OneMedPlace introduces a new series, “The Briefing Room”, capturing the past week’s most important developments in microcap life sciences indexes. We’ve combed the net searching for the most interesting tidbits of information, tracking strategic partnerships, mergers and acquisition activity and clinical milestones of promising public emerging growth companies. Stay tuned for this weekly column of news briefs capturing the essential events that have slipped through the cracks. In the coming days, OneMedPlace will roll out similar weekly columns identifying important dates and market influencers on the horizon for your investment portfolio.
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Star Scientific, Inc (NASDAQ: STSI), announced last week the enrollment of a first patient in an Alzheimer’s study of the company’s dietary supplement Anatabloc. The company will produce the study through its wholly owned subsidiary, Rock Creek Pharmaceuticals, Inc.
Anatabloc is approved in the United States as a dietary supplement to support a natural anti-inflammation process in the body. In July the company announced plans for the production and sale of Anatabloc face cream to improve appearance of the skin.
The anatabine citrate used in Anatabloc, an alkaloid found in Solanaceous plants, has been shown to be effective in lowering amyloid levels and other markers of inflammation, according to the company press release.
The commencement of the study comes during a busy summer for the Virginia-based pharmaceutical company. In June and July Star Scientific received multiple patent claims related to the syntheses of anatabine, and in August announced the change of the NASDAQ trading symbol, from CIGX to STSI. The company also sells CiGRX, a smoking alternative dietary supplement to reduce the urge to smoke.
In early August, Star Scientific reported net sales totaling $1.6 million for the three months ending June 30, 2012. The company reported a 560% increase in net sales for the six months ending June 30, 2012 compared to year-to-year figures, largely based on increased sales of Anatabloc.
Read the full announcement here.
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Last week, Kips Bay Medical, Inc (NASDAQ: KIPS) announced the commencement of a U.S. feasibility trial in Bern, Switzerland, with first implants and enrollments anticipated to begin the first week of September. The objective of the study will be the demonstration of initial safety and performance of the company’s eSVS Mesh, a technology designed to maintain patency of autologous saphenous vein grafts in patients undergoing coronary artery bypass graft surgery.
The eSVS Mesh is a flexible extravascular knitted nitinol prosthesis that reduces vessel wall stress, and mitigates potential for focal intimal hyperplasia and clot formation. The focus of this trial is to demonstrate safety and performance sufficient to allow the FDA to approve an IDE for a pivotal study. In July, the company filed an application for an IDE to include four US sites in this feasibility trial. Kips Bay Medical has been pursuing a feasibility trial at eight well known cardiac centers throughout Germany, Switzerland, Italy and France.
Kips Bay Medical was founded in 2007, and is headquartered in Minneapolis. In late August, the company’s share price has approached its 2012 peak of $1.72 set in early April. The stock currently trades at double its 52-week low of $0.79, set in mid-July. In August, the company reported $6.9 million in cash in its 2Q2012 earnings report.
Read the full announcement here.
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Last week, XOMA Ltd (NASDAQ: XOMA) announced the company’s lead candidate, gevokizumab, had been granted Orphan Drug Designation from the FDA for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis.
Gevokizumab is the company’s IL-1 beta modulating antibody, a potent monoclonal antibody that can have applications in treatment of Behcet’s and other forms of non-infectious uveitis, cardiovascular disease, and other auto-inflammatory diseases. Uveitis is an inflammatory disease that affects the uvea, which can lead to decreased vision, pain, sensitivity to light, and floaters.
Last week, the Berkeley, CA-based biotech also announced the filing of a shelf offering that would allow for the sale of $100 million worth of common stock, preferred stock, debt securities, and warrants.
In the United States alone, approximately 350,000 people suffer from uveitis; of this patient population, approximately 130,000 are afflicted with more severe forms. Oral corticosteroid is the only systemic therapy approved by FDA for severe forms of uveitis. This treatment is burdened with multiple side effects, including osteoporosis, hypertension, hyperglycemia, hypercholesterolemia, and impaired wound healing. In the eye, this treatment can cause cataract formation and glaucoma.
To establish market opportunity, insiders look to the rapid inflation of the rheumatoid arthritis market as precedent. Both conditions carry similar traits, advance in similar ways, and affect a similar patient pool. In 20 years, the RA market has grown from $100M in 1990 to more than $10 billion today – which can be directly attributed to the introduction of new treatments.
Read the full announcement here.
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Stellar Pharmaceuticals Inc [OTC BB: SLXCF] announced last week a partnership granting the company exclusive Canadian promotional rights for Gelfoam from Pfizer Canada.
Gelfoam is a medical device approved in Canada and the United States for use in surgical procedures as a haemostatic agent. Stellar markets Bezalip SR, Soriatane, NeoVisc, and Uracyst in the Canadian market, in addition to two other commercialized products abroad.
In June, the company announced that it had acquired the Canadian rights from Theramed Corporation for Collatamp G, a lyophilized collagen implant approved in over 50 countries for the local hemostasis of capillary, parenchymatous and seeping hemorrhages in areas with a high risk of infection.
Read the full announcement here.