Things are really beginning to heat up at Accentia Biopharmaceuticals (OTC:ABPI) these days. Monday, the Tampa Florida company announced their completion of enrollment of their ongoing FDA fast-tracked Phase-3 trial for their lead compound, Sinunase, for the treatment of Chronic Rhino Sinusitis. The 300th patient has been enrolled. According to the company there is not one FDA approved treatment for CRS though it is estimated to have a larger market then Asthma with an estimated 37 million CRS sufferes in the United States alone.
The company stated:
Based on an interim blinded intent-to-treat analysis of the primary endpoint of complete resolution of the cardinal symptoms for the first approximately 147 patients to finish the trial, the Company believes that the trial at its conclusion will show a highly statistically significant outcome for SinuNase. There continues to be a strong positive correlation of symptom resolution and objective evidence of improvement by endoscopy and CT scan. The placebo control arm in the SinuNase study is essentially buffered water with a yellow dye, which has shown no antifungal activity in quantitative microbiologic tests. If no patients in the placebo control arm are achieving the primary endpoint of complete resolution of the cardinal symptoms, then the interim blinded results would infer that about 40% of SinuNase patients are reaching the primary endpoint, whereas only a 9% response rate would be needed to reach the required statistical threshold. Pursuant to Regulation Full Disclosure (Reg FD) the company will file on Oct 9, 2007 an 8-K containing its current investor presentation on SinuNase. This presentation will be used in investor meetings and in discussions with potential commercial partners. This presentation is also available at the Company's website (www.accentia.net). The Company, nevertheless, cautions that these are blinded results and that, as in any double-blinded placebo controlled clinical trial, the statistical analysis of the unblinded data at the conclusion of the trial could be adversely influenced if there is a greater than anticipated placebo effect in the control arm of the study.
Look for results to be announced in 18 weeks.
If Accentia can sucessfully bring Sinunase to the market with potential multi-billion dollar revenue potential I believe you could see a dramatic rise in the price per share.
In addition to the Sinunase update the company also announce that it met withthe FDA on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting for their compound Revimmune. The FDA confirmed it's support for Accentia to submit an IND for a pivotal Phase 3 randomized controlled, multi center clinical trial of Revimmune. Which is Accentia's potential theraputic for refractory, relapsing remitting Multiple Sclerosis.
The company stated:
The Revimmune MS study will enroll subjects in a one-year study comparing baseline disability to disability at month 12 with an interim data analysis. After consultation with the FDA on the design of the trial, it was agreed that the primary endpoint will be recovery of lost function and that this unique study will be done under a special protocol assessment (SPA). Accentia will proceed diligently with submission of the IND under a SPA and of an application for Fast Track status, and currently projects commencement of the Phase 3 study in the first half of 2008. A Special Protocol Assessment is a declaration from the Food and Drug Administration that a proposed Phase 3 trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval. All prior approved therapeutics suppress rather than eliminate autoimmunity and they have used the more limited indication of a reduction in the rate of progression of disability as their primary endpoint, not a reduction in disability as for Revimmune. Revimmune is the first drug to propose restoration of lost function in MS patients. Using a patent-pending, ultra-high intensity, short-course of an intravenous formulation of cyclophosphamide, Revimmune is intended to "reboot" a patient's immune system, thereby eliminating autoimmunity, whereas current therapies, including oral cyclophosphamide, are used chronically to attempt to suppress the inflammation of autoimmunity. Based on long-term follow-up with patients that showed complete remissions in previous studies, there is substantial evidence that Revimmune has the potential to cure cases of severe refractory autoimmune diseases, including aplastic anemia and myasthenia gravis. Revimmune uses a drug approved for other indications at other doses.
Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at the Johns Hopkins University School of Medicine, Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow. Investigators at Johns Hopkins discovered that stem cells are unique in having high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to a new immune system over two to three weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.
Revimmune can be administered as an inpatient or outpatient infusion for four hours per day for four consecutive days. The treatment is intended to allow patients to recover at home while their immune system reconstitutes itself over a two to three week period. Revimmune includes a risk management program to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data.
The principal investigator for the Phase 2 study with Revimmune at Johns Hopkins University School of Medicine is Dr. Douglas Kerr, associate professor of neurology. The co-principal investigators on this study are Dr. Daniel Drachman, Dr. Robert Brodsky, and Dr. Adam Kaplin. The National Multiple Sclerosis Society has supported the clinical protocol at Johns Hopkins University.
In my opinion your are looking at a company that has current deeply discounted shares. Accentia already does about $20 million in current revenue that has 2 FDA Fast Tracked Phase 3 drugs in the end stages of their trials which both carry Multi-billion dollar potential. They also announced a new proposed Phase Three Trial for the treatment os Multiple Sclerosis which could be wrapped up by the second half of 2009 that has multi-billion dollar market potential as well. Shares can be had for just under $3.00.00 per share. If this company was to get the green light on on of these products I could see shares trading near $20.00.00 quickly.
Disclosure: Author has a long position in ABPI