Low on Cash, Cell Therapeutics Presents More Data (Opaxio Write-up??)
June 3, 2009 at 10:05 am EST | Tags: ASCO, Clinical Trials, Filings & Approvals, Finance
Presented by Biovays…
With cash only left until August, Cell Therapeutics (CTIC) said last night that it’s altering/amending its previously announced “Modified Dutch Auction” tender offer to a fixed price for any and all of the $119M outstanding principal amount (i.e. its whopping debt) of five series of its convertible notes.
Instead, the notes will now be offered in five separate concurrent tiers:
$55,150,000 aggregate outstanding principal amount of 4% Convertible Senior Subordinated Notes due 2010;
$23,000,000 aggregate outstanding principal amount of 5.75% Convertible Senior Notes due 2011;
$7,000,000 aggregate outstanding principal amount of 6.75% Convertible Senior Notes due 2010;
$33,458,000 aggregate outstanding principal amount of 7.5% Convertible Senior Notes due 2011; and
$335,000 aggregate outstanding principal amount of 9.0% Convertible Senior Notes due 2012.
The move comes as CTIC attempts to unload a massive amount of debt as it moves into the summer with potential deal and regulatory milestones, and an empty bank account looming.
CTIC’s stock has been on a roller coaster lately, not unfilled with drama, twists and turns. You can read every post we’ve ever done on CTIC right here.
To add another chapter, CTIC released yet more ASCO data last night. Dr. Howard Safran from The Brown University Oncology Group published early Opaxio (Paclitaxel Poliglumex) Phase 2 data in the ASCO proceedings.
The data was from a single arm study where patients with pathologically confirmed, locally advanced esophageal cancer with no evidence of distant metastasis received weekly Opaxio (50mg/m2) and cisplatin (25mg/m2) for six weeks along with 50.5Gy of radiation.
Here’s the results so far:
N=23 patients enrolled at the time of abstract submission;
5/11 patients with CR s/p resection;
Prophylactic feeding tube “not routinely used;”
Grade 3-4 toxicity in the first 15 patients included dehydration (n=5), loss of appetite (n=5), esophagitis/dysphagia (n=4), nausea (n=2) and weight loss (n=1).
For us, the data is preliminary and does not provide much weight given the lack of a control arm, the lack of feeding tube details and the absence of data on the remainder of the patients. We’d also like to see data from more centers.
CTIC says, however, that they will “explore…with the FDA…a potential U.S. phase III registration strategy for paclitaxel poliglumex in this indication.”
Here was CTIC CMO Jack Singer’s thoughts:
“We are very encouraged by these preliminary phase II results. Patients who have a pathologic CR in most historical studies have had a major survival advantage over those patients with lesser responses. These interesting preliminary findings in an ongoing study indicate that paclitaxel poliglumex may be a uniquely active and selective radiosensitizing therapeutic. Most importantly, patient tolerability appears improved over standard therapy with 5-FU and cisplatin due to the lower incidence of severe gastrointestinal toxicity. It is likely that this is due to the selective accumulation of paclitaxel poliglumex in tumor tissue with continual slow release of the active agent, paclitaxel.”
The press release fueled the stock in early morning trading, sending CTIC shares up $0.19 (11%) to $1.91.
Which makes us wonder, should we do a write-up on Opaxio? Only if we
get 20 or comments on this post!! It’s gotta be by popular demand
guys!! 
Anonymous Tip? Comments? Contact us: hr AT iguanabio DOT com
No positions in CTIC, partners or competitors
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PLEASE – Write -up! Let the facts concerning this drug speak.
Please write an article on this drug. Thank you!
You write it, I’ll read it!
Please do a write up. Go CTIC!!
Wow! This is incredible!
Thanks so much for the amazing support. Let us urge, however, that we don’t own CTIC. We do research solely for doing research. We will gladly provide some insight into Opaxio based off the evidence generated to-date and any/all publicly available information, BUT we can not guarantee that our analysts will give a thumbs up or down.
There are many taxane products out there right now (in development) and this one (i.e. Opaxio) must provide a solid clinical benefit over existing therapies. If we don’t like what we see, then we have to call “Hype.”
Nonetheless, thanks everyone for the comments and patience – lots going on here. We’ll try to get something out within the next several days.
We appreciate your support
Sincerely,
IguanaBio
IguanaBio,
Please do a write-up on Opaxio! It will greatly benefit many people!!
Opaxio has been refined from what used to be Xyotax. It’s a great drug, and it honestly needs alot of marketing so people know what it’s capable of doing.
I look forward to your report
Taxane products are still being made in 2009??? YAWN!!!!!!!!! How old school circa 1995.
One of the major issues that have plagued Cell Therapeutics is the twisting of information that has been disseminated by other Agencies. But to date, IguanaBio has repeatedly put out the facts about the Company and the Cell Therapeutics’s Drugs, and the Drug’s actual potential and capabilities. I would like to see write up on Opaxio from IguanaBio so that the truth and facts can be presented so that investors can make decisions based on the data provided.
I would also like to see another write up on Pixantrone especially about the heart issues. What has never been presented correctly, is the fact that the patients that developed heart issues had already developed these issues with treatments from other drugs (which have many severe side effects, YET, are already approved by the FDA, and in use today! How can so many people, especially professionals in the field of Oncology, miss that FACT?
What is not being brought to light is that these same patients were able to take the Pixantrone and their current heart issues were affected at a much lower level than prior treatments. What I do not see is if the Pixantrone data created new heart related issues. I would appreciate your response. Thank you.
Sincerely,
David
please do so
The Iguana says: June 3, 2009 at 1:53 pm
Wow! This is incredible!
Thanks so much for the amazing support. Let us urge, however, that we don’t own CTIC. We do research solely for doing research.
Yes, this is great. Some info that is not one sided. Just some cold hard facts. Thank you.
I look forward to your report, Thank you,,..
Yes, please write an article on opaxio. I’m looking forward to it.
Can you explore management’s comments regarding their concern on a potential approval for Opaxio in a non-inferiority label in the EU and the limitations on premium pricing associated with such Vs the superiority (survival) label for 1st line ovarainc cancer indication which could come next year. It would seem to me the Company would be shooting itself in the foot to accept a lower price now when survival data is near term which could justify a 2x or 3x pricing premium over the NI application.
I would be interested in hearing about it as I was involved in some of the early CMC work on Xyotax at one of their CROs. I always felt CTIC had a great platform technology and the people were always concerned about doing things in just the right way. I’m dissapointed that the clinical results are not more convincing. Fortunately, my position at one of their vendors precluded me from owning any of their stock.