Somethings in the works..,
Next week’s COMP meeting:
4.2. Orphan designated products for discussion prior to adoption of CHMP opinion
4.2.3. - amikacin –EMA/OD/024/06, EU/3/06/387, EMEA/H/C/003936
a) Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis (EMA/OD/024/06, EU/3/06/387)
b) Treatment of nontuberculous mycobacterial lung disease (EMA/OD/191/13, EU/3/14/1259)
Action: For discussion
Draft report on review of OMPD
If they weren’t in line for a Conditional Approval - - if the CHMP was going to reject them outright, why would this be on the COMP Agenda?
Also why the reference to CF?
Sentiment: Strong Buy
The EMEA was not prepared to recommend approval, since there was not enough evidence that Arikayce can 'permanently' clear the bactueria from the sputum (what drug can even convert?), and thus the “benefits of Arikayce did not outewiegh its risks” (what risks?)
So 30% safe,culture conversion on drug within 6 months and 80% of those still converted and safe after 1 year of non use while no drug has been approved for a lethal disease is not good enough for a The EMA? Just BIZARRE
Yes Jess, I see pre AUTHORIZATION noted, but the EMA has already allowed the use in 3 countries in a compassionate use authorization and didn't Mr. Lewis purchase over 1/2 million dollars worth of stock just a few short months ago at $13+. We are golden.
Sentiment: Strong Buy
Good points pianoman. Credit to Hound-dog..,
At clinical trials.gov, a study conducted by University of Miami and University of Florida:
“To determine the prevalence of nontuberculous mycobacterial infection (NTM) in pediatric patients with cystic fibrosis in the State of Florida. HYPOTHESIS: There is high prevalence of NTM in CF pediatric population in the State of Florida, and likely higher than in the rest of the country.”
University of Miami
University of Florida
Information provided by (Responsible Party):
Andrew Colin, University of Miami
Study completed; results not yet posted.
New patent application filed last week.
Platinum for cancer treatment, encased in liposomes, and injected into the body cavity to bypass the gastric tract.
One aspect of the invention relates to methods of treating cancer in a patient comprising administering intraperitoneally to a patient in need thereof a cancer treating effective amount of a composition comprising a lipid-complexed platinum compound wherein the concentration of the platinum compound of the lipid-complexed platinum compound composition is greater than about 1.2 mg/ml. Another aspect of the invention relates to lipid-complexed platinum compound compositions where the concentration of the platinum compound is greater than about 1.2 mg/ml.
Insmed previously granted Eleison a license to develop liposomal cisplatin for inhalation:
Inhaled Lipid-complexed Cisplatin (ILC)
Eleison has an exclusive worldwide license to ILC, a novel, sustained release formulation of cisplatin in a nanoscale lipid based complex administered via inhalation, in development for pediatric osteosarcoma (OS) - bone cancer. ILC was designed to deliver high levels of sustained release cisplatin targeted to the lung, without systemic-related toxicities. ILC has been evaluated in 89 patients in four clinical studies, with evidence of efficacy in several cancer types including lung and bronchoalveolar.
In pediatric OS, approximately 35% of patients fail first-line therapy, mostly with metastatic recurrence only in the lungs, and with poor prognosis (five year survival of such patients is
The Eleison license doesn’t pertain to liposomal cisplatin for injection into the body cavity, targeting cancers beyond the lung; hence the new patent application.