DARA BioSciences getting more attention Print E-mail
By M.E.Garza   
Tuesday, 12 April 2011 07:17
Shares of DARA BioSciences (Nasdaq: DARA) rose 7.74% and posted a large volume increase after we tipped our premium subscribers on Monday that the company has been doing a number of presentations in front of institutional investors and funds.

New experimental drug can help treat peripheral neuropathy in cancer patients

Good News For DARA's SurgiVision

In addition, DARA' drug icandidate, KRN5500, was reported in an article in NewsMedical to "look promising for alleviating Chemotherapy Induced Peripheral Neuropathy (CIPN) ", based on early phase 2 trial results. The National Cancer Institute and DARA Biosciences will soon be initiating one or more joint studies of the drug in patients with CIPN.

According to Amy P. Abernethy, M.D. an oncologist who has been researching KRN5500, "One of the problems is that our usual pain medicines don't work very well for CIPN. Dr. Abernethy, who is Director of the Duke Cancer Care Research Program at Duke Comprehensive Cancer Center in Durham, NC, explains that oncologists and others who treat cancer patients "take neuropathic pain very seriously." She said that since the current medicines for pain don't work well for patients with CIPN, it takes time to find the right medicine or combination of medicines for each person. Often these individuals are very seriously ill, and they should not have to spend a large proportion of their remaining time in pain, waiting for relief.

Dr. Abernethy finds the preliminary results on KRN550 encouraging, "I think that this drug holds promise as a potential help. It's got a lot of testing to go through, and we'll want to continue to monitor its safety and how efficacious it is, and then also if it's efficacious in a broader range of pain problems."

Investors may not have realized it, but DARA also got good news yesterday when Brainlab AG and SurgiVision, Inc. announced a collaboration aimed at integrating SurgiVision's ClearPoint® product line with Brainlab's iMRI product line, with particular focus on local delivery of drugs and other therapeutic agents to precision targets in the brain under magnetic resonance imaging (MRI) guidance. DARA presently owns over 500,000 shares and warrants of SurgiVision.

Back in February, we interviewed Richard Franco, the Chairman and Chief Executive Officer of DARA BioSciences (Nasdaq: DARA) who told us that his company has two drug candidates with cleared IND (Investigational New Drug) Applications from the FDA and they are deep into clinical study. In addition, the Company has a pipeline of diverse drug candidates, with 82 granted patents and 56 pending applications (U.S. and foreign).  Their leading drug candidate, is KRN5500. (See: http://www.darabio.com/krn5500.htm)

“At the same time we started looking for compounds, we discovered KRN5500, which was a drug that was initially thought of as an oncology drug, as a chemotherapeutic agent,” Franco explained. “The National Cancer Institute (NCI) did three Phase I studies in the United States and there was a fourth study done in Japan supported by Kirin. The drug actually failed as a chemotherapeutic.  But during the trials at Massachusetts General Hospital, they had a patient- who had been a long term patient of theirs- who had Neuropathic Pain for twenty plus years. When put on KRN5500, had complete remission of the pain. The pain never returned and the patient ultimately passed away about a year later from cancer. Given that observation, the people at Mass General, David Borsook, MD in particular, took on to do three different animal models looking at Neuropathic Pain. All were successful. (See: http://www.anesthesia-analgesia.org/content/91/4/955.full)

“At that point in time, when we caught wind of what was going on, it was an excellent opportunity. Kirin had lost interest in the drug from a chemotherapeutic standpoint. We then got Kirin Pharmaceuticals and the capital partners together and cut a deal to have exclusive worldwide rights for pain and for CNS disorders. That’s how we acquired it. As Kirin and the NCI wound down their IND , we filed our IND. We had a pre-IND meeting with the FDA and got our IND approved to study KRN5500 in Neuropathic Pain; primarily in cancer patients initially. We then said, in a company like ours what we’d like to do is really test the drug hard to see if it’s going to give is a very positive signal in regards to safety and efficacy.

 Shares of the company have been consolidating and trading sideways since, but the small float can cause it to move on any positive news flow.

At the time of our interview, Franco told us:  “Big phrama is interested in us. We started the process of putting KRN5500 out there as an out-license candidate. We have a number of companies, right now, doing deep due diligence. We have a virtual due diligence room. There are companies both big and medium sized, both international and domestic that are looking at KRN5500 right now. That is our business model. Once we have proof of concept, is to out-license that to big pharma. The analogy we use, is that we get the ball into the red zone and big pharma then finishes the work and commercializes the product. Their need is great right now. I think when it comes to timing, sometimes you have to be rather lucky than good and I think our timing is very good based on the research we did several years ago."

It may be worth keeping DARA on your watchlist for news or volume increases as some of these institutionals could begin be accumulating.

A look at the company's milestones for 2011:

Date Drug Candidate
Target
Milestone
    3Q11 DB959 Type II Diabetes Phase Ib trial result
    1H11 KRN5500 Chronic Neuropathic Pain in Advanced (Recurrent) Cancer Second Phase II trial initiation

    1H11 DB959 Type II Diabetes Full Phase I trial result



Disclosure: None



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