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.

AlloCure (private) Raises $25 million in series B for Cell Therapy in Kideny Disease

Allocure Inc. (Burlington, Mass.) raised $25 million in a series B round. New investor Lundbeckfond Ventures joined existing investors SV Life Sciences and Novo A/S in the round. AlloCure plans to start Phase II testing this summer of AC607 to treat acute kidney injury.

AC607 is a novel biologic therapy under development for the treatment of AKI. AC607 also possesses potential applications in other grievous illnesses. AC607 comprises allogeneic bone marrow-derived mesenchymal stem cells that are harvested from healthy adult donors and then expanded via a mature and state-of-the art manufacturing process. AC607 homes to the site of injury where it mediates powerful anti-inflammatory and organ repair processes via the secretion of beneficial paracrine factors, without differentiation and repopulation of the injured kidney. Importantly, AC607 avoids recognition by the host's immune system, enabling administration in an "off the shelf" paradigm without the need for blood or tissue typing.

The capital just raised will be used to support the next step of clinical development: "Building on the encouraging AC607 Phase 1 results presented last fall at the American Society of Nephrology annual meeting, AlloCure is poised to conduct a multicenter, randomized, double-blind, placebo controlled trial of AC607 for the treatment of AKI beginning this Summer at a number of the leading academic institutions and hospitals in the United States.

StemCells ($STEM) Announces webcast to discuss Pelizaeus-Merzbacher disease clinical trial results

A summary of the trial results will be presented on Saturday, 31-Mar, at the 2012 European Leukodystrophy Association (ELA) Families/Scientists Meeting in Paris:

• Webcast: Monday, 2-Apr, at 11:00ET 
• http://investor.stemcellsinc.com/phoenix.zhtml?c=86230&p=irol-irhome

BackGround: What is Pelizaeus-Merzbacher Disease (PMD) ?

PMD is a myelination disorder that primarily affects young children. It is a rare central nervous system disorder in which coordination, motor abilities, and intellectual function are delayed to variable extents. In November of 2009 STEM began a trial at the University of California, San Francisco (UCSF) Benioff Children's Hospital. In February 2010 the cells were used to treat the first patient enrolled in the trial, marking the first time that neural stem cells have been transplanted as a potential treatment for a myelination disorder.  In February 2011, the fourth and final patient was enrolled and dosed.  Results of the trial will be reported on Monday (see link above).

This Phase I trial has been designed to assess the safety and preliminary efficacy of STEM's HuCNS-SC cells as a potential treatment for PMD. While the primary focus in this first trial is safety, the company is looking for evidence of new myelin formation in the patients’ brains following the transplantation of the cells, as well as any signs of improved neurological function.

The four enrolled patients have connatal PMD, the most severe form of the disease. All patients were transplanted with the HuCNS-SC cells and were evaluated regularly over a 12-month period in order to monitor and evaluate the safety and tolerability of the HuCNS-SC cells, the surgery and the immunosuppression. In addition, MRI examination of the brain post-transplant should enable the measurement of new myelin formation. The company is hoping to follow the effects of this therapy long-term, so,we expect a four-year observational study to be reviewed.

Daily Dose Conclusion: This is cutting edge science. Safety come first but STEM is moving in areas that represent totally unmet medical needs. The tough financing environment as hurt the whole stem cell sector but the science is marching forward. STEM remains a pioneer with their HuCNS-SC technology.

Myelination Disorders / PMD (continued)

The gene mutations responsible for PMD result in improperly produced or too much proteolipid protein (PLP), which proves toxic to oligodendrocytes, the CNS cells that produce myelin. Myelin, comprised of fats, cholesterol and protein, is critical to healthy functioning of the central nervous system because it provides the insulation needed for proper transmission of nerve impulses.

In myelination disorders, the deficient myelin sheath does not properly insulate the axon, so transmission of nerve impulses is impeded.

Neuron with deficient myelin

The StemCells Approach: Myelin Production to Protect Nerve Cells

When StemCells human neural stem cells are transplanted in animals, they migrate to the sites where myelin is deficient. They differentiate into oligodendrocytes, which form healthy myelin sheaths to protect axons, helping nerve cells communicate with each other. They do this by developing myelin appendages that wrap around the axons of nearby neurons to provide the insulation (myelin) needed for proper transmission of nerve impulses.

HuCNS-SC^® Cell

Oligodendrocyte forms healthy myelin sheath around axon.

Neuron

Oligodendrocyte

Normal transmission of nerve impulses.

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Cytomedix ($CMXI) Reports 2011 Fourth Quarter and Full Year Financial Results

Daily Dose Commentary: According to their press release, CMXI is tight on cash: “Cash and cash equivalents as of December 31, 2011 were $2.25 million compared with $0.64 million
as of December 31, 2010. The Company used $4.24 million to fund operating activities during 2011”. The key question is how will they move forward with Aldagen’s clinical programs ?

Cytomedix, Inc. (OTCBB: CXMI) is a biotechnology company developing advanced tissue regeneration technologies. Their primary focus is on commercializing autologous cell based therapies that facilitate the body’s natural healing processes for enhanced healing and tissue repair.  Their commercial portfolio is based on autologous platelet rich plasma (“PRP”) platform technology, and includes the Angel® Whole Blood Separation System (“Angel®”) and the AutoloGel^TM System (“AutoloGel”). 

Cytomedix (OTC/BB: CMXI) announced its financial results for the fourth quarter and year ended December 31, 2011.  The Company reported a total revenue increase of 129% to $2.96 million from $1.29 million the prior quarter and a year total revenue increase of 85% to $7.25 million from $3.91 million in 2010.  The Company attributed the increase to higher sales of the Angel and AutoloGel Systems as well as a non-refundable option fee.  

Chief Executive Officer of Cytomedix Martin P. Rosendale commented,

 "2011 was an exceptional year for Cytomedix, and was one in which we significantly strengthened the Company and positioned it for future growth and business expansion. The Angel business continues to grow nicely, posting double-digit sales increases, and we have made substantial progress with the AutoloGel system both with business development and reimbursement initiatives. We significantly strengthened our balance sheet with the early retirement of the remaining debt from the Angel acquisition and the $2.0 million non-refundable option payment received from our potential strategic global pharmaceutical partner for AutoloGel. Importantly, we recently expanded our commitment to regenerative medicine with the acquisition of Aldagen in February 2012, and we are now a significantly more diversified business with both commercial products and a robust pipeline of promising regenerative technologies."

Read the full press release here.  

NeoStem Announces Pricing of Public Offering for $6,000,000 in Gross Proceeds (NBS)

NeoStem, Inc. (NYSE Amex:NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.  Its January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy. 

 

The Company has announced "the pricing of an underwritten public offering of 15,000,000 units at $0.40 per unit. Each unit consists of one share of common stock and a warrant to purchase one share of common stock with a per share exercise price of $0.51. Maxim Group LLC acted as sole bookrunner. The Company expects to receive $6,000,000 in gross proceeds, prior to deducting underwriting discounts and commissions and offering expenses payable by the Company."

These funds will be used for working capital purposes such as the research and development of cell therapeutic product candidates, as well as the expansion of business units, strategic transactions and other general corporate purposes. Neostem "has granted the underwriters a 45-day option to purchase up to an additional 2,250,000 units to cover over-allotments." 

 

The financing is expected to close on or about April 3, 2012, subject to the satisfaction of customary closing conditions.

Read more at Nasdaq.com. 

Islet Sciences Announces DiaKine Therapeutics' Novel Diabetes - $ISLT

Islet Sciences, Inc., (OTCBB: ISLT) is a biotechnology company engaged in the research, development and commercialization of patented technologies in the field of transplantation therapy for patients with diabetes.The company is based on prior technology that originated from islet biosciences. The company is pioneering the use of porcine (pig) islet cells encapsulated in an algenate bubble and transplanted into type 1 diabetics that will then function to produce insulin. The potential of this therapy to change the diabetes paradigm could be dramatic.

Today they announced that its subsidiary DiaKine Therapeutics Inc. received European patent protection. The drugs are small molecules that can be used to treat diabetes, atherosclerosis and other inflammatory diseases.

The European patent (#1919867), issued on March 16, 2012, covers the composition and methods of use of orally active drugs with a novel mechanism to reduce autoimmunity and inflammation. In particular, the small molecules have the potential to protect insulin-producing cells from inflammation, reduce insulin resistance, and prevent or treat cardiovascular disease, making them ideally suited for the treatment of type 1 and type 2 diabetes, atherosclerotic cardiovascular disease and other conditions associated with activation of the body's Interleukin 12/STAT4 Pathway.

"Inflammation is a major link associated with the development of diabetes and its complications," said Dr. Jerry L. Nadler, the company's chief science officer and chairman of the board. "This European patent strengthens DiaKine's ability to address diabetes and to meet a medical need for the treatment other inflammatory diseases, such as atherosclerosis and autoimmune disorders."

"This patent issuance is a clear testament to the value of our therapies which represents a large market opportunity for Islet Sciences," said John Steel, Chairman and CEO of Islet Sciences. We are pleased to announce this milestone which clearly strengthens our value proposition."

The compounds were first developed at the University of Virginia and licensed to DiaKine by the U.Va. Patent Foundation (now the U.Va. Licensing & Ventures Group) http://www.innovation.virginia.edu.

See the full press release @ Yahoo Finance

Oncothyreon ($ONTY): Raising Capital as Rodman Re-itts the Buy Rating: "Down but not out - PX866 to drive value in 2012"

Oncothyreon ($ONTY) is a biotechnology company dedicated to the development of oncology products that can improve the lives and outcomes of cancer patients. The company is currently developing multiple therapeutic candidates designed to target cancer in specific and effective ways. The pipeline includes both synthetic vaccines and small molecules for a variety of cancer indications. 

Rodman & Renshaw has released a report on Oncothyreon, classifying it as "Outperform" with a "Speculative Risk." The report includes the following investment opinion:  

 

"We are reiterating our Market Outperform rating and 12-month price target of $10 per share for Oncothyreon. Our price target is based on a 2015 discounted revenues and earnings per share multiples analysis. Although the second interim analysis did not live up to investor’s expectations, we continue to believe in the Stimuvax story. The recent data highlights the therapeutic value of Stimuvax, and also serves to validate Oncothyreon’s MUC1 based vaccine technology platform. In addition to Stimuvax and ONT-10, Oncothyreon possesses a broad oncology pipeline, which includes PX-866 (an irreversible inhibitor of PI3K) and ONT-701 (a newly acquired pan Bcl-2 inhibitor)." 

Our Thoughts: Ovarian is a great indication, unmet medical need but tough to crack. Oncothyreon has postponed results but that may not be  bad thing, perhaps patients are living longer. We saw some news of a capital raise underwritten by Cowen and Stifel Nicolas.

Watch this name and the data as it rolls out, it will also impact dendritic cell company, Prima BioMed that chasing the same MUC-1 target.

Rodman Renshaw Report on ONTY

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FDA Starts scrutinizing how adipose tissue is used @ Intellicel Bio - $SVFC

Judging by a recent "warning letter" issued to the CEO of Intellicell Biosciences (OTCQB: SVFC), the FDA is getting stricter regarding the processing of adipose tissue. 

 

The letter, which was posted on the FDA website, regards Intellicell's processing of adipose tissue for use in orthopedic therapies. Intellicell is a company processing adipose tissue, claiming their “ultrasonic cavitation” technology is only minimally manipulated; hence they fall under less FDA scrutiny (ie, no FDA approval required).

It seems that the FDA is concerned about how this specific process may be changing the structural characteristics of the adipose tissue (fat) itself. It appears that regardless of the process the FDA seems to be considering the product as a drug. 

 

The letter includes the following excerpt:

"IntelliCell’s adipose derived stem cells are human cells, tissues, or cellular and tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d). However, this cellular product does not meet all of the criteria in 21 CFR 1271.10(a) and therefore is not regulated solely under section 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264] and the regulations in 21 CFR Part 1271. Specifically, your processing alters the relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement. Therefore the processing would not meet the definition of minimal manipulation for structural tissue such as adipose tissue. As a result, the IntelliCell product does not meet the criterion in 21 CFR 1271.10(a)(1)." 

See the full letter on fda.gov.