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Results Published in the Journal 'Cancer' Demonstrate that Oral Talactoferrin Alfa is Active as Monotherapy in Previously Treated Patients with Metastatic Renal Cell Carcinoma

HOUSTON, July 1 /PRNewswire/ -- Agennix Incorporated today announced the publication of final results from a Phase 2 monotherapy trial with talactoferrin alfa in patients who had failed previous treatment for advanced or metastatic renal cell carcinoma (RCC). Results from the study, which were reported in the July 1 issue of the journal 'Cancer' (volume 113, number 1), demonstrate that talactoferrin is active in RCC, has a favorable toxicity profile, and is a promising candidate for further study in this disease.

The talactoferrin monotherapy single arm trial was conducted at six leading U.S. centers and enrolled 44 patients who had all failed prior treatment for advanced or metastatic RCC. The study met the pre-defined target of demonstrating an improvement in the fourteen week progression-free survival (PFS) rate relative to published results in this population. Additional evidence of anti-cancer activity included the occurrence of partial responses and an apparent increase in median PFS and median overall survival (OS) relative to published results. As in previous studies with talactoferrin, the drug was well tolerated.

"The results seen with talactoferrin monotherapy in this Phase 2 trial are promising," said Dr. Eric Jonasch, Assistant Professor, MD Anderson Cancer Center, Houston, Texas, and the first author of the study. "The trial results indicate that additional studies of talactoferrin in patients with RCC are warranted either as a single agent or in combination with one of the newer targeted therapies. Previously conducted preclinical studies combining talactoferrin with sunitinib are supportive for examining this combination in a randomized trial in patients with advanced or metastatic RCC."

Agennix also announced the receipt of Orphan Medicinal Product designation from the European Medicines Agency (EMEA) for RCC. The Company had previously announced receipt of Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the same indication.

Final Phase 2 Study Results

The Phase 2 talactoferrin monotherapy trial was an open label, 44-patient, single arm trial conducted at six leading U.S. sites. To be eligible, patients with histologically confirmed metastatic or unresectable RCC had to have disease progression after being treated with at least one prior regimen of systemic therapy. Computed tomography (CT) scan documentation of disease progression following the most recent therapy was required. Talactoferrin was administered at a dose of 1.5 grams twice a day in 14-week cycles (12 weeks on, two weeks off) for up to four cycles or until disease progression. The study's co-primary endpoints were to detect an increase in the 14-week progression-free survival (PFS) rate from 20% to 40% or a 12.5% response rate, either of which were considered to be clinically significant. In a Phase 2 trial of Avastin in second line RCC patients, the placebo arm had a 4-month PFS rate of 20%, and was chosen as the historical reference.

All 44 patients were included in the intent-to-treat (ITT) population. The study met the pre-defined target with a 14-week PFS rate of 59% (p<0.0001 for comparison to 20%). The response rate was 4.5%, with 70.5% of patients demonstrating stable disease for at least 8 weeks. The disease control (complete or partial response + stable disease) rate was 75%. The median PFS was 6.4 months. The median overall survival (OS) was 21.1 months, and the 1 year survival rate was 77%. Talactoferrin was well tolerated with no significant hematological, renal or hepatic toxicities reported. In addition, there were no drug related serious adverse events.

About EMEA Orphan Medicinal Product Designation

The Regulation on Orphan Medicinal Products in the European Union (EU) provides incentives for companies developing and marketing therapies for rare diseases, defined as those affecting fewer than five in 10,000 people in the EU. The Regulation grants companies with Orphan Medicinal Product designation market exclusivity for a particular indication for a period of ten years following Marketing Authorization Approval by the EMEA. Orphan Medicinal Product designation also facilitates the drug development process by providing companies with protocol assistance, clinical trial support, direct access to the Centralized Procedure, grant funding for research, and waiver or reduction of application fees.

The Company had previously received Orphan Drug designation for RCC from the U.S. FDA.

"We are very pleased that the EMEA recognizes that our lead product, talactoferrin alfa, has potential as a treatment for patients with RCC, and we are planning additional trials in this indication including a randomized, placebo-controlled Phase 2b trial of talactoferrin in combination with a standard first-line therapy," said Rajesh Malik, M.D., Chief Medical Officer of Agennix.

About the Planned Phase 2b First-Line Combination Therapy RCC Trial

Building on the results of the positive Phase 2 trial with single agent talactoferrin, preparations are underway to conduct a Phase 2b trial in 200-250 previously untreated patients with advanced or metastatic RCC as part of a first-line combination therapy regimen. Patients will be randomly assigned to receive a standard therapy plus either oral talactoferrin or placebo. The primary endpoint will be assessment of PFS, with additional endpoints including response rate, OS, and safety.

About Talactoferrin Alfa

Talactoferrin, a novel dendritic cell recruiter and activator (DCRA), is a unique recombinant form of human lactoferrin, an important immunomodulatory protein.

In 1988, scientists at Baylor College of Medicine, Houston, Texas, discovered a way to produce this protein in the laboratory, thus paving the way for testing its potential to help fight serious diseases that cause enormous suffering worldwide.

Lactoferrin, found in the highest concentration in milk, is expressed throughout the body in immune cells and on all body surfaces exposed to the external environment. Lactoferrin plays an important role in helping to establish the immune system, including the Gut Associated Lymphoid Tissue (GALT), in infants. Talactoferrin is produced in Aspergillus niger, a filamentous fungus, and is structurally identical to native human lactoferrin in all material respects, differing only in its glycosylation.

Talactoferrin is an orally administered protein that mediates its activity through the gut and the GALT -- the largest lymphoid organ in the body. It acts through a novel mechanism of dendritic cell recruitment and activation. Following oral administration, talactoferrin is transported by the M-cells into the small intestinal Peyer's Patches, where it recruits circulating immature dendritic cells bearing tumor antigens to the GALT and induces their maturation. DC maturation in the presence of tumor antigens and lymphoid effector cells induces a strong systemic innate and adaptive immune response mediated by anti-cancer Natural Killer (NK) cells, CD8+ lymphocytes and NK-T cells. This results in the activation of tumor-draining lymph nodes, cellular infiltration of distant tumors and tumor-cell death. Mounting the initial immune response in the GALT -- away from the primary tumor and using a physiologically important pathway -- minimizes the effect of the cancer's local immunosuppressive defenses.

About Renal Cell Carcinoma (RCC) RCC is the most common type of kidney cancer, accounting for approximately 90 percent of kidney tumors. In the United States, RCC affects over 40,000 patients per year, and is responsible for close to 13,000 deaths. Kidney cancer is uncommon under age 45, and its incidence is highest between the ages of 55 and 84.

Once RCC is metastatic, it is difficult to treat, and median survival is between one and two years. A number of different modalities are available for the treatment of metastatic RCC, including immunotherapy, chemotherapy, targeted therapy, and/or radiation therapy. Some of the targeted therapies include multi-targeted tyrosine kinase inhibitors such as sunitinib (Sutent) and sorafenib (Nexavar), inhibitors of the mammalian target of rapamycin, such as temsirolimus (Torisel), and the anti-vascular endothelial growth factor (VEGF) antibody, bevacizumab (Avastin). Although each agent can provide some benefit in a subset of patients, complete response is exceedingly rare, and most patients with metastatic RCC die of their disease. Additional therapy is clearly needed.

About Agennix

Agennix is a private biotechnology company developing a first-in-class molecule with activity in several types of cancer and in other indications with unmet medical needs. This molecule, talactoferrin, is a targeted dendritic cell recruiter and activator with a novel mechanism of action. Agennix is preparing to initiate Phase 3 trials in two NSCLC indications (talactoferrin in combination with chemotherapy in previously untreated patients and talactoferrin monotherapy in patients who have failed two or more previous therapies), a Phase 2b trial in renal cell cancer, and Phase 2 trials in other indications. Talactoferrin's potential advantages in NSCLC and in other tumor types include its promising anti-tumor activity, its well tolerated safety profile including a reduction of some chemotherapy toxicities, its oral route of administration, and its apparent usefulness in multiple tumor types both as a single agent and in combination with other drugs. Agennix retains all of the commercial and economic rights to talactoferrin for all indications worldwide, and has strong global intellectual property protection for talactoferrin.

More information about Agennix is available on the Company's web site at

SOURCE Agennix Incorporated
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