The pharmaceutical company Merck KGaA (Germany) has this year begun to enroll the first patients for a Phase III clinical trial of Stimuvax®, a therapeutic vaccine for lung cancer. The trial is expected to involve more than 1300 nonsmall-cell lung cancer (NSCLC) patients in 30 countries, including the UK and the USA.
Stimuvax was developed by Biomira Inc. (AB, Canada) under studies funded by Cancer Research UK. It is designed to induce immune responses against cells expressing mucin 1 (MUC)1, a common protein expressed by various cancer cells, including those of lung cancer, breast cancer and colorectal cancer. The immune system then destroys MUC1-expressing cells. A randomized Phase IIb clinical trial run by Biomira, which involved 171 NSCLC patients, has revealed very encouraging results. A median survival of 30.6 months was observed in Stimuvax-treated patients compared with 13.3 months in the control group. Side effects were limited to influenza-like symptoms and mild reactions at the injection sites.
Lung cancer is the most common cancer worldwide and the second most common in the UK after breast cancer. In 2003, more than 37,000 lung cancer cases were diagnosed in the UK, 80% of which were NSCLC. Current lung cancer treatments include surgery and a combination of chemotherapy and radiotherapy.
Therapeutic vaccines are a new alternative to other ‘classic’ cancer treatments, such as chemotherapy and radiotherapy. Vaccines trigger the body’s own immune system to fight cancer cells, hence the side effects can be minimized.
The international Phase III trial – Stimulating Targeted Antigenic Responses To NSCLC (START) – is a randomized, double-blind, placebo-controlled trial that evaluates patients with stage 3, yet stable, NSCLC who have received and responded to at least two cycles of radiotherapy. More information on this trial can be viewed at http://clinicaltrials.gov/show/NCT00409188.
Biomira receives licenses from Cancer Research Technology Ltd (CRT), a development and commercialization company of Cancer Research UK, to develop a number of clinical products. “We are extremely pleased that Stimuvax has entered the final stage of clinical trials. The drug is one of CRT’s portfolios of more than 20 partnered agents in clinical development. Targeted vaccines are an exciting approach that could potentially offer new treatment options for major types of cancer,” said Keith Blundy, chief operating officer of CRT.
Merck KGaA has also planned to test Stimuvax in other types of cancers.
Source: Cancer Research UK (www.cancerresearchuk.org).
Biomira Inc., AB, Canada (www.biomira.com).
Patch-based vaccine against travelers’ diarrhea enters a Phase II clinical trial
LifeTree eClinical (CA, USA) has announced that the company will start a Phase II clinical trial for a novel needle-free, patch-based vaccine against travelers’ diarrhea.
Travelers’ diarrhea is caused mainly by enterotoxigenic Escherichia coli (ETEC) and no vaccine is available. The US CDC estimates that 20–50% of travelers to ETEC-endemic areas contract traveler’s diarrhea and antibiotics are the only treatment, which raises concerns about the spread of antibiotic resistance.
The new vaccine patch contains ETEC’s heat-labile toxin as the antigen, which travels through the Langerhans’ cells of the skin to the underneath lymphoid tissue, inducing immune responses. The patch-based technology is a proprietary of Iomai Corp. (MD, USA) and has also been applied in transcutaneous, needle-free influenza vaccines.
“Iomai is excited to work with LifeTree on the trial. This effort will provide crucial information about the vaccine and the disease as we prepare to enter late-stage trials,” said Stanley Erck, president and chief executive officer of Iomai. “The vaccine could fill a significant need: as many as 50% of travelers to areas where ETEC is endemic are sickened, yet no vaccine is available in the USA.”
LifeTree eClinical provides clinical technologies and services for Phase I–IV trials, ranging from patient registries to disease diagnoses and epidemiological analyses. It has an extensive database system and also provides useful trial management tools.
“We are pleased to be managing a clinical trial that may help prevent one of the common side effects of traveling,” said Patrick Schmidt, president and chief executive officer of LifeTree. “In today’s global economy, the frequency of international travel increases exposure to bacteria, so this study could ultimately provide an important addition to the healthcare safety precautions we should all be practicing”.
The safety of the patch-based vaccine and the frequency of ETEC infection in volunteers traveling to ETEC-endemic areas will be assessed in this Phase II, placebo-controlled trial. The results will hopefully provide vital information for a future Phase III clinical trial.
Source: LifeTree eClinical, CA, USA (www.lifetreeclinical.com).
Iomai Corp., MD, USA (www.iomai.com).