitrypsin (AAT) in Steroid-Resistant Graft Versus Host Disease

Interim Phase 1/2 Data Presented at American Society of Hematology

FORT COLLINS, CO--(Marketwired - Dec 9, 2014) - Omni Bio Pharmaceutical, Inc. (OTC PINK: OMBP) ("Omni Bio"), an emerging biopharmaceutical company focused on revolutionizing the treatment of immune-mediated inflammatory diseases, announced today the presentation of interim clinical data demonstrating the ability of plasma-derived alpha-1 antitrypsin (AAT) to reduce inflammation and promote healing of damaged tissues in patients with graft-versus-host disease (GvHD), a common and potentially life-threatening complication following bone marrow transplantation. The positive interim results support continued clinical studies of this novel approach to treating GvHD and also highlight the potential value of Omni Bio's novel, recombinant AAT candidate, AAT-Fc, currently in preclinical development.

Data from the first seven patients to complete the Phase 1/2 study were presented yesterday in a poster session at the 56th annual meeting of the American Society of Hematology in San Francisco by Omni Bio's academic collaborators from the University of Washington and the Fred Hutchinson Cancer Research Center. Following allogeneic stem cell transplants to treat leukemic malignancies, the patients in the study all developed severe acute GvHD symptoms (severe diarrhea, loss of mucosal lining in the gut) but did not respond satisfactorily to standard of treatment including high dose steroids. The patients then received intravenous doses of plasma-derived AAT every other day for a total of 8 doses (15 days) in an attempt to alleviate their GvHD symptoms.

Key results were as follows:

  • Five of seven patients formed normal stools and were considered treatment successes; none required further treatment for GvHD (with median follow-up of 8 months)
  • Endoscopic evaluation of all patients one week post-treatment showed re-epithelialization and repair of the bowel wall
  • Key anti-inflammatory and immune modulatory proteins (IL-10, IL-1Ra and IL-15) increased in all patients and various markers of tissue damage were reduced
  • Plasma AAT levels increased 80% from pre to post treatment
  • One patient with complicated liver GvHD required additional therapy and died

The investigators concluded that the administration of AAT as a safe salvage therapy for gut GvHD is feasible without clinically relevant toxicity. Stool sampling showed a decrease in intestinal AAT clearance and endoscopic evaluation confirmed healing of the bowel mucosa. The overall findings suggest that further evaluation of AAT as treatment for steroid refractory GvHD, or as first line therapy, is warranted.

Charles A. Dinarello, M.D., Chief Scientific Officer of Omni Bio and co-author of the presentation, stated, "We are very pleased with the interim results from this innovative treatment, which demonstrates AAT's initial efficacy as a safe rescue treatment for steroid-refractory GvHD. Current rescue treatments for these patients are highly toxic. In contrast, AAT was well-tolerated by all the patients in the study. There is no question about the need for more effective treatments for this life-threatening condition. More effective therapy may also encourage greater use of bone marrow transplantation for treating leukemia in the aging population. We expect the ongoing study to teach us more about the benefits of AAT not only as a rescue treatment but also as first line therapy. Randomized trials are being planned."

Bruce Schneider, Ph.D., Chief Executive Officer of Omni Bio, added, "We are proud to support clinical studies that highlight the broad potential benefit of AAT therapy in mitigating immune-mediated inflammatory diseases. Positive outcomes in these studies demonstrate the robust tissue-protective attributes of AAT, and by extension accelerate and de-risk the development pathway for our recombinant AAT-Fc candidate."

About the Phase 1/2 Study (Interim results)
Seven patients (3 female, 4 male), between 35 and 59 years old, with hematologic malignancies were enrolled in the first and second cohort. All patients received cyclosporine and MMF for GvHD prophylaxis. Acute GvHD of grades III-IV developed at 37 to 93 days, and treatment with systemic methylprednisolone, 2 mg/kg/day was instituted. Patients showing no clinically satisfactory responses after 5 days were given AAT (Glassia™) at 90mg/kg i.v. on day 1, followed by 30mg/kg (first cohort) or 60mg/kg (second cohort) every other day for a total of 8 doses (15 days).

About Omni Bio Pharmaceutical, Inc.
Omni Bio Pharmaceutical, Inc. ("Omni Bio") is an emerging biopharmaceutical company focused on revolutionizing the treatment of immune-mediated inflammatory disease. The Company's technology platform, AAT-Fc, is a recombinant version of plasma-derived alpha-1 antitrypsin (p-AAT), a naturally occurring human protein that is currently commercialized as an intravenous supplementation therapy for AAT-deficient individuals. Omni Bio seeks to capitalize on emerging scientific evidence of AAT's fundamental role in mediating multiple anti-inflammatory and tissue protective pathways by developing first-in-class therapeutics to address a broad array of new clinical opportunities.

Omni Bio's recombinant AAT-Fc can offer several potential advantages over current p-AAT products, including superior potency, longer half-life, improved safety and easy-to-administer subcutaneous dosing, as well as significantly enhanced manufacturing scalability. Omni Bio intends to exploit AAT-Fc's enhanced product potential to address multiple, high-value immune-mediated inflammatory disease indications, such as Type 1 diabetes, graft versus host disease and chronic gout. The Company holds broad intellectual property covering both recombinant and plasma-derived AAT for these and other indications.

For more information, please visit http://www.omnibiopharma.com.

Forward-Looking Statements
 
This press release contains forward-looking statements that reflect the Company's current expectations as of the date of this press release, and involve certain risks and uncertainties that could cause actual results to differ materially from those anticipated in these forward- looking statements. Factors that could cause future results to materially differ from forward-looking statements include the risks described in Omni Bio Pharmaceutical, Inc.'s Form 10-K for the fiscal year ended March 31, 2014 and other reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statements. The Company's further development is highly dependent on raising capital to support its activities, future medical and research developments and market acceptance, and other risks that are outside of the Company's control.

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