Soligenix Announces Positive Survival Results of SGX202 in Radiation Injury; $SNGXD

Soligenix, Inc. (OTCBB: SNGXD) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix's lead product, orBec® (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of allogeneic hematopoietic cell transplantation.

The company announced additional promising preliminary results from "its continuing preclinical study of SGX202 (oral beclomethasone dipropionate or BDP) in a canine gastrointestinal acute radiation syndrome (GI ARS) model." These new study results indicate that dogs treated with SGX202 beginning "24 hours after exposure to lethal doses of total body irradiation (TBI) demonstrated statistically significant (p=0.04) improvement in survival when compared to control dogs. This study builds upon the previous results which showed statistically significant survival in dogs when dosing of SGX202 was initiated two hours after lethal doses of TBI."

George Georges, MD, Associate Member of the Clinical Research Division at Fred Hutchinson Cancer Research Center and Principal Investigator for the study, commented,

"These 24 hour post-exposure results confirm earlier findings and suggest that SGX202 may significantly improve survival from GI ARS. SGX202 may potentially inhibit the cellular and innate immune mechanisms within the gut mucosa that exaggerate mucosal damage, and improve GI recovery after radiation. In the challenging area of radiation injury, the second study also met its primary objective in protecting dogs from GI ARS and extending their survival. We are completing our analysis of the data so that we may extend our investigations of SGX202 in GI recovery after radiation exposure and build upon these promising results."

Christopher J. Schaber, PhD, Chief Executive Officer of Soligenix, added,

"We are very pleased with the results to date with SGX202 in GI ARS. Based on these data and our positive preliminary interactions with both the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), it is our intent to continue to seek additional funding for the continued development of SGX202."

The study was supported by a $1 million grant from the NIAID.

Read the full article at Drugs.com. 

Dendreon (DNDN): Reports Monday Feb 27 at 9:00 am

Dendreon Announces New Time for Fourth Quarter and Year-End Financial Results Conference Call and Webcast Presentations at Upcoming Conferences

Call to be held on Monday, February 27, 2012, at 9:00 a.m. ET

SEATTLE--(BUSINESS WIRE)-- February 22, 2012 — Dendreon Corporation (Nasdaq: DNDN) today announced that management will host a conference call on Monday, February 27, 2012, at 9:00 a.m. ET to review fourth quarter and year-end financial results. This conference call was previously scheduled at 4:30 p.m. ET on the same date.

Access to the discussion may be obtained as follows:

Time:						9:00 a.m. ET / 6:00 a.m. PT
Date:						February 27, 2012
Dial-in:						1-877-548-9590 (domestic) or +1-720-545-0037 (international);
						conference pass code: 46511476
Webcast:						www.dendreon.com (homepage and investor relations section)

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-800-585-8367 or +1-404-537-3406 for international callers; the conference ID number is 46511476. The replay will be available from 12:00 p.m. ET on Monday, February 27, until 11:59 p.m. ET on Monday, March 5. In addition, the webcast will be archived for on-demand listening for 90 days at www.dendreon.com.

In addition, Dendreon Corporation also announced that management will present at the following conferences:

• RBC Capital Markets' Healthcare Conference in New York City, on February 28, 2012, at 3:35 p.m. ET
• Citi 2012 Global Healthcare Conference in New York City, on February 29, 2012, at 2:00 p.m. ET

The presentations will be audio webcast live and available for replay from Dendreon's website, www.dendreon.com. If you are unable to listen to the live webcasts, they will be archived on the site following the presentation. To access the replays, go to the Investor Relations section of the website.

Daily Dose Conclusion: Look for strong numbers this time around in Dendreon but remember that good numbers are baked intot he current share price that has rebounded from the lows this summer.  Immunocellular (IMUC) is a compelling value play to Dendrion these days.

New York Stem Cell Summit - Tuesday in NYC

Venue: Bridgewaters New York

TIME: Runs 8 am – 7 pm Tuesday only

Location: 11 Fulton Street, atop the Fulton Market Building at the South Street Seaport

Company list: http://stemcellsummit.com/agenda.html  THERE IS ONLY ONE TRACK OF PRESENTATIONS

Athersys

Biotime

LifeNet Health

Mesoblast

Osiris

Vet-Stem

INCELL

Parcell Laboratories

AllCells

Orthopedic Stem Cell Institute

AlloSource

Core Dynamics

Gamida Cell

CellGenix GmbH

Lonza

PCT

(LUNCH BREAK)

TiGenix

NeoStem

Pluristem

Tissue Genesis Inc

Xpand biotechnology

Aldagen

Garnet Biotherapetics

CTI Clinical Trial and Consulting Services

Celtigen Therapeutics

Histogen

Pathfinder

Pervasis Therapeutics

IntelliCell BioSciences

Histogenics

The Biotech Bull Market Is Just Getting Started @ Growth Stock Wire

According to an article on GrowthStockWire.com by Larsen Kusick, the  lead analyst for the exclusive Phase 1 Investor advisory, the biotech sector is on its way up. He cited Roche's $5.8 billion bid to buy Illumina, Bristol-Myers' $2.5 billion offer for Inhibitex, and Amgen's $1.2 billion bid for Micromet as "part of a larger trend that's propelling the whole biotech sector to new highs. And it's just getting started."  

Kusick pointed out that while "Big Pharma companies have tons of cash...these companies aren't growing." The average sales growth this year for companies like Johnson & Johnson, Pfizer, Amgen, Merck, Roche and others is negative 0.6%. These companies are "losing billions of dollars in revenue as blockbuster drugs, like Lipitor, go off patent and have to compete with cheaper generic versions. Big Pharma executives realize the only way to boost revenue growth, while earning a reasonable return on their investment, is to buy biotech assets at distressed prices."

He predicted that "a growing buyout bonanza would put a solid bid beneath biotech stock prices. The sector is already rocketing off its 2011 lows." The chart below illustrates his point:

He concluded, "if Big Pharma puts more of its cash to work this year, the uptrends here are just the beginning."

Read the full article at GrowthStockWire.com. 

BBC: Stem cells used to 'heal' heart attack scars

An exciting article appeared in the BBC many weeks ago, and continues to cycle through the media. It has to do with some exciting but early work done in the area of expanding heart cells (myocytes).

_________________________________

Damage caused by a heart attack has been healed using stem cells gathered from the patient's own heart, according to doctors in the US.

The amount of scar tissue was halved in the small safety trial reported in the Lancet medical journal.

The authors said there was also an "unprecedented" increase in new heart muscle.

The British Heart Foundation said it was "early days", but could "be great news for heart attack patients". A heart attack happens when the organ is starved of oxygen, such as a clot blocking the flow of blood to the heart.

As the heart heals, the dead muscle is replaced with scar tissue, but because this does not beat like heart muscle the ability to pump blood around the body is reduced.

Doctors around the world are looking at ways of "regenerating" the heart to replace the scar tissue with beating muscle. Stem cells, which can transform into any other type of specialised cell, figure prominently in their plans.

Heart to heart

This trial, at the Cedars-Sinai Heart Institute, was designed to test the safety of using stem cells taken from a heart attack patient's own heart.

Healing the Heart

This is the second group of doctors to report using cells taken from a heart to heal a heart. In November 2011, another safety trial showed the cells could be used to heal the hearts of heart failure patients who were having heart bypass surgery. The heart is not the only source for these stem cells and other fields are much further ahead.

The largest ever trial of stem cell therapy in heart attack patients is about to get under way in Europe. The BAMI trial will inject 3,000 heart attack patients with stem cells taken from their bone marrow within five days of the heart attack.  {(We know a little bit about this trial, it is based on bone marrow derrived cells that home to the peri-infarc zone via an ischemic gradient.  This is very similar to the mechanism of action that NeoStem's (NBS) Amorcyte claims on their bone marrow derrived cells (CD 34+ /CXCR4+) enriched marrow cells, injected into the IRA (infarc related artery). The BAMI trial is similar in design to NBS trial but with a few major differences. The product is not enriiched for CD 34+ cells and the dose is not as concentrated).}

• Cardiac cells 'heal heart damage'

Within a month of a heart attack, a tube was inserted into a vein in the patient's neck and was pushed down towards the heart. A sample of heart tissue, about "half the size of a raisin", was taken. This was taken to the laboratory where the stem cells were isolated and grown. Up to 25 million of these stem cells were then put into the arteries surrounding the heart. Twenty five patients took part in the trial. Before the treatment, scar tissue accounted for an average of 24% of their left ventricle, a major chamber of the heart. It went down to 16% after six months and 12% after a year. Healthy heart muscle appeared to take its place. The study said the cells, "have an unprecedented ability to reduce scar and simultaneously stimulate the regrowth of healthy [heart] tissue".

One of the researchers Dr Eduardo Marban said: "While the primary goal of our study was to verify safety, we also looked for evidence that the treatment might dissolve scar and regrow lost heart muscle. "This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it. "The effects are substantial, and surprisingly larger in humans than they were in animal tests."

 Dr. Iqbal Malik: ''This is one small step''

However, there was no increase in a significant measure of the heart's ability to pump - the left ventricle ejection fraction: the percentage of blood pumped out of the left ventricle.

Prof Anthony Mathur, who is co-ordinating a stem cell trial involving 3,000 heart attack patients, said that even if the study found an increase in ejection fraction then it would be the source of much debate.

He argued that as it was a proof-of-concept study, with a small group of patients, "proving it is safe and feasible is all you can ask".

"The findings would be very interesting, but obviously they need further clarification and evidence," he added. Prof Jeremy Pearson, associate medical director at the British Heart Foundation, said: "It's the first time these scientists' potentially exciting work has been carried out in humans, and the results are very encouraging. "These cells have been proven to form heart muscle in a petri dish but now they seem to be doing the same thing when injected back into the heart as part of an apparently safe procedure.

"It's early days, and this research will certainly need following up, but it could be great news for heart attack patients who face the debilitating symptoms of heart failure."

Prima BioMed files for NASDAQ listing (ASX: PRR)

Just a quick heads up that Australian biotech company Prima BioMed (ASX: PRR) has filed for a NASDAQ listing of American Depositary Receipts (ADR). Once the listing is complete the company will have a dual listings of its securities on both the Australian Securities Exchange (ASX) and NASDAQ. Every one ADR will represent 30 common shares, so Prima at $0.17 cents would trade at $5.10 and a market cap of >$160 mln.

Prima’s proposed NASDAQ listing will be a Level II ADR compliance listing, and is being managed by Bank of New York Mellon and US broking houses Deutsche Bank AG, Noble Financial and Aegis. Prima did say that they are currently unable to say precisely when the shares will actually list and trade but we expect it will be soon.

Here the big question: Is this a blessing or a Curse ?

Prima is listing on the NASDAQ for better exposure and most importantly access to U.S. capital markets. The company is now beginning a Phase III trial in ovarian cancer using a dendritic cell based vaccine (in the U.S., Progenitor Cell Therapy (NeoStem-NBS) is doing the manufacturing, recall that PCT did the clinical work for Dendreon's Provenge and is also working for Coronado (CNDO) and Immunocellular (IMUC). If anyone can make sure that the "manufacturing goes off with-out a hitch” its PCT-NBS. 

So the next big question, is does it work ? Ovarian is a very tough indication and the life expectancy of Ovarian cancer varies a great deal. Prima's Phase II data was not double blinded cross-over so the results are not definitive. No way to say what the results of the current global PIII trial will be yet. We do know Prima will likely need to raise capital at some point ahead (thus the U.S. listing).

Perhaps the most important event that investors will watch will be not Prima at all, but Merck KG who is running the StimuVax trial which like Prima's product (C-Vac) targets the MUC-1 antigen (over-expressed in ovarian cancer).

If StimuVax works, Prima could rock, if not, it could flop as it validates one way or another the MUC-1 antigen as a target.

Let’s watch Prima and see how the company does as they work to build a U.S. institutional presence and present their data to the scrutiny of US investors.

Soligenix (SNGXD): Acute Radiation Syndrome (ARS)-GI, Shows Positive Data

Soligenix (OTCBB: SNGXD) announced results from its phase 1/2 clinical trial of SGX201 for the prevention of acute radiation enteritis. The press release covers how the study demonstrated that oral administration of SGX201 (beclomethasone) was safe and well tolerated across all four dose groups.

There was also evidence of a potential dose response with respect to diarrhea, nausea, and vomiting and the assessment of enteritis according to NCI Common Terminology Criteria for Adverse Events for selected gastrointestinal events. In addition, the incidence of diarrhea was lower than that seen in recent published historical control data in this patient population.

Osiris (OSIR): Follow-Up comments from News that Sanofi has walked Away from Osiris

Osiris Therapeutics (NASDAQ: OSIR): It has now been learned that corporate partner Genzyme/Sanofi not only discontinued Prochymal's development but didn’t even formally notified Osiris. They found out the same way we did ! OSIR is saying that these "public statements" effectively terminate the agreement" giving all rights for Prochymal back to Osiris. So Osiris gets 100% of Prochymal back but does anybody want it now?

The next event for investors to watch will be Prochymal’s Canadian filing for GvHD in 1H12 (expected to be negative) and as such this could trigger further decline in the shares. Recall that Prochymal failed to reach its primary endpoints in two Phase 3 trials.

Daily Dose Conclusion: Sanofi decision is not totally unexpected but is disappointing as the hope has been that a "big-pharma" would support prochymal. While negative for the space over-all (cell therapy) we see this as both an issue specific to Osiris and to Prochymal and to the disease, GvHD which has been riddled with failures. Osiris lacks few drivers to the upside, with risk to the downside.