OK, back to some fun. A half-year. Six-months. 184 days. More grey hairs. This has been a fun experiment. Once a week (or so), I jot down a random thought and post it here. It has served as an online journal and a cheat sheet of sorts; sometimes with data, mostly without, to remind me of ideas that sounded interesting at the time.

I don’t get many reads, referrals or links, but that wasn’t the point. My goal wanted to keep an eye on the sector as life continues to plow forward. Today, I wanted to go back and review my thoughts – update the stories, and evaluate what I liked and didn’t like. So, before the short week expires and we hit the Thanksgiving festivities – a quick recap since May. If you want to look at the referenced post, just click on the link.

My very first musing was on AVEO ($AVEO), but having written something more about it in June, I’ll wait a bit longer before reviewing my comments.

The honor for the first update goes to Icagen ($ICGN), which had a remarkable change in fortune. Prior to data release, they were acquired by $PFE for $6/share, or $56 MM;  when I wrote about the company in May, they were trading at $2.72/share! Not bad for Phase I data. Their strategy made a lot of sense to me – selecting targets with known human genetic models. I hope to find another one like this.

I then decided to take a look at the stem cell place, in particular neural stem cells since I have a neuroscience background (yup, hard to believe isn’t it!)

StemCells ($STEM) initiated their Phase I/II trial in patients with chronic spinal cord injury in September, so we have hope, optimism, and a long way to data. They have traded down to the $2/share point.

NeuralStem ($CUR) is making steady progress with their Phase I ALS program and was granted permission to dose the final six patients in the cervical region of the spinal cord just a couple of weeks ago. The first 12 patients have been dosed in the lumbar region – so far, so good. No SAEs in these patients, as of data presentation at the American Neurological Association Meeting in September.

The London-listed ReNeuron ($RENE) is also chugging along, having been allowed to advance dose their 2nd cohort for disabled stroke patients. More to come on their interim results on the 28th.

* 1:10 Reverse split announced 7/1/11

So far, delivery of neural stem cells at the doses tested appear safe; unfortunately it is unclear what expectations are for efficacy. Taking a step back, we have recently discovered that the human embryonic stem cell (hESC) space was not as stable, with Geron ($GERN) pulling out to focus on oncology and at the same time shutting down their Phase I oligodendrocyte program in spinal cord injuries. More here.

On the next post, I highlighted three transitional stories from Oxigene ($OXGN), RXI ($RXII), and Allos ($ALTH). $OXGN announced restructuring plans in September to focus on earlier stage programs – we’ll have to wait to see what pans out. $ALTH had a merger opportunity with AMAG ($AMAG), but fell apart when AMAG shareholders voted management’s decision down and resulted in the CEO, Brian Perrera, departing – the company is now looking at strategic alternatives (code for sale to the highest bidder). There was a rumor that Spectrum ($SPPI) would be interested in $ALTH – keep an eye out, at the right price everything looks good. Why could it make sense? Simple. $ALTH markets Fotolyn (pralatexate) for relapsed/refractory peripheral T-cell lymphoma patients. $SPPI is a small oncology company already detailing Fusilev (levo-leucovorin) to medical oncologists, so why not put something else in their bag that they can sell? Granted, they would likely need to target a slightly different physician population in hematology-oncology, but not too far off. We’ll skip $RXII for now (see October’s RNAi post)

The next two posts introduced three small oncology firms, CytRx ($CYTR), Threshold ($THLD) and ZioPharm ($ZIOP).

With  $CYTR, I did not write anything useful about their current oncology pipeline, but they are developing INNO-206 for soft-tissue sarcoma, a cancer both $THLD and $ZIOP are also looking to treat. Hopefully, nobody invested in May or June – they diluted existing shareholders to raise $20.4 MM gross in July, and are now trading $0.38/share with a market cap of $55 MM, roughly 38% lower from May. I had planned on taking a closer look back then, but never got around to the process – at this valuation, I should tackle this soon.

The value of $THLD has not changed significantly over the past six months ($1.81/share on 5/20/11 when I posted vs $1.60/share on 11/18/11, a 12% loss) and we still expect controlled Phase II data in pancreatic cancer next month. This is the value driver for TH-302. If TH-302 fails in pancreatic cancer, then our next inflection point will be one year later (late 2012) when interim Phase III data in advanced soft tissue sarcoma is reached. What I don’t yet know, is how the probability of success will change in this indication if TH-302 fails or works in pancreatic. They are different types of cancers with different origins, growth rates and phenotypes. For example, can TH-302 be activated in a small, but fast growing tumor? How about a slow, but big tumor? At least, they are using overall survival as their primary endpoint.

On the other hand, $ZIOP share price has dropped roughly 31%, from $6.59/share when I looked at it, to $4.49/share, as of Friday’s close. Quickly scanning through their press releases, nothing strikes as being overly negative. Perhaps, others thought that $ZIOP was overvalued as well? I still have concerns with PFS as palifosfamide’s primary endpoint in advanced soft tissue sarcoma, and I am still working out how ZIN ATI-001 and/or ZIN CTI-001 (Adenovirus and cell-based regulated expression of IL-12) will fare. In recent years, we have had several gene therapy-based oncology failures from Introgen’s p53 expressing adenovirus to Genvec’s ($GNVC) TNF-alpha expressing adenovirus; going further back, $ONXX gave replication-conditional adenovirus a shot before betting on sorafenib. Different strategies, different tumor types, but all have ended in failure. $ZIOP has enough programs with multiple shots on goal, so it might be time to take a closer look at their financials, timelines, existing clinical data.

Looks like this has been my longest post to date. If you made it this far, thanks for stopping by. It has been fun and I have lots of thoughts to work on, so enjoy the short week, and hope to see you again. Feel free to comment and provide suggestions.