Agennix Incorporated today announced
results from a fourth positive Phase II trial with its lead molecule
talactoferrin alfa, an immunomodulatory protein with a novel mechanism of
action. This trial, which compared oral talactoferrin monotherapy to
placebo in patients with refractory non-small cell lung cancer (NSCLC), met
its primary endpoint of a statistically significant improvement in overall
survival. Secondary efficacy endpoints also showed improvement consistent
with the primary endpoint results. Oral talactoferrin was well tolerated in
this patient population with fewer adverse events observed in the
talactoferrin arm. These data were presented Saturday, June 2, at the 2007
American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Oral talactoferrin significantly improved overall survival in this
study. In the 100-patient intent-to-treat (ITT) population, median overall
survival was 62% higher in the talactoferrin group than in the placebo
group - 6.0 months versus 3.7 months, respectively (hazard ratio=0.69;
p=0.0476). In the 81-patient prospectively-defined evaluable population,
the median overall survival was 73% higher in the talactoferrin group than
in the placebo group - 7.6 months versus 4.4 months, respectively (hazard
ratio=0.60; p=0.0213). The six-month survival rate in the ITT population
was also significantly better in the talactoferrin group (49%) than the
placebo group (28%), p=0.0276. In addition, overall survival improvement
trends were consistent across subsets of patients grouped by prognostic
factors, including disease stage, performance status, and line of therapy.
In addition to improving overall survival, oral talactoferrin was well
tolerated by refractory NSCLC patients. Adverse events (AEs) were generally
mild, and no drug-related serious AEs were reported. In addition, there
were 28% fewer AEs and 51% fewer Grade 3/4/5 AEs in the talactoferrin group
relative to the placebo group (p=0.0015 and p=0.0005, respectively).
This was the second successful placebo-controlled trial with oral
talactoferrin in NSCLC. The first was in combination with first-line
chemotherapy. Preparations for Phase III trials with talactoferrin are
underway in both NSCLC indications: (i) first-line in combination with
chemotherapy, and (ii) single-agent treatment of patients with refractory
disease.
About the Study
In this Phase II single-agent study, 100 patients with stage IIIB/IV
NSCLC, whose cancer had progressed after first- or second-line
chemotherapy, were enrolled at 10 leading oncology centers in India and
randomized to receive standard supportive care plus either placebo (n=53)
or talactoferrin 1.5 g orally twice a day (n=47). Patients did not receive
any other anti- cancer therapy while on the trial. Treatment was
administered in 14-week cycles (12 weeks on, two weeks off) for up to three
cycles or until disease progression. The primary endpoint was overall
survival. All 100 patients were included in the ITT population. The 81
patients who had at least one CT scan after initiating treatment were
prospectively defined as the evaluable population.
About Talactoferrin Alfa
Talactoferrin alfa is a unique recombinant form of human lactoferrin,
an immunomodulatory protein. Talactoferrin acts by binding to specific
receptors found on target cells and inducing the production of key
immunomodulatory cytokines and chemokines. Orally administered
talactoferrin binds to enterocytes lining the upper gastrointestinal tract,
initiating an immunostimulatory cascade in the gut associated lymphoid
tissue. This results in the activation of both innate and adaptive
immunity, including recruitment and activation of dendritic cells, NK-T
cells and CD8+ lymphocytes. This is followed by systemic immunostimulation,
the activation of tumor-draining lymph nodes, and infiltration of distant
tumors by immune cells, which results in killing of the cancer cells.
Topically administered talactoferrin binds to keratinocytes and fibroblasts
and increases the local production of cytokines and chemokines critical to
wound healing.
Both oral and topical formulations of talactoferrin appear to be well
tolerated. Over 600 patients have been dosed with talactoferrin, including
patients who had exposure to talactoferrin lasting over two years, without
any drug-related serious AEs.
About NSCLC
In the United States, lung cancer is the second most frequent cancer in
both men (next to prostate cancer) and women (next to breast cancer). It
remains the major cause of cancer death, killing more people than breast
cancer, prostate cancer and colorectal cancer combined, and accounting for
almost 30% of all cancer-related deaths.
NSCLC accounts for approximately 80% of all new lung cancer cases, with
approximately 150,000 patients in the United States and 300,000 patients in
Europe diagnosed each year. Most patients diagnosed with NSCLC have late-
stage disease (Stage IIIB or IV), which is not surgically resectable. The
current U.S. standard of care for these patients is systemic chemotherapy.
Even with the available therapy, the five-year survival rate for these
patients is less than 3%.
About Agennix
Agennix is a private biotechnology company developing a first-in-class
molecule for the treatment of cancer and for wound healing. This molecule,
talactoferrin, is an immunomodulatory recombinant protein with a novel
mechanism of action. The Company is developing an oral liquid formulation
of talactoferrin for cancer indications, and a topical gel formulation for
the treatment of diabetic foot ulcers. Agennix has 95 issued patents and 47
pending patents broadly protecting talactoferrin composition of matter,
use, and manufacturing methods.
Agennix Incorporated
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