The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.
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.
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