Interview with Nobel Prize Winner Dr. Harold Varmus

Dr. Harold Varmus, the current Director of the National Cancer Institute, visited our studio for an interview with JCI's Executive Editor Dr. Ushma Neill, as part of the Conversations with Giants in Medicine video series. Those videos, produced in collaboration with the Journal of Clinical Investigation and hosted on their Web TV, show interviews with Nobel Prize winners and renown scientists.

After talking about what led him to the scientific field, Dr. Varmus reviews his productive career and accomplishments in science and medicine. He also describes his research in cells and cancer treatment that resulted in a Nobel Prize win.

Prior to his work as the Director of the National Cancer Institute, Dr. Varmus worked as the Director of the National Institutes of Health from 1993 to 1999 and the President of Memorial Sloan Kettering Cancer Center from 2000 to 2010. He received the Nobel Prize in Physiology of Medicine with Michael Bishop in 1989. This prize meant recognition of their discovery of the cellular origin of retroviral oncogenes, which allows us to understand and treat cancer and know how cells live and grow today.

Photo credit: National Cancer Institute.

Access Pharmaceuticals to Report New MuGard Clinical Trial Data This Week at the MASCC/ISOO Symposium in New York City (ACCP)

Access Pharmaceuticals, Inc. (OTCBB: ACCP) is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation platinum chemotherapeutic drug and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers; currently in a Phase 1/2a trial in hematological malignancies at M.D. Anderson Cancer Center in Houston, Texas. 

The Company has announced that it will be presenting at a joint international symposium of the Multinational Association of Supportive Care in Cancer (MASCC) and the International Society of Oral Oncology (ISOO) on Supportive Care in Cancer, in which the results of a recent interim analysis of data from an ongoing MuGard clinical trial will be shared.

On Thursday June 28th, a podium presentation will be made by one of the lead investigators in the study, and on Friday June 29th results will be presented in a poster on display. In addition to these presentations, "Access will have its MuGard booth in the commercial exhibit hall to educate the attendees on the clinical benefit MuGard offers patients undergoing cancer treatment. The annual MASCC/ISOO Symposium is the preeminent international conference to focus on supportive care in oncology and will be held this week at the Hilton New York Hotel on Thursday, June 28th – Saturday, June 30th."

Read more at PRNewswire.com. 

Zacks on Access Pharmaceuticals: MuGard sales continued to grow in 1Q12 and will keep current momentum; Outperform (ACCP)

Access Pharmaceuticals (ACCP) is an emerging biopharmaceutical company specializing in products for cancer and supportive care. Access currently has one FDA-approved product, two products in Phase II clinical development, three products in preclinical development. Several of the company's products are based on Access' proprietary nanopolymer technologies which provide enhanced drug delivery options for both new and approved pharmaceutical active ingredients.

Zacks.com has released a report on Access Pharmaceuticals entitled "MuGard sales continued to grow in 1Q12 and will keep current momentum." Zacks maintains an "Outperform" rating on ACCP but lowers the price target. 

Purchase the report online at AlacraStore.com. 

Coronado Biosciences receives recommendation to continue Falk phase 2 trial of TSO in Crohn's disease

Coronado Biosciences, Inc. (Nasdaq: CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that it received from Dr. Falk Pharma GmbH (Falk), its development partner, a recommendation from the independent data monitoring committee that conducted an interim analysis (blinded to Falk) of clinical data from the initial 120 patients to continue Falk's Phase 2 clinical trial in Europe evaluating Trichuris suisova (TSO) in Crohn's disease. The committee noted no safety concerns and a positive efficacy trend in its recommendation that the study continue. See the full release @

http://www.proactivenewsroom.com/Blog/bid/85980/Coronado-Biosciences-Announces-Independent-Data-Monitoring-Committee-Recommendation-to-Continue-Falk-Phase-2-Trial-of-TSO-in-Crohn-s-Disease

Daily Dose Updates:

• CNDO received from Dr. Falk Pharma GmbH (Falk), its development partner, a recommendation from the independent data monitoring committee that conducted an interim analysis (blinded to Falk) of clinical data from the initial 120 patients to continue Falk's Phase 2 clinical trial in Europe evaluating Trichuris suis ova (TSO) in Crohn's disease.
• The committee noted no safety concerns and a positive efficacy trend in its recommendation that the study continue.
• Falk has advised they are adopting the committee's recommendations to increase the sample size and to conduct a subsequent interim analysis at the time the trial reaches approximately 250 patients.
• The Falk trial, entitled Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn's disease, is being conducted in Europe and was initially expected to enroll approximately 212 patients and to evaluate three different dosages of TSO versus placebo.

Northwest Biotherapeutics ($NWBO) completes significant milestones in DCVax-L program for brain cancer in Germany

Northwest Bioterapeutics (OTCBB: NWBO) joined the Fraunhofer IZI Institute in announcing that, working closely together over the course of more than 13 months, the parties have completed significant milestones in NW Bio's DCVax-L program for brain cancer in Germany.

• As a result, the company is poised to move forward in the near term in Germany with both its clinical trial program and Hospital Exemption cases under Section 4B of the German Drug Act
• A four-month long technology transfer of the manufacturing process for DCVax-L was carried out by NW Bio, its contract manufacturer, Cognate BioServices and Fraunhofer IZI. In addition, a multi-month process was completed to create the extensive documentation required to apply for manufacturing authorization in accordance with Section 13 of the German Drug Act (AMG), the application was submitted to the responsible pharmaceutical supervisory authority, and the 9-month long regulatory process has been completed up to the point of the official acceptance inspection.
• The parties are now awaiting that final inspection, which is the last step required before the manufacturing authorization can be granted and manufacturing can proceed for clinical trials and Hospital Exemption cases.
• The inspection is scheduled for June 2012.

Stemline Announces Plans to IPO

Stemline Therapuetics has announced their plans to raise up to $50 million in an IPO. JMP Securities and Oppenheimer have been selected as the banks.

The company hopes to begin a Phase IIb trial next year for two products:SL-401 (third-line acute myelogenous leukemia AML); and SL-701 for newly diagnosed brainstem glioma and second-line glioblastoma multiforme (GBM). Immunocellular (IMUC) is pursuing a similiar indication.  SL-401 is an IL-3 receptor targeting agent. SL-701 is a vaccine composed of alpha-type-1-polarized dendritic cells loaded with synthetic peptides for glioma-associated antigen epitopes plus adjuvant poly-ICLC

Researchers have identified Cancer Stem Cells (CSCs) as the highly malignant "seeds" of tumors, typically comprising 1-5% of the tumor, that give rise to the majority (95-99%) of other tumor cells known as the "tumor bulk".  While standard therapies, including chemotherapy and radiation, may initially shrink tumors by killing tumor bulk, the failure of these therapies to eradicate CSCs may be a major contributor to treatment failure, tumor relapse and poor survival.

Accordingly, we believe that new therapies designed to target CSCs, in addition to tumor bulk, may represent a major advance in the fight against cancer. This premise has formed the basis of our drug development strategy, as illustrated.

Dendreon Reports- Street is dissapointed by $DNDN

Daily Dose Conclusion: Dendreon reported sales of $77 million, annualizing that would be approx. > $300 mln in rev's. The stock trades today at a $1.8 bln market cap. at 5 x revenues = $1.5 bln but the current revenue run rate is likely to climb as the product penetrates deeper into the market place. A few of the wall street firms have been out with negative to neutral comments and the stock is trading lower, but longer term, we would expect to see DNDN trade up based on traditional valuation metrics.

Flash Player 9 or higher is required to view the chart
Click here to download Flash Player now

View the full DNDN chart at Wikinvest

Dendreon Reports Fourth Quarter and 2011 Year End Financial Results

SEATTLE--(BUSINESS WIRE)-- February 27, 2012--Dendreon Corporation (Nasdaq: DNDN) today reported results for the year and quarter ended December 31, 2011. Product revenue for the year ended December 31, 2011 was $213.5 million compared to $48 million for the year ended December 31, 2010. Product revenue for the fourth quarter of 2011 was $77 million compared to $25 million for the quarter ended December 31, 2010.

The net loss for the year ended December 31, 2011 was $337.8 million, or $2.31 per share, compared to $439.5 million, or $3.18 per share for the year ended December 31, 2010. Net income in the fourth quarter of 2011 was $38.1 million or $0.26 per share, compared to a net loss of $91.8 million, or $0.64 per share, for the same period in 2010. The fourth quarter of 2011 included a royalty payment of $125 million associated with the sale of our VICTRELIS™ (boceprevir) royalty interest. Dendreon's total operating expenses, including cost of product revenue, for the year ended December 31, 2011 were $633.3 million compared to $340.2 million in 2010.

As of December 31, 2011, Dendreon had approximately $617.7 million in cash, cash equivalents, and short-term and long-term investments compared to $277.3 million as of December 31, 2010.

Recent Highlights:

• Announced the election of John H. Johnson to the position of president and chief executive officer (CEO) and Mitchell H. Gold, MD, as executive chairman, who will serve in that role until June 30, 2012, at which point he will continue to serve as a director and Mr. Johnson will become chairman.
• At the end of the fourth quarter, completed in-servicing for more than 840 total sites, of which:
  • More than 590 sites have infused PROVENGE® (sipuleucel-T).
  • Approximately 615 sites have either infused the product or have their patients scheduled for their first PROVENGE regimen.
• Improved PROVENGE reimbursement landscape for customers and patients:
  • Reported average time to payment is less than 30 days for physicians, which is better than industry standard, reflecting an improved reimbursement landscape due to a national coverage decision and activation of a Q-code that accelerates electronic adjudication of claims.
  • The Centers for Medicare and Medicaid Services (CMS) updated their coverage policy to now cover the infusion costs associated with the administration of PROVENGE. With this decision, the coverage of PROVENGE is now consistent with all other infused biologics.
  • A recent analysis suggests that approximately 75% of patients had minimal or no out-of-pocket costs for PROVENGE.
• Filed the marketing authorization application (MAA) for PROVENGE with the European Medicines Agency, which was validated in January.
• Began enrollment in its clinical study evaluating PROVENGE and abiraterone.

"Dendreon has embraced the challenge of introducing an entirely new treatment paradigm for an entirely new market and has made important progress towards establishing PROVENGE as the foundation of care," said John H. Johnson, president and chief executive officer.

Coronado: CNDO - Makes the NASDAQ

Coronado began trading on the NASDAQ as CNDO, and was off in its first day of trading, $6 (down $0.50). Coronado is a fascinating story in immunology on two fronts, on the cell therapy side with an NK cell that rebuilds patients immunity and the other product CNDO-201 is a "whip worm" product. Normally we would consider this a parasite but in this case, the ova from the porcine helminth Trichuris suis may work symbiotically in man, to help re-balance out of balance "auto-immune" system. A phase IIb trial is scheduled to begin in 1Q-2012 to treat Crohn's disease patients but the implications here could reach as far as Multiple Sclerosis (MS).

Please see our write-ups here on Daily Dose and also on the ProActive Coronado page. We know that National Securities and their army of 750 retail brokers helped raise the initial capital, (as they did for Ventrus -VTUS) last year to bring this company public. As of September, the company has $26.7 million in cash. Coronado starts trading with a strong retail following as management now works to create an institutional following.