A biologics startup developing a way to help patients with bladder cancer by using their own cells to regenerate tissue and to reconstruct a urinary tract has expanded a Phase 1 trial to five sites and has performed the procedure on its seventh patient. But despite getting a $15 million private placement last fall, Tengion is facing an uncertain future if it cannot secure more investment before May.
It is continuing to recruit three more patients for the trial to assess the safety and preliminary efficacy of the neo-urinary conduit. It has demonstrated that urinary tissue can be regenerated in a limited number of patientsand expects to follow it up with a Phase 2/3 trial later this year. Because more sites will be set up, the company believes it will better positioned to recruit a broader patient population than before, according to a conference call it held yesterday.
The current level of care for bladder cancer patients who need their bladder removed involves using bowel tissue to create a which critics argue puts patients at risk for complication from the use of this tissue. because it involves a longer surgery and post-op recovery time. There are more than 20,000 urinary diversions performed annually in the United States and Europe, according to its website.
A program to regenerate kidney tissue for patients suffering from advanced chronic kidney disease is also progressing. The procedure is intended to prevent or delay the need for dialysis or a kidney transplant by regenerating functional kidney tissue, according to the website. If the Medical Products Agency in Europe accepts its clinical trial application, it expects to start a Phase 1 clinical trial in Sweden next quarter. It is also submitting an IND to the FDA for its neo-kidney augment procedure next quarter. It expects to start a Phase 1 clinical trial in the U.S. in the fourth quarter of the year with initial proof-of-concept data expected next year.
More than $27 billion in Medicare costs each year are from to patients with end stage renal disease, associated with a 20 percent annual mortality rate, according to the United States Renal Data System.
The regenerative medicine technology that’s the basis for Tengion’s work was originally developed at Wake Forest University’s Institute for Regenerative Medicine. Tengion was spun out of the university in 2004.
In its fourth quarter financial results yesterday, the company stated that, based on its currently expected level of operating expenses and debt repayments, it only expects to be able to fund its operations to May 2013. But under the terms of the financing agreement from last October, the company may seek an additional $10 million in financing without the need to obtain any additional consent.
The concept of regenerating tissue and organs is an exciting one, particularly for people with chronic kidney disease. Adam Feinberg of Carnegie-Mellon University is developing a heart-tissue regeneration process using artificially produced protein framework and genetically engineered cells to help patients with heart failure. Researchers at the Royal College of Surgeons in Ireland have developed a way to regenerate bone using gene therapy.