As I wrote in mid-October as part of a commercial / clinical update article on MuGard, the $1.55 million in cash / equivalents for Access Pharma (OTC: ACCP.OB) as of mid-August would normally be a major concern for most companies. However, it should be noted the cash burn rate for the Company is very low (i.e. $241,000 per month or about $0.72M per quarter through 1H09). Also, Mr. Davis confirmed at the time of my previous article that the current liquidity is sufficient to fund operations through mid-2010 without even considering any MuGard royalties from Europe or the potential for upfront cash in a North American licensing deal for this product or any others in development such as oral insulin.

Since SCO Capital also has the perspective a major investor / shareholder in Access, additional equity capital from institutional investors should be considered a positive development for the reasons outlined below. A conservative capital raise of $10-15 million would be reasonable considering a fully diluted market cap of approximately $70 million at this time, which would be about half of the $25 million maximum offering of common stock and warrants in the SEC S-1 filing that was made on 10/27/09.

1.) to secure a stock listing on AMEX or NASDAQ (to address positive net equity requirements which arise due to previously applied accounting standards for in-process R&D from acquisitions);

2.) to provide a stronger negotiating position for licensing the rights to MuGard in North America and the pending U.S. commercial launch in conjunction with the contract manufacturing agreement with Accupac and the eMarketing agreement with iMedicor;

3.) to fund further clinical development and new studies for thiarabine and ProLindac.

Click here to visit the ProActive News Room landing page for Access, which includes a compilation of digital media coverage links, report downloads, news feeds, and recent CEO video interview conducted by OneMedPlace.com, including a link to the SEC filing from today.

On 10/27/09, BioSphere Medical (NASDAQ: BSMD) announced the submission to the FDA of an Investigational Device Exemption (IDE) application for a clinical trial for the use of BioSphere's QuadraSphere Microsphere product (QuadraSphere) to deliver the chemotherapeutic agent doxorubicin for the treatment of primary liver cancer. Provided that the FDA accepts the planned clinical protocol, the Company plans to begin enrolling patients into the study within 60 days of FDA approval. The proposed investigation will be a prospective, randomized, double-blinded clinical trial conducted at approximately 15 sites in the U.S., European Union and Brazil.

The clinical trial will focus on treating patients with advanced hepatocellular carcinoma (HCC), also known as primary liver cancer, and will compare QuadraSphere with doxorubicin against conventional transarterial chemoembolization (cTACE) with doxorubicin. BioSphere anticipates that patient enrollment will take approximately 12 months, and that it will file a premarket approval application (PMA) with the FDA approximately 12 months after the final patient is enrolled. The Company expects to fund trial costs from current working capital and cash flow from operations.

On 10/27/09, CryoLife (NYSE: CRY) announced that the FDA has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam Surgical Matrix protein hydro-gel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemo-static agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.

CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial. CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Upon successful completion of the feasibility study, and subsequent FDA and DoD approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study will be conducted. It is currently anticipated that the pivotal investigation will enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.

On 10/27/09, NeoPharm (OTC: NEOL.PK) announced that it submitted a Phase 2 protocol to the FDA for LE-DT for locally advanced or metastatic pancreatic cancer patients. If the study is approved, NeoPharm expects to enroll 40 patients in the Phase 2 trial at 3-4 locations in the U.S. and Europe. NeoPharm has completed enrollment in a multi-center Phase 1 clinical trial for LE-DT (Liposomal Encapsulated Docetaxel) (a liposomal delivery form of Taxotere) for the treatment of patients with metastatic solid tumors and expects to release preliminary findings for the Phase 1 LE-DT study during 4Q09.

Based upon the preliminary results from its Phase I trial for LE-DT for the treatment of patients with metastatic solid tumors, the Company is planning a Phase 2 study of LE-DT in hormone refractory metastatic prostate cancer patients. This open-label, Phase 2 study will be designed to determine the antitumor effect as defined by the serum Prostate Specific Antigen (PSA) levels, disease response, progression free survival, and quality of life in patients with metastatic prostate cancer. NeoPharm is also developing a two-arm protocol, subject to regulatory approval, for advanced pancreatic cancer patients to compare the clinical effectiveness of LE-DT against 5FU or Xeloda.

Disclosure: Long ACCP.OB

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) announced it is scheduled to present at the Oppenheimer 20th Annual Healthcare Conference being held at the Waldorf-Astoria Hotel in New York City, New York.

 

PolyMedix, Inc. (OTC:PYMX), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders, has completed a second successful clinical study of its anticoagulant reversing agent, PMX-60056.

 

Ligand Pharmaceuticals Inc., (NASDAQ:LGND) and Metabasis Therapeutics, Inc. (NASDAQ:MBRX) announced they have entered into a definitive merger agreement under which Ligand will acquire all of the outstanding shares of Metabasis.

 

Geron Corporation (NASDAQ:GERN) will announce its financial results for the 2009 third quarter on Thursday, October 29, 2009, after the closing of the equity market.

 

Life Technologies Corporation (NASDAQ:LIFE) announced results for its third quarter ended September 30, 2009.

 

BioSphere Medical, Inc. (NASDAQ:BSMD) – the leader in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy –announced the submission to the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) application for a clinical trial for the use of BioSphere’s QuadraSphere® Microsphere product (QuadraSphere) to deliver the chemotherapeutic agent doxorubicin for the treatment of primary liver cancer.

 

International Stem Cell Corporation (OTC:ISCO) and Reproductive Medicine Associates of New York (RMA of New York) have show immature, unfertilized human eggs can be used to create “parthenotes” from which human parthenogenetic stem cell lines may be derived.

 

Curis, Inc. (NASDAQ:CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, announced the Company will be presenting at the Oppenheimer 20th Annual Healthcare Conference at 3:55 p.m. EST on November 3, 2009, at the Waldorf Astoria in New York City.

 

Helicos BioSciences Corporation (NASDAQ:HLCS) announced its operational, technical and scientific highlights for the quarter ended September 30, 2009.

 

PolyMedix, Inc. (OTC:PYMX), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders, has completed a second successful clinical study of its anticoagulant reversing agent, PMX-60056.

 

ImmunoCellular Therapeutics, Ltd. (OTC: IMUC), a biotechnology company which is focused on the development of novel immune-based cancer therapies, announced additional data from its Phase I clinical trial evaluating ICT-107, the Company’s dendritic-cell based cancer vaccine product candidate for the treatment of glioblastoma multiforme (GBM).

 

Columbia Laboratories, Inc. (Nasdaq: CBRX) announced Robert S. Mills, president and chief executive officer of Columbia Laboratories, Inc. will present at the upcoming Oppenheimer 20th Annual Healthcare Conference.

 

Alkermes, Inc. (NASDAQ: ALKS) announced the initiation of a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the opioid agonist effects on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC).

 

POZEN Inc. (NASDAQ: POZN) announced the results of a Phase I study that showed a novel, investigational combination of enteric-coated aspirin (EC-ASA) an immediate-release omeprazole known as PA65020, is associated with a significantly decreased risk of GI mucosal damage compared to analgesic doses (650 mg twice daily) of over-the-counter enteric-coated aspirin (EC-ASA) in healthy adults treated for one month.

 

NeoPharm, Inc. (OTC:NEOL) announced it has submitted a Phase II protocol o the FDA for the study of liposome entrapped docetaxel (LE-DT), novel, proprietary liposomal delivery system of docetaxel, the active ingredient of Taxotere®, for locally advanced or metastatic pancreatic cancer patients.

 

OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) announced OSI Management will present at the Oppenheimer Healthcare Conference in New York, NY on Tuesday, November 3, 2009 at 3:20pm (Eastern Time) and will provide an overview on the Company’s product portfolio and business developments.

 

Manhattan Scientifics (OTCBB: MHTX) and Senior Scientific, LLC announced they have begun cooperative work to commercialize Senior Scientific’s nano medicine cancer detection technology.

 

Inhibitex, Inc. (NASDAQ: INHX) announced it would host a conference call on Friday, November 6, 2009 at 9:00 a.m. EDT to review the Company’s financial results for the third quarter ended September 30, 2009 and provide an update on recent corporate developments.

 

A study published this month in the journal Tissue Antigens reports that researchers at Roche Molecular Systems (OTC:RHHBY) in Pleasanton, CA have used high-throughput sequencing technology from 454 Life Sciences, a Roche Company, to carry out high-resolution human leukocyte antigen (HLA) genotyping in research samples.

 

Revolutions Medical Corporation (OTCBB:RMCP), producers of the RevVac safety syringe, RevColor, RevDisplay and Rev3D MRI Technology, announced CEO Ron Wheet has been featured in the popular AllPennyStocks.com Spotlight series, produced by TheNewsWire.ca.

 

Rockwell Medical (NASDAQ:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that it has unveiled a new corporate identity consisting of a new logo, Company name and website.

 

Unilife Medical Solutions (OTC:UNIFF) announced it has commenced the filing of international trademarks for Unifill™, which will become the market brand for its portfolio of ready-to-fill safety syringes.

 

Orexigen® Therapeutics, Inc. (Nasdaq:OREX) announced results from new intent to treat (ITT) analyses from the COR-I and COR-II Phase 3 trial of Contrave® (naltrexone SR/bupropion SR), the first of two late stage Orexigen candidates for the treatment of obesity.

 

Cytori Therapeutics, Inc., (NASDAQ:CYTX) will present and provide a webcast of its corporate presentation at the 2009 BIOCOM Investor Conference at 1:00 PM PDT on Tuesday, October 27, 2009.

 

King Pharmaceuticals, Inc. (NYSE:KG) announced it has licensed from Merck Santé S.A.S., an affiliate of Merck KGaA, Darmstadt, Germany, the exclusive rights to market and sell CYANOKIT® 5 g (hydroxocobalamin for injection) ANTIDOTE in the U.S. CYANOKIT® is indicated for the treatment of known or suspected cyanide poisoning, typically caused by smoke inhalation from fires.

 

McKesson Corporation (NYSE:MCK) reported revenues for the second quarter ended September 30, 2009 were $27.1 billion compared to $26.6 billion a year ago.

 

Please note a change to the Merge Healthcare Inc., (NASDAQ:MRGE) third quarter 2009 earnings call. The call, which was previously scheduled for 4:15 PM EDT on Thursday, October 29, 2009, will now be held at 9:00 AM EDT.

 

PPD, Inc. (Nasdaq:PPDI) reported its financial and operating results for the third quarter ended September 30, 2009.

 

Total Nutraceutical Solutions, Inc. (OTC:TNUS), announced the company has formulated and will launch a unique natural whole food mushroom-based Vitamin D supplement.

 

Osteologix, Inc. (OTC:OLGX) announced Philip J. Young, President and CEO of Osteologix, will present a corporate overview and update at the 8th Annual Bio Investor Forum being held this week at the Palace Hotel in San Francisco, California.

 

3SBio Inc. (Nasdaq:SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, announced it will release financial results for the third quarter ended September 30, 2009 after the US market closes on Thursday, November 12, 2009.

 

 

TomoTherapy Inc., (NASDAQ:TOMO) announced four recipients of grants from the first round of its 2009-2010 TomoTherapy® Clinical Investigation Partnership Program.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

Array BioPharma Inc. (Nasdaq:ARRY) will report financial results for the first quarter of fiscal 2010 on Monday, November 2, 2009, and will hold a conference call on Tuesday, November 3, 2009 at 9:00 a.m. eastern time to discuss these results.

Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced Dr. Leonard Bell, Chief Executive Officer of Alexion Pharmaceuticals, will present at the 20th Annual Healthcare Conference in New York City at 3:55 p.m. ET on Wednesday, November 4, 2009.

Clinical Data, Inc. (NASDAQ:CLDA) announced it has raised gross proceeds of approximately $47.4 million through the public offering of 2,750,000 newly issued shares of its common stock at a price of $17.25 per share.

Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) announced it will release its 2009 third quarter financial results after the market closes on Thursday, November 5, 2009.

SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) announced a corporate restructuring will reduce its U.S.-based workforce by approximately 17%, primarily in research and development.

Safeguard Scientifics, Inc. (NYSE:SFE), a holding company builds value in growth-stage life sciences and technology companies, announced it led a $17.4 million Series B financing round for Quinnova Pharmaceuticals, Inc., with participation from existing investors Thomas, McNerney & Partners and H.I.G. BioVentures.

A.P. Pharma (Nasdaq:APPA), a specialty pharmaceutical company, announced on October 26, 2009, the Company received notice the Nasdaq Listing Qualifications Panel (Panel) has granted the Company’s request to transfer the listing of the Company’s common stock from The Nasdaq Global Market to The Nasdaq Capital Market, which will take effect with the opening of the market on Wednesday, October 28, 2009.

CardioNet, Inc. (NASDAQ:BEAT) announced the U.S. Patent and Trademark office has granted patent number 7,587,237 (“Biological Signal Management”) to CardioNet.

Neoprobe Corporation (OTC:NEOP), a diversified developer of innovative oncology surgical and diagnostic products, announced it would report its financial results for the third quarter of 2009 on Monday, November 2, 2009 after the close of the financial markets.

Alcon, Inc. (NYSE:ACL) reported global sales rose 5.9 percent to $1,614 million for the third quarter of 2009, or a 9.0 percent increase excluding the impact of foreign exchange fluctuations.

Antares Pharma, Inc. (NYSE:AIS) announced Dr. Paul K Wotton, Ph.D., President and Chief Executive Officer, will present at the 20th Annual Oppenheimer Healthcare Conference on Tuesday, November 3, 2009 at 4:30 pm ET (Eastern Time).

Nektar Therapeutics (Nasdaq:NKTR) announced it has completed enrollment ahead of schedule in its Phase 2 clinical study of NKTR-102 in platinum-resistant ovarian cancer.NKTR-102 is Nektar's investigational proprietary compound currently being evaluated in Phase 2 clinical development in ovarian, breast and colorectal cancers.

Arrayit Corporation (OTC:ARYC) announced the sale of a system to the Center of Excellence for Nucleic Acid-Based Technologies (CENAT) in Poznan, Poland.

Enzon Pharmaceuticals, Inc. (NASDAQ:ENZN) announced it will report its financial results for the quarter ended September 30, 2009, on Tuesday, November 3, 2009 at approximately 8:00 am Eastern Time (ET).

Advaxis, Inc., (OTC:ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, completed a second Company-run debt financing, as of October 26, 2009.

BioSphere Medical, Inc. (NASDAQ:BSMD) – the pioneer in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy –reported financial results for the three and nine months ended September 30, 2009.

Phase Forward Incorporated (NASDAQ:PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced it will be hosting an analyst session on Wednesday, November 4, 2009, in conjunction with the Phase Forward 8th Annual International Users Conference in Boston, MA.

SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced it will host a live webcast of its fourth quarter and fiscal year 2009 conference call on Wednesday, November 4, at 4:00 p.m. CT.

Genta Incorporated (OTC:GETA) announced the Company will host a conference call and live audio webcast to review top-line results of its Phase 3 trial of Genasense® in patients with advanced melanoma.

UnitedHealth Group (NYSE:UNH) announced the company has appointed both Christopher J. Walsh and Mitchell Zamoff to the position of executive vice president and general counsel, effective immediately.

CNS Response, Inc. (OTC:CNSO) announced that the company will present top-line results from its multi-site clinical trial next week at the U.S. Psychiatric and Mental Health Congress.

Bio Solutions Corp. (OTC:BISU) announced the introduction of their new website:  http://www.bio-solutionscorp.com".

Stock Symbols: BSMD,CDNS,CNS,CNW,CRUS,CYBE,FFIV,FNF,GDI,IRBT,KAI,LSI,MCRI,MOH,MRCY,NTRI,PHM,ROL,RYL,SCSS,SKX,TLGD,TSCO,BIDU,CMG,EQIX,NARA,OMTR,OSIP,SJW,PRE,BCR,CVGI,WIRE[More...]

Headquartered in Amsterdam, The Netherlands, Koninklijke Philips Electronics N.V. (PHG) is one of the world's largest electronics companies and the biggest in Europe, with sales of 27 billion in 2007 and 12.4 billion in 1H08. The company has worked to improve its cost structure, as its EBITA margins remained flat along with modest revenue performance despite the weaker-than-expected dollar. Based on these results, we are maintaining our revenue estimates for 2008. We continue to rate the shares of PHG a Hold with a price target of $28.50 per share over the next six months. This amounts to between 6.7x-6.9x our new 2008 EPS estimate of $4.19. Udayan Mukherjee contributed to this report. Read[More...]