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Ventavis Scrutinized for IPF-Related Pulmonary Hypertension
by John C. Martin
07-07-05 - A medication already approved as a therapy for people with pulmonary hypertension (PH) is about to enter a second round of clinical testing to determine if it's safe for those with PH related to another lung disease known as idiopathic pulmonary fibrosis, or IPF.
Expanded Role Possible
CoTherix, the maker of Ventavis (iloprost) Inhalation Solution, announced in early June that it has initiated a Phase 2 clinical trial to test the drug in a group of patients with the two illnesses. "Ventavis is an ideal candidate to investigate for IPF patients with pulmonary hypertension," said James Pennington, MD, Executive Vice-President and Chief Medical Officer of CoTherix. "Since Ventavis is inhaled, we believe it targets only the non-fibrotic portions of the diseased lung, increasing [blood vessel dilation] only in the ventilated areas, and reducing the potential for mismatched ventilation and pulmonary bloodflow, which can lead to heart strain and fainting."
The primary objective of the double-blind, placebo-controlled clinical trial, called ACTIVE, will be to determine the safety of Ventavis in patients with PH who also have been diagnosed with mild to moderate idiopathic pulmonary fibrosis. Included in the study will be the standard 6-minute walk test, which determines how far a particular patient can walk in a given time period; and any changes in disease progression or blood circulation.
The study will involve about 50 patients at 15 sites in the United States, CoTherix stated.
Progressive Scarring Disease
Idiopathic pulmonary fibrosis is a disease characterized by progressive scarring of the lungs that gradually complicates breathing. When it reaches that point, the disease prevents organs from obtaining levels of oxygen that keep them functioning. IPF is one of 200 diseases that fall into a class known as interstitial lung disease (ILD), in which lung scarring is a key manifestation.
While IPF can be linked in some cases to certain causes like exposure to inorganic or organic dusts, chemotherapy or radiation therapy, lung infection, or certain connective tissue diseases, in most cases, it has no known cause.
It's estimated that approximately 83,000 people in the United States have IPF, and an estimated 31,000 new cases develop each year. The disease typically strikes between the ages of 50 and 70, and tends to affect men more than women. The key symptoms are shortness of breath and a dry cough.1 According to CoTherix, the average odds of survival for patients with the disease is approximately 4 to 6 years after diagnosis.
Pulmonary hypertension, in which the blood pressure in the pulmonary artery leading from the heart to the lungs rises to abnormal levels, can be a serious complication of IPF.2 It's estimated that about one-fifth of IPF patients also have been diagnosed with pulmonary hypertension.
'Limited' Therapy Choices
"Treatment options for these patients are extremely limited," said Richard Channick, MD, an associate professor of Medicine at the University of California, San Diego, an expert on pulmonary hypertension and its treatment who will be taking part in the upcoming clinical trial. "There is a significant need for new therapies to treat the pulmonary hypertension complications of this progressive disease. I am very excited about the potential for Ventavis in IPF, and look forward to participating in the study."
If approved, Ventavis would become the first available medication to treat PH associated with IPF. It was initially approved as a PH medication late last year.
1. Coalition for Pulmonary Fibrosis. What is IPF? Some Basic Facts. Available at: http://www.coalitionforpf.org/Patients/whatisipf.asp. Accessed July 7, 2005.
2. Olschewski H, Ghofrani HA, Walmrath D et al. Inhaled prostacyclin and iloprost in severe pulmonary hypertension secondary to lung fibrosis. Am J Respir Crit Care Med 1999 Aug;160(2):600-7.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
Judge owes an explanation
We expect our judges - even semiretired ones - to avoid even the appearance of impropriety, and former Boone Circuit Judge Jay Bamberger fails to meet that expectation in a controversy over his getting paid as a director of a nonprofit group he helped create while he was still behind the bench.
Bamberger's participation is a side issue in a lawsuit that challenges the group's existence and funding, but it's a troubling side issue. Bamberger must think so too - after questions about his role were raised in the lawsuit, he returned more than $50,000 he had been paid over the last year and resigned from the board of the Kentucky Fund for Healthy Living.
The fund was created with money left over from a $200 million settlement of a case arising from the diet drug fen-phen. As the judge who oversaw the case brought by users against the drug's manufacturer, Bamberger approved the settlement and specifically the creation of the fund. He also ordered - and this is especially troubling - that the documents related to that approval be sealed.
A Lexington attorney representing some 200 of the 431 original plaintiffs has sued four attorneys involved in the original lawsuit - including Stan Chesley of Cincinnati - saying the $20 million set aside for the fund should have been distributed to the plaintiffs. The other three attorneys are also directors of the fund and (like Bamberger was) are paid $5,000 a month plus expenses. Northern Kentucky jury consultant Mark Modlin, a friend of Bamberger's, was hired as the non-profit group's president and runs its day-to-day affairs. Bamberger became a director in June 2004, about six months after he retired as judge and signed an order relinquishing the court's control of the settlement.
In 2004, the fund awarded $250,000 in grants for various health-related programs statewide and paid nearly $400,000 in fees to directors and investment managers.
An attorney for the fund said he investigated Bamberger's participation and found no conflict of interest, but frankly we're flabbergasted.
It's not unusual for a fund to come out of a medical class-action suit like this. But it's certainly unusual for a sitting judge to oversee such a fund's creation, then get himself appointed to a $60,000-plus a year part-time position to help run it.
With 22 years on the bench, Bamberger has a reputation to uphold, as well as the reputation of all judges past and present. We think he owes the public an explanation for his actions.
For now he's declining to talk about the case, citing a gag order issued by William Wehr, the semiretired judge appointed by the Kentucky Supreme Court to oversee the overall lawsuit. We think Bamberger - who is not a defendant in the lawsuit - should petition Wehr for permission to speak. The public would like to hear what he has to say.
http://news.cincypost.com/apps/pbcs.dll/article?AID=/20050809/EDIT/508090327/1003
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