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Accentia gets new financing, moves into MS drug market

Accentia Biopharmaceuticals Inc. said it has acquired the rights to a treatment in the late stages of development that is designed to help people with autoimmune diseases, including multiple sclerosis.

The deal calls for Accentia to pay royalties and issue stock warrants once the treatment is approved in the United States, according to a Feb. 28 filing with the Securities and Exchange Commission.

Tampa-based Accentia also said it raised about $20 million in cash through a new financing agreement with several institutional investors. The cash raised by issuing convertible debentures will be used to continue the company's strategy of acquiring late-stage drug candidates as well as for supporting ongoing clinical development programs, the company said in a separate SEC filing.

Immune system 'reboot'

The patent-pending treatment to which Accentia has acquired exclusive world-wide rights, Revimmune, uses an approved drug, cyclophosphamide, in a new patent-pending method to "reboot" a patient's immune system, eliminating the autoimmunity, according to a release. Current therapies including oral cyclophosphamide are used to try to suppress the inflammation of autoimmunity, the release said.

Accentia's agreement for the rights to Revimmune covers all of the estimated 80 autoimmune diseases that are currently recognised, but Accentia said its lead indication for the treatment is multiple sclerosis.

The technology was developed at John Hopkins University and initially licensed to Revimmune LLC. Revimmune is a portfolio company of Hopkins Capital Group II LLC.

Milestone payment

Accentia, is managing partner of Hopkins Capital Group.

Accentia sublicensed the technology from Revimmune, the SEC filing said. Accentia will pay Revimmune a royalty of 4 percent on net sales and issue vested warrants to purchase 800,000 shares of Accentia stock at an exercise price of $8 a share. Accentia also will make a milestone payment of up to $50,000 at the issuance of the first patent and $100,000 at the first FDA product approval, the filing said.

Acquiring the rights to Revimmune is in keeping with Accentia's strategy of developing late-stage clinical products based on already approved pharmaceuticals, O'Donnell said in the release. It's a similar tack Accentia took for its lead product, SinuNase, designed for people with chronic sinusitis, which is in Phase 3 clinical trials.

Source: Tampa Bay Business Journal © 2006 American City Business Journals, Inc

Accentia Biopharmaceuticals Inc. said it has acquired the rights to a treatment in the late stages of development that is designed to help people with autoimmune diseases, including multiple sclerosis.

Interesting because there was a study not too long ago in which they seemed to find cyclophosphamide ineffective on MS. Because a little farther into this article they talk about "rebooting", I assume the "treatment" accentia purchased involves high dose cyclophosphamide, which as far as I can tell seems highly effective.

High-dose cyclophosphamide for moderate to severe refractory multiple sclerosis.
Department of Medicine, State University of New York at Stony Brook, USA. dgladstone@notes.cc.sunysb.edu

BACKGROUND: High-dose cyclophosphamide is active in immune-mediated illnesses. OBJECTIVE: To describe the effects of high-dose cyclophosphamide on severe refractory multiple sclerosis. DESIGN, SETTING, AND PATIENTS: Patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) score of 3.5 or higher after 2 or more Food and Drug Administration-approved disease-modifying therapy regimens were evaluated. INTERVENTIONS: Patients received 200 mg/kg of cyclophosphamide over 4 days. MAIN OUTCOME MEASURES: Patients had brain magnetic resonance imaging and neuro-ophthalmologic evaluations every 6 months and quarterly EDSS and quality-of-life evaluations for 2 years. RESULTS: Twelve patients were evaluated for clinical response (median follow-up, 15.0 months; follow-up range, 6-24 months). During follow-up, no patients increased their baseline EDSS scores by more than 1.0. Five patients decreased their EDSS scores by 1.0 or more (EDSS score decrease range, 1.0-5.0). Two of 11 patients had a single enhancing lesion at baseline; these lesions resolved after high-dose cyclophosphamide treatment. At 12 months, 1 patient showed 1 new enhancing lesion without a corresponding high-intensity T2-weighted or fluid-attenuated inversion recovery signal. Patients reported improvement in all of the quality-of-life parameters measured. Neurologic improvement involved changes in gait, bladder control, and visual function. Treatment response was seen regardless of the baseline presence or absence of contrast lesion activity. Patient quality-of-life improvement occurred independently of EDSS score changes. In this small group of patients with treatment-refractory multiple sclerosis, high-dose cyclophosphamide was associated with minimal morbidity and improved clinical outcomes. CONCLUSIONS: High-dose cyclophosphamide treatment in patients with severe refractory multiple sclerosis can result in disease stabilization, improved functionality, and improved quality of life. Further studies are necessary to determine the most appropriate patients for this treatment.

PMID: 16908728 [PubMed - indexed for MEDLINE]

Interesting press release
http://www.eurekalert.org/pub_releases/ ... 022807.php

That is a very interesting press release. Thanks Connie.

I've been really interested in HDC since Ian posted that video file which showed the lady playing fetch with the dog despite the fact that she had been in a wheelchair shortly before.

Of course few people are going to hop out of their wheelchairs but HDC does seem to be very effective in stopping the disease.

I still think that if nothing else this is an interesting lesson in that HDC leaves the bone marrow unscathed yet seems to be very effective in ending the MS/autoimmune process.

To me that seems to mean that the bone marrow isn't responsible for creating immune cells which attack self, evidently they "learn" that at some later point. From my limited understanding that only leaves the thymus where they mature or in the process of dividing?

Bob

Does anyone know what "refractory multiple sclerosis" is? I have never heard this term before and am not having much luck trying to find info on this term.

The best definition that I have found is that refractory refers to diseases in which treatments are not working. Now I don't know if this treatment is used only when all others fail or if it will be a primary treatment.

This drug sounds very promising. The info I found indicates it is in 3rd stage of clinical trials, so it shouldn't be too far away.

gwa

To me that seems to mean that the bone marrow isn't responsible for creating immune cells which attack self, evidently they "learn" that at some later point. From my limited understanding that only leaves the thymus where they mature or in the process of dividing?

I think that's correct... at least, that's my interpretation. I would be a bit nervous if the immune system was rebooted completely from scratch, because that would leave us with the immune system of a newborn baby, but if this therapy is selective, then it is really promising.

Gwa, "refractory" usually refers to something whitch does not respond, or has stopped responding, to treatment either initially or later on, if Revimmune works when other treatments don't, I would say, "what's the point of trying the others?" , go straight for it as the primary option!

Dom.

dom,

You said exactly hat I was thinking, in other words why keep trying other drugs that don't work so that you can take Revimmune, which does work.

It would appear that those of us who are SSPS or PPMS may have a shot at this drug.

gwa

Going from memory from last fall, and my memory isn't great, I remember Campath being a little more selective than high dose cyclophosphamide. I think I remember reading that HDC killed all the white blood cells and Campath kills all the T cells?

A good thing about high dose cyclophosphamide, from what I've been able to tell, is that after the original treatment regimine you don't seem to have to take any medications again.

The bad thing is that it's strong chemo and causes your hair to fall out. As Twisted mentioned, I'm pretty sure it leave you with no immune system for a while. It does leave the bone marrow unscathed so the situation is better than waiting for the creator of the immune system AND the immune system to regrow.

I've read that cyclophosphamide has been used for many years for cancer and has a known history, which isn't awful.

If someone really is interested, of course they won't want to rely on my memory and will want to research it for themselves, but I do remember not finding anything discouraging about it.

Bob

Of course there are some encouraging stories of success using HDC.

But in my eyes HDC can't be considered as a general cure, because in the followup (at most for 2 years) there still was an EDSS increase up to 1.

During follow-up, no patients increased their baseline EDSS scores by more than 1.0