For a reason or another, the market is extending its bad mood attitude towards almost all industrial firms, including, the extremely well to do or those that announced extremely good news regarding their growth potential. Usually long-term investors do not have to be careful especially when their choices are made following a thorough dew diligence, but traders will surely be careful and will sell, then buy and sell then buy when the market’s mood reverses and they know how to play their game. We will not fall victim of fear and throw from hand excellent stocks, but we will accumulate on weaknesses depending on our budgets.
In such circumstances, we usually post news from firms that have drugs that might offer unmet needs for patients who have no hope for treatments with conventional marketed drugs. From today’s news we chose the following:
Ideopathic Pulmonary Fibrosis (IPF)
Intermune Provides Compassionate Use of its Investigational Drug Pirfenidone
Intermune (ITMN) is providing the compassionate Use of Pirfenidone through a multi-center Expanded Access Program (EAP) in the United States to be conducted under InterMune's U.S. IND. The compassionate use is for patients with idiopathic pulmonary fibrosis (IPF), which is an irreversible and ultimately fatal disease.
In IPF there is a progressive loss of lung function due to fibrosis (scarring) in the lungs, which hinders the ability of lungs to absorb oxygen. IPF causes shortness of breath, and a deterioration in lung function and exercise tolerance. IPF patients follow different and unpredictable clinical courses and it is not possible to predict if a patient will progress slowly or rapidly, or when the rate of decline may change. Periods of transient clinical stability in IPF, when they occur, inevitably give way to continued disease progression.
The median survival time from diagnosis: 2 to 5 years, with a five-year survival rate of approximately 20-40 percent, which makes IPF more rapidly lethal than many malignancies, including breast, ovarian and colorectal cancers. IPF typically occurs in patients over age 45, and tends to affect slightly more men than women.
Pirfenidone is an investigational therapy in late phase trial in the U.S. and has not been approved by the U.S. Food and Drug Administration (FDA).
Expanded access programs provide a mechanism for early access to an investigational drug in the pre-approval period to treat patients with a serious or immediately life-threatening disease or condition that has no comparable or satisfactory alternative treatment options.
Jonathan Leff, M.D., Executive Vice President of Research and Development, InterMune said, "This EAP provides a mechanism for eligible patients to access pirfenidone as a treatment option, following the recent successful completion of our ASCEND Phase 3 trial and prior to FDA's final decision on the approvability of pirfenidone in the United States."
Criteria For Enrollment
To enroll in the EAP, a patient must meet specific clinical criteria. Eligible patients must have a clinical and radiographic diagnosis of IPF with the presence of a usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT). Additional criteria for the EAP are listed on www.clinicaltrials.gov.
Only a physician who is participating in the EAP can assess a potential patient for eligibility.
The EAP protocol contains provisions for stopping enrollment of patients in the EAP upon a decision by the FDA on the approvability of a pirfenidone New Drug Application (NDA).
There are currently a limited number of sites accepting patients for enrollment to the pirfenidone EAP and InterMune expects that all sites will be participating by September of 2014. InterMune is working with the Pulmonary Fibrosis Foundation (PFF), the Coalition for Pulmonary Fibrosis (CPF) and other advocacy groups to enable patients with IPF to obtain information about the pirfenidone EAP.
For more information:
Contact InterMune Medical Information at 888-486-6411 or the Pulmonary Fibrosis Foundation (PFF) at 844-TalkPFF (844-825-5733) or visit www.clinicaltrials.gov.
Pirfenidone is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. Pirfenidone also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.
This is a typical example of biotech companies’ attempts to treat untreatable diseases. Fibrosis, regardless of where it exists and based on its causes and the organ it affects has been an untreatable condition that could progress into life-threatening disease. Liver cirrhosis is fibrosis of the liver that could result from liver inflammation caused by viral infection, especially hepatitis C virus (HCV) and others.
Other firms are also developing drugs that can reverse fibrosis or halt its progression, saving organs, like the liver, for example, from deteriorating and the patients from the need of transplant if organ transplantation is feasible.
We will tackle the subject of fibrosis and the firms developing treatments in a future posting.
The biotech evolution is at its best regardless of the market’s mood.
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