Cell Therapeutics: Worth Buying Ahead of FDA Decision

Cell Therapeutics (CTIC) is worth buying, in my opinion. There are only seven trading days until CTIC investors may get some very exciting news.

On February 10, 2010 the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). NHL is the fifth most common cancer in the United States.

"The upcoming ODAC meeting is a very important milestone in the NDA review process and we look forward to discussing the efficacy and safety data for pixantrone with the members of the panel and the FDA review team," stated James A. Bianco, M.D., CEO of CTI. "As there are no other drugs currently approved in this setting, we believe that pixantrone would fulfill a significant unmet medical need for patients with relapsed/refractory aggressive NHL."

At the ODAC meeting, committee members evaluate presentations of efficacy and safety data made by the pharmaceutical sponsor of the drug under review, FDA review staff, and occasionally third-party oncology experts in an open forum. Following the presentation, the committee members discuss questions posed by the Agency review staff and the meeting concludes with the committee voting on a recommendation to the FDA regarding approval.

Pixantrone is a fast track designated product which has been accepted for review by the U.S. Food & Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010. Results of the PIX301 phase III trial presented demonstrated improvement across primary and secondary endpoints of the study at a minimum of nine-month follow-up from end of treatment.

Pixantrone showed benefits over other chemotherapy agents as follows:

• A greater overall response (ORR), including a greater overall cure rate (CR).
• A more durable response a response (> 4months).
• Overall survival with a 48% increase in median overall survival for the pixantrone arm (10.2 months) versus the comparator arm (6.9 months).

Results presented also included a patient subgroup analysis demonstrating that complete response (CR), partial response (PR) and PFS were robust irrespective of risk factors or prior therapy. Pixantrone also provided superior disease control rates over comparator arm with 22 of comparator recipients progressing within the first evaluation point versus 14 for pixantrone recipients.

Zacks believes positive data from the follow up study should weigh in the company’s favor when the FDA meets to decide on the drug’s approval.

I expect CTIC stock could very well rally 25% or more ahead of the February 10th review, and beyond the 52 week high of $2.23 if Pixantrone is approved. CTIC short sellers will likely be squeezed.

Disclosure: Author holds a long position in CTIC

Comments

[[e-mail]]

For your best interest, i think you'd be wise to consider doing the opposite, sell your shares before the panel meeting. It's going to be ugly.

Feb 03 09:25 AM

[dilla]

why would you be short a stock @ 1.00 when a favorable panel meeting could make it trade @ 8.00

Feb 03 11:01 AM

[Adult]

The data they presented to FDA involved only 140 patients !
Why people still believe they will have postive result ?

100% sure FDA will say : "Go back and return with more data"

Exactly as DNDN on 07 when their share price clashed after
FDA gave above comment,and the data of DNDN at that time was even better than the CTIC just presented.

Feb 03 04:58 PM

[hashepsut1988]

you don't seem to understand statistical analysis in general nor the specifics as to why CTIC stopped with 140. I comment just on the former point: finding a stat. significant effect with LESS samples actually indicates a LARGER clinical effect (since the test has less power)---like catching a fish with a net with a wide mesh compared t doing so with a very fine mesh.

Feb 08 12:11 AM

[SouthernBeachGuy1960]

No telling what the FDA will do, but when there is nothing else available and there were good clinical trials, why not give it a try. Without it, surely people will die. With it, they may provide their families with more time. The only looser will be the Insurance companies that will have to provide more care......... I personally go for giving the patient more time. Hope the FDA does.

Feb 03 05:19 PM

[robert@fastec]

Please note the las SEC feeling published on feb. the 5.
They (CTIC) want to increase shares from 800.000.000 to 1.200.000.000 making them much more dilute.

Feb 06 03:51 AM

[novicemom]

The additional shares may or may not be used even if approved. Bianco is smart to put a safeguard in place to raise more operating capital in the event that the worst happens....which imho, is doubtful. No shareholder wants to see further dilution but if you have sincerely done DD and understand the specifics of the Pix data as well as the depth of the additional pipeline, you understand why the additional shares, albeit frustrating, make sense!

Mar 07 09:54 AM

[JICJIC]

People keep bringing up the 140 Patients but CTI cleared that number with the FDA in the SPA when they could not enroll the originally agreed to number. Moreover, since Pixantrone was fast tracked that means that the FDA works hand in hand with the Company offering input along the way. If the study size were in question they never would have gotten to this point...there would be no ODAC Meeting. The FDA may ask for another trial but they could just as easily grant approval and at the same time request further studies if they feel compelled to for some reason. This drug fulfills an unmet medical need as agreed to by the FDA when fast tracking it in the first place. Sending CTI back to the drawing board when the drug clearly shows efficacious results would be a considerable blow to patients with no where else to turn.

Feb 07 09:33 AM

[dlupy]

what do you guys think about today sell off? is this jst a knee jerk or should one sell and cut their losses?

Feb 08 11:39 AM

[dlupy]

what is going on today? is this just a knee jerk reaction to a bad report or is it time to get out of this stock?

Feb 08 11:44 AM

[mgcolin]

This one is a real tough call. I would bet they have a heated debate and make CTIC go back for some more data. Just too many holes and question marks. Reducing the trial size is a concern, although the resaon they gave, difficulty in recruiting patients, does hold some water since these are pretty desperate patients and oncologists genuinely like to try out combinations in those circumstances. The side effects are obviously a big deal, but again in this desperate population side effects shouldn't be as major a concern as having another weapon in the arsenal.

With this one my bet is they don't approve, demand more data as they did with DNDN.

Feb 08 05:09 PM

[Michael Kudrna]

Should they be approved for patients with little hope like the study was geared towards? Yes

Will they get approved for those patients? Looking more like probably not...which is why I have little trust in a governing body making the right choice as I've said in my blog.

I sold for a small loss and am putting some of it in GOIG instead...much rather put money towards a winning stock than a stock with so much hatred for it. Now that the review is postponed due to weather (unknown makeup date last I saw), we have the earnings report on Thursday and I don't have a lot of confidence in how all of that will be perceived. I'd wait until after Thursday and after a response from CTIC to the questions posed by the FDA before I even considered putting money back to work here. Could be a big winner, especially with the short interest, but the risk is high and the momentum is to the downside...I'd rather bow out and put my money to work elsewhere. Good luck out there.

Feb 08 09:13 PM