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OXIS International, Inc. (OTCMKTS:OXIS) Could Run On Near Term Catalysts

OXIS International, Inc. (OTCMKTS:OXIS) Could Run On Near Term Catalysts
Written by
Chris Sandburg
Published on
January 23, 2017
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In July last year, we highlighted OXIS International, Inc. (OTCMKTS:OXIS) as being a company keep an eye on. At the time, the company had just signed a deal with the University of Minnesota that would see the two partner up on a new type of cancer therapy called TriKE.We went into quite a lot of detail as to what this revolutionary therapy involved at the time, so we're not going to repeat this detail here – readers looking to catch up can do so by clicking this link. The thrust of the article, however, was that the partnership could produce a number of catalysts over what was then the next 24 months, and that these catalysts have the potential to drive some real upside momentum in Oxis' stock across the period.At the time, markets were pretty underwhelmed by the partnership announcement, and Oxis didn't really move initially. Within a few days, the company had taken a real hit. Now, things are starting to look up. Why? Because we just got one of the catalysts we mentioned might arise as part of the just discussed university partnership.Before getting to the catalyst, let's take a quick look at the drug in question. It is called OXS-1550, and it is currently under investigation as part of a phase 1/2 trial investigating safety and efficacy in lymphoma and leukemia. It is selective to two receptors called CD19 and CD22, which are expressed in abundance by cancer cells associated with the two just mentioned types. Additionally, they are not usually expressed by healthy cells. This means that the drug can seek out cancer cells and bind to them selectively, without binding to healthy cells. There is a third element, and that is that the drug delivers a toxic dose of the diphtheria toxin to the cells to which the drug binds – in this case, the cancer cells that express the CD19 and CD22 receptors. In this way, the drug is selective, and can be administered in far higher doses than traditional chemotherapy, which is limited by its impact on healthy cells and the associated side effects.The latest announcement detailed the addition of two patients to the trial's enrollment roster.Normally, this wouldn’t be too big a deal. Two extra patients in a relatively small trial makes a slight difference, but isn't a game changer. In this instance, it's pretty important, however. Why? Because the two additional patients allow the trial to complete its first phase, and advance into the phase 2 element of the phase 1/2 study.According to the trial's registration page on clinicaltrials.org, once the phase 1 element of the study is complete, the company will enroll 32 further patients as part of the phase 2. With an estimated enrollment of 44 total, the assumption is that current enrollment (including the two patients just added to the trial) is 12 individuals. Six of these will carry forward into the phase 2, and of the 32 new patients, 19 will be lymphoma patients and 19 will be leukemia patients.So what's next? Well, as we have been doing for the past six or more months, we are focusing solely on the clinical updates from this trial as near-term catalysts for Oxis. Primary completion for the trial comes in at June this year, so that gives us around five months to wait for some degree of interim analysis. Before that, we should see some phase II enrollment news. Topline won't come until study completion, which is slated for June 2018.When topline hits, we're looking at the phase 2 primary endpoint as the threshold for success or failure. It is overall disease response at 29 days, with response defined as complete response, partial response and stable disease.As we said last time, cash is our primary concern with this one. With the University of Minnesota conducting the trials, some of the cash risk is mitigated, but before any of this company's assets (including the lead 1550 we have been discussing) move into a pivotal investigation, Oxis is going to have to raise cash. This will be dilutive, and should be taken into consideration before picking up an exposure to the longer-term prospects of the drug.We will be updating our subscribers as soon as we know more. For the latest updates on OXIS, sign up below!Disclosure: We have no position in OXIS and have not been compensated for this article.

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