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Harbor BioSciences – Ship Soon to Leave the Harbor?

Harbor BioSciences is a biotech company focused on the development of a proprietary class of adrenal steroid hormones as novel pharmaceuticals for human health. They have two lead compounds – Apoptone for the treatment of CRPC (castrate-resistant prostate cancer) and Triolex for use in type-2 diabetes, with a possible future indication in multiple autoimmune diseases.  
Harbor has recently presented data from their lead drug candidate, Apoptone (for treatment of castrate-resistant prostate cancer), at two ASCO meetings this year (ASCO Genitourinary Cancers Symposium in March and the ASCO Annual Meeting this June). The data has looked very promising to date, which is why Harbor announced plans to move Apoptone into a Phase 2b trial after presenting initial data from their Phase 1/2a trial in March.). Also, the PCCTC (Prostate Cancer Clinical Trials Consortium) recommended an extension of the Phase 1/2a trial to include patients that have not been treated with taxane chemotherapy.
Now on to the Apoptone data presented at the ASCO Annual Meeting on June 7, the same data that when released to the public caused a drop in the stock price of HRBR to a new 52wk low. Below is an overview of the data released:
Changes in PSA levels were consistent with the properties of this class of agent. In most patients there is an initial increase followed by a decline and/or stabilization of the PSA levels. A decrease in PSA at any time after treatment is seen in 64% of the taxane-resistant evaluable patients with 25% greater than a 30% decline. Antitumor effects were noted in all doses studied including the lowest dose. In some individuals, there have been responses in bone scans ranging from decrease of tracer uptake to resolution of some bone lesions.
Nothing negative was in the results, whatsoever. To further confirm this, the study investigators had many positive comments about the ongoing Phase 1/2a study, and the data so far (see ASCO PR from June 7). Take note, that there are currently no approved treatments for end-stage (hormone and chemotherapy refractory) prostate cancer and the survival time is estimated to be between 8 and 12 months.  If Apoptone succeeds in the upcoming (soon to be initiated) Phase 2b trial, and subsequent Phase 3 trials, it could possibly be the first ever FDA approved treatment for CRPC.
Now, let’s move on to the second drug in the pipeline, Triolex. Harbor has recently reported Phase 2a results on this type-2 diabetes drug candidate. The primary endpoint in the Phase 2a trial was to determine the difference in HbA1c levels (a marker of blood glucose) in Triolex-treated patients when compared to placebo. The summarized results are below:
While there was no significant HbA1c difference in the overall Triolex-treated patients when compared to placebo in either stage of the trial, subpopulations were found in both stages that responded to Triolex. In the second stage of the study, a retrospective analysis identified obese patients in the drug-naïve group (BMI = 31.3) that responded to treatment; a significant time-dependent decrease in HbA1c was observed with a change from baseline of -0.55% at day 84 and -1.1% at day 112 (p=0.041). Triolex reduced HbA1c at least 1.0 % in 5/9 (56 %) compared to 2/13 (15%) in the placebo group at day 112.
As you can see, the primary endpoint of the trial wasn’t met, but there were subpopulations that responded well to Triolex (obese type-2 diabetes patients). The CEO stated that they would review the above data with potential corporate partners to determine the most favorable plan for further development of Triolex in obese type-2 diabetes.
Harbor has said that a study to identify the Triolex target organs in obese, impaired glucose-tolerant assessment of optimal combination effects with marketed products is ongoing. The trial is designed to study Triolex effects on liver glucose output and muscle glucose uptake in response to insulin. Results from this study are expected in Q3 2010. We’re currently in Q3, so we could potentially see the results in the next few weeks/months.
The company only has 29.5M shares outstanding, with around 14% of shares held by insiders, and the potential for huge gains down the road (future Apoptone and Triolex data, possible partner(s) for either drug, or possibly even a buyout target for a big pharmaceutical company). In my opinion, the ship is soon to leave the harbor, and in a year (or maybe just a few months), 30 cents will be looked upon as a bargain. 

Disclosure: Long HRBR