Protox Therapeutics (TSX: PRX.TO) (OTC: PTXRF.PK) applies genetic engineering techniques to create innovative, targeted protein-based therapeutics which are focused on prostate conditions and cancer. The Company’s clinical-stage pipeline is based on the PORxin and INxin technology platforms. Lead drugs in clinical development include PRX302 for the treatment of benign prostatic hyperplasia (BPH or enlarged prostate) and localized prostate cancer as well as PRX321 for primary brain cancer (glioblastoma multiforme / GBM and astrocytoma).

PRX302 Poster Presentation at SIU - Nov. 2009: Click on the preceding link for a PDF link to the Company’s poster presentation of detailed 12-month results from a Phase 2 open-label clinical trial that were presented at the 30th World Congress of the Societe Internationale d’Urologie (SIU) in early November. Below is a summary of the poster presentation at SIU 2009, which concluded that PRX302 is a novel and promising, first-in-class, disease modifying agent for the treatment of BPH based on Phase I/II clinical data that has been generated to date.

1.) PRX302 is well tolerated in BPH patients at injection volumes equivalent to up to 30% of prostate size

2.) A volume per deposit of ≥ 1 mL was associated with improved efficacy

3.) International Prostate Symptom Score (IPSS) and Quality of Life scores improved significantly (p<0.01) out to at least 360 days following a single treatment

4.) Patients receiving the optimum dose (≥ 1mL per deposit) in the Phase II study had an average of 12 point improvement in IPSS at day 360 post dosing

5.) 73% of the patients receiving the optimum dose were treatment responders (>30% drop in IPSS)

6.) PRX302 does not adversely impact sexual function and is easy to administer in a 10-15 minute outpatient setting

On 9/8/09, Protox announced that it has completed patient enrollment in a multi-center, double-blinded, placebo-controlled Phase 2b study (TRIUMPH) of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide. TRIUMPH is the third BPH clinical trial of PRX302 conducted by Protox. In addition to being well-tolerated, the previous open-label Phase 2 study reported at the 2009 Annual Meeting of the American Urological Association, showed an 11 point improvement in the International Prostate Symptom Score at the optimal PRX302 dose used in the TRIUMPH study.

PRX302 is the lead drug in the company’s PORxin technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from BPH and prostate cancer. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.

The Company expects to report top-line results from the TRIUMPH study during late 2009 or early 2010. PRX302 represents a potentially new treatment option for BPH and other prostate conditions with blockbuster potential based on $3 billion in annual sales for BPH drugs (e.g. Flomax, Avodart, Proscar) and the 575,000 surgical procedures that are performed each year in the top seven markets worldwide.

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. Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my 22 ProActive HavRx stock indexes. This service will allow investors to create personalized exchange-traded funds (ETFs) and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes.

Disclosure: Long PTXRF.PK

Urocidin is designed to treat non-muscle-invasive bladder cancer, in which the cancer is confined to the surface layers of the bladder.  The experimental drug works by stimulating immune response while promoting anticancer activity.  It is delivered directly into the bladder using a catheter.  Urocidin, which has been granted fast track status by the U.S. Food and Drug Administration,  is currently in Phase III clinical trials.  Bioniche did not disclose the reason for the $6 million payment.

Bladder cancer is one of the most common cancers in the U.S., making the top ten for both men and women. It has the highest recurrence rate of any cancer, meaning that patients must be monitored for life. Approximately 70 percent of bladder cancer patients have the non-muscle-invasive form of the disease at the time of diagnosis. Peplin Limited and Viventia Biotech are two additional companies developing therapeutics for bladder cancer. Peplin Unlimited’s PEP005, a plant-based compound, has shown potential anticancer activity against bladder cancer in preclinical tests. Vicinium by Viventia is undergoing Phase II trials for the treatment of bladder cancer.

The most recent findings came from an FDA pivotal clinical trial of GT’s LightTouch Non Invasive Cervical Cancer detection device. Traditional methods for screening for cervical cancer performed poorly in the study. The human papillomavirus (HPV) test and colposcopy missed 32 percent of cancers and precancers, while biopsy samples overlooked 19 percent. A previous study by the NCI found that 35% of cases were missed, and only 26% of biopsies found significant disease.

LightTouch analyzes wavelengths of light reflected off cervical tissue to diagnose abnormalities. The non-invasive technology is able to detect chemical and structural changes at the cellular level.  LightTouch does not require biopsy samples, and results are given immediately.  GT has received approximately $6 million in grants from the NCI to develop the LightTouch device for the detection of cervical disease.  Over 2,000 women  were enrolled in the pivotal clinical trial.

Companies such as CYTYC Corporation, Matritech, MTM Laboratories AG, Grant Life Sciences, and CytoCore are working to create more accurate diagnostic screenings for cervical cancer, a disease that used to be the leading cause of cancer death for women in the United States. Cervical cancer still kills approximately 4,000 women in the U.S. each year.

Last summer, Gaithersburg, Maryland-based GenVec announced positive data from a Phase II/III clinical trial of TNFerade.  The drug provided a 42.5% reduction in the risk of death when combined with standard treatment, when compared to standard treatment alone.  TNFerade is also being explored as a candidate to treat esophageal cancer, rectal cancer, and head and neck cancer.

More good news for GenVec: The company has signed a $22 million development deal with Science Applications International to develop HIV and flu vaccines.  GenVec will receive approximately $2.6 million over the next year.

 The FDA grants orphan drug designation to drugs that may be significantly more effective than currently existing treatments, and target conditions that affect less than 200,000 U.S. patients per year.  Upon approval, drugs granted orphan status enjoy seven years of marketing exclusivity in the United States.  The National Cancer Institute estimates that over 42,000 U.S. patients will be diagnosed with pancreatic cancer in 2009.  There are no early symptoms of pancreatic cancer, so it is particularly challenging to diagnose in its beginning stages.  The disease is difficult to control once it has spread.  Pancreatic cancer is typically treated with surgery, chemotherapy, or radiation therapy, sometimes in combination.

Some other companies developing treatments for pancreatic cancer are Nanobiotix, Inovio Biomedical Corporation, AmpliMed Corporation, Celldex Therapeutics, and Ganymed Pharmaceuticals.

According to Ann M. Veneman, UNICEF Executive Director, pneumonia kills over 4,000 children under age 5 every day. The new plan could save more than 5 million children over 6 years. The plan takes a three-pronged approach: promoting a healthy environment through practices such as handwashing, preventing illness through vaccines, and providing young pneumonia patients with proper care and medication. The Global Task Force on Pneumonia, which both WHO and UNICEF belong to, plans to coordinate implementation of the new strategy, particularly in countries that are hardest hit by pneumonia.

Pneumonia is typically treated with antibiotics, but some biopharmaceutical companies are taking novel approaches to treating various forms of pneumonia. Massachusetts-based Enanta Pharmaceuticals is developing EDP-420, a small molecule drug that is part of a new class of macrolide antibiotics called Bicyclolides. Enanta’s drug are designed to overcome bacterial resistance in diseases such as pneumonia.  A novel anti-infective compound from San Jose, Calif.-based Aridis Pharmaceuticals may be effective against antibiotic-resistant, hospital acquired pneumonia. Immtech International of New York City is developing a new class of oral drugs to treat infectious diseases, including pneumonia.

Micromet

In addition to the $12 million payment, Micromet could receive up to $241 million upon reaching certain developmental and regulatory milestones. The company could also earn up to $224 million in royalties and performance-based milestone payments.  BiTE (short for bi-specific T-cell engagers) antibodies have been shown to bind T-cells to tumor cells, inducing a self-destruction process that leads to cell death.   

According to a recent article by Mark Reisenauer, SVP and Chief Commercial Officer of Micromet, T-cells are the most potent killing cells found in the immune system due to their ability to proliferate and kill targeted cells serially. Micromet’s BiTE antibody blinatumomab is currently in Phase I clinical trials for non-Hodgkins lymphoma. Other companies developing T-cell-based therapeutics include Tolera Therapeutics, Scancell, and Immutep.

Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) is an emerging medical device manufacturer with business segments that include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing of medical devices.

More than two billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife’s safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000). Key differentiating features of Unilife’s fully-integrated (within the barrel of the syringe) safety syringes include the following:

1.) a passive needle retraction system that is activated inside the body

2.) healthcare providers / shot administrators control the speed of needle retraction

3.) auto-disabling prevents re-use or tampering with used syringes

The market opportunity for prefilled syringes includes 50 drugs (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including an estimated 3 billion prefilled syringes in use by 2012. Unilife has a distinct advantage with a disruptive technology since there are currently no prefilled syringes to deliver medications with fully-integrated safety features so pharmaceutical companies must add these features - which adds to production / shipping costs and increases the overall packaging size by up to 60%, resulting in both waste disposal and marketing issues.

In mid-August, Unilife announced that it has commenced U.S. production of the Unitract^TM 1mL Insulin Syringe at its FDA-registered manufacturing facility in Pennsylvania. The Company’s automated assembly system is now rated at up to 90% of efficiency and Unilife will continue to work towards achieving the optimum productivity rate for this assembly system of about 40 million units per year. Unilife will now begin to build inventory to fulfill current and anticipated orders for its Unitract 1mL Syringes, which has already received key regulatory certifications for use in major markets such as the U.S. (FDA), Canada, Europe (CE Mark), and Australia.

Commercial release of the Unitract 1mL Syringes is expected to occur during 4Q09 once product aging studies have been completed and Unilife will promote the products at key industry events in the U.S. and Europe. Unilife is currently in discussions with a number of global pharmaceutical and healthcare companies that are interested in the Unitract 1mL Syringes. The Company also recently announced a pair of upcoming presentations at pharmaceutical trade shows in Europe to showcase its safety syringe technology and products.

The Company’s strategic partner for exclusive manufacturing and distribution of sharps safety products is Shanghai Kindly Enterprise Development Group (KDL). This facility currently produces Unitract 1mL syringes and MedPro blood collection safety devices using semi-automated assembly systems developed and qualified by Unilife. KDL is the second largest medical device manufacturer in China and has two-thirds market share of the Chinese needle market, manufacturing over 5 billion needles and 600 million syringes per year. In addition, Unilife has a development agreement with PA-based West Pharmaceutical Services (NYSE:WST) for the provision of specialist components such as seals for Unitract products.

The key strategic business partner for Unilife is Sanofi-Aventis (NYSE:SNY), which is the largest buyer of pre-filled syringes in the world for injectable products such as the blood thinner Lovenox and influenza vaccines such as Fluzone marketed by the Company (Griffin Securities estimates that SNY purchases 40% of all pre-filled syringes on a global basis). Last July, Unilife and SNY agreed to a five-year exclusive licensing agreement for the Unilife Pre-Filled syringe. SNY is paying US$38M for the right to negotiate purchase of the RTFS (ready-to-fill syringe), consisting of fees and milestone-based industrialization payments with ongoing negotiations for exclusivity agreements by therapeutic class (e.g. blood thinners, vaccines, etc.).

The industrialization agreement with SNY for Unilife Ready-to-Fill Syringe (RTFS) announced mid-year allows Unilife to move forward with discussions that include other potential customers that are interested in the Company’s prefilled syringes (with an additional agreement expected in early 2010). This key partnership with SNY provides Unilife with the necessary capital to expand its U.S. manufacturing capacity and will provide a major source of demand for the Company’s pre-filled syringes by late 2010 with a production target of 40 million units per year at that time.

The program was originally intended to be completed by the end of 2011, but it is proceeding ahead of schedule so that both parties have agreed to bring its scheduled completion date forward to the end of 2010 (an entire year ahead of schedule). Unilife is scheduled to commence supply of the RTFS by the end of 2010. Initial supply of the RTFS by Unilife will utilize a fully automated assembly system that will have a targeted annual capacity of more than 40 million units. The design of this first line will also be used to develop a higher-volume automated assembly system scheduled to be completed by the end of 2011.

This high-volume automated assembly system is anticipated to have an annual production capacity greater than 100 million units and Unilife has a target production plan for the RTFS of about 400 million units per year beyond 2014. In addition, the centralization of RTFS production activities within Central PA is expected to occur in 2010 and will reduce the Company’s operational costs, further optimize its supply chain activities, and place Unilife in a more favorable international location to supply the RTFS to all of its anticipated customers while leveraging the Company’s strong, mutually beneficial relationship with the PA government due to the generation of high quality jobs in the state.

Earlier this week, Unilife announced this week that it has accepted a $5.2 million offer of assistance from the Commonwealth of Pennsylvania to support the creation of 241 new jobs within York County. The Company’s expansion plans in Central PA include the proposed redomiciliation from Australia to the U.S., obtaining a NASDAQ listing for the stock, and the establishment of a major new global headquarters + manufacturing facility.

Unilife also announced this week that it has commenced the filing of international trademarks for Unifill^TM, which will become the market brand for its portfolio of ready-to-fill safety syringes. The product previously referred to on a pre-commercial basis as the Unilife Ready-to-Fill Syringe (or Unilife Prefilled Syringe) will now be marketed as the Unifill syringe. Unilife has developed the Unifill brand to help the Company effectively market its expanding range of injectable drug delivery products designed for use by pharmaceutical companies.

Last week, Unilife announced that CEO Alan Shortall 479,800 shares of the Company’s stock on the open market at an average price of A$1.026 per share and the CEO has authorized his broker to purchase additional shares that will bring the total number of shares purchased to over 500,000. Mr. Shortall commented that he elected to purchase the shares in the open market rather than participate in the Company’s recently announced private placement (conducted at a 7.7% discount to the market price at the time) as a sign of confidence to shareholders

In early October, Unilife announced an A$42.1M capital raise (consisting of an A$32.1M private placement to institutional investors + A$10M fully underwritten share purchase plan to existing, eligible shareholders at the same price of A$0.85 per share) to accelerate the expansion of its operational capabilities, production facilities, and equipment requirements in the U.S., in addition to completing the industrialization of the Unilife Ready-to-Fill Syringe. Unilife also plans to expedite the commercialization of additional pipeline products with other interested major pharmaceutical companies with whom the Company is currently in discussions. Finally, the proceeds of the capital raise will ensure adequate cash reserves leading to the redomiciliation in the U.S. and planned NASDAQ listing for the stock.

The Company announced that it received significant interest in recent months from both U.S. / Australian investors and other industry stakeholders for its strategic and operational strategies and the Board determined that it was in the best interests of shareholders to act upon this strong interest prior to its anticipated NASDAQ listing to ensure the Company has sufficient cash reserves to support and accelerate significant business expansion activities which it expects to undertake within the United States.

Since I first wrote about Unilife in early April, the US-listed Pink Sheet ADR (UNIFF.PK) has experienced an exponential rise in both share price (from below 25 cents to the one dollar range) and trading volume as investors recognize the significant potential of the Company’s niche strategy focused on safety syringes. The bullish sentiment by investors for Unilife is warranted given its disruptive safety syringe technology, relocation plans to the U.S. / NASDAQ stock listing next year, partnership with Sanofi, recent capital raise, and an additional deal expected next year.

Click here for the ProActive News Room landing page for Unilife, which includes a compilation of digital media coverage links for the Company and several recent reports and presentations, including those outlined below.

Unilife Medical (OTC: UNIFF.PK): Griffin Securities 8/19/09

Unilife Medical (OTC: UNIFF.PK): Sept. 2009 Presentation

Unilife Medical (OTC: UNIFF.PK): CCZ Equities 10/13/09

Disclosure: No positions

The purchase is a positive development for La Jolla, Calif.-based Metabasis, which announced in June that it might have to cease operations if it did not raise additional capital. Metabasis cut 30 percent of its staff last fall, then further reduced its workforce from 52 to 7 employees in May.  The company reported an $8.2 million loss in the first quarter of 2009.  Shares in Metabasis were trading at 44 cents this morning.

Metabasis is the developer of the HepDirect targeted drug delivery platform for liver diseases.  Last year, the company entered into a collaborative agreement with Roche to develop hepatitis C treatments using the HepDirect system.  Metabasis also develops small molecule drugs for Type 2 diabetes, high cholesterol, hepatitis B, and liver cancer. San Diego-based Ligand has agreed to spend $8 million on research and development programs for Metabasis. Ligand is partnered with a number of large pharmaceutical companies, including Wyeth and Pfizer, on a variety of drug development projects. Ligand’s newest product, Avinza, targets moderate to severe pain.

On 7/15/09, Cadence Pharma (NASDAQ: CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency. The Company’s 505(b)(2) NDA for Acetavance includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of endotoxin-induced fever.

The NDA is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 pediatric patients, from premature neonates to adolescents, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside of the U.S.

On 8/4/09, Nuvo Research (TSX: NRI.TO) (OTC: NRIFF.PK) announced that the FDA issued a new PDUFA action date for Pennsaid (diclofenac sodium) topical solution 1.5% of 11/4/09. During the review process, Nuvo provided the FDA with supplemental information, which the Agency determined to be a major amendment to the Pennsaid New Drug Application (NDA). As a result, the FDA has extended its action date by three months to provide time for a full review of the submission.

On 6/16/09, Nuvo announced a deal with Covidien (NYSE:COV) which granted exclusive rights to market and sell Pennsaid, and its follow-on product, Pennsaid Plus, in the U.S. Pennsaid and Pennsaid Plus are Nuvo’s topical non-steroidal anti-inflammatory drug (NSAID) candidates that deliver diclofenac through the skin directly to the site of pain. Nuvo receives an up-front, non-refundable payment of US$10M and is also eligible to receive a US$15M milestone payment on Pennsaid’s approval by the FDA, which will increase to US$20M if certain labeling criteria are agreed to by the FDA.

In addition, Nuvo will receive royalties on net U.S. sales of Pennsaid and Pennsaid Plus and is also eligible to receive additional escalating sales milestone payments for the products totaling up to US$100M. COV assumes responsibility for all future development activities and expenses for Pennsaid Plus, including two Phase 3 clinical trials that are expected to begin in 2010.

On 10/20/09, Human Genome Sciences (NASDAQ: HGSI) and GlaxoSmithKline (NYSE: GSK) announced the full presentation of results from BLISS-52, the first of two pivotal Phase 3 trials of BENLYSTA (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). The data demonstrate that, in BLISS-52, belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care.

Study results also show that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. HGSI stated that these data were statistically significant and were strongly supported across multiple measures of clinical effect and multiple time-points and included a greater percentage of patients receiving BENLYSTA that were able to reduce their use of steroids. Belimumab is an experimental drug and the first in a new class of drugs called BLyS-specific inhibitors being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.

Results from BLISS-76, the second Phase 3 trial of belimumab, will be announced on 11/2/09. Assuming the results from BLISS-76 are positive, HGS and GSK plan to submit marketing applications in the United States, Europe and other regions during 1H10.

On 8/5/09, NeurogesX (NASDAQ: NGSX) announced that the FDA extended the PDUFA action date by three months to 11/16/09 for the Company’s pending new drug application (NDA) for Qutenza which is seeking approval to manage pain associated with post-herpetic neuralgia (PHN). The extension resulted from the Company’s recent submission of data requested by the agency late in the review cycle, which the FDA has classified as a major NDA amendment. Submission of a major amendment within three months of the PDUFA date can trigger a three-month extension to the original review timeline.

The information submitted in July includes a report from the Company’s recently completed C123 Study, which was performed at the request of the FDA. On 7/24/09, NGSX announced preliminary results of Study C123, which evaluated Qutenza in patients with PHN following pre-treatment with an FDA approved topical anesthetic. Preliminary results of Study C123 showed the mean duration of patch application was 60.2 minutes, versus a target duration of Qutenza patch application of 60 minutes, and no patients removed the Qutenza patch prematurely.

NGSX received approval on 5/21/09 to market Qutenza in the EU. Qutenza is a skin patch that is designed to locally deliver a high-concentration (8%) of the active substance capsaicin to provide sustained relief from peripheral nerve pain.

On 9/29/09, Cerus Corp. (NASDAQ:CERS) announced that it will present the proposed design for a U.S. Phase III clinical trial of the INTERCEPT Blood System for platelets at the upcoming November meeting of the FDA’s Blood Products Advisory Committee (BPAC). The Committee meeting is open to the public and discussion of the INTERCEPT trial is scheduled to occur the afternoon of November 16.

“The proposed Phase III clinical trial design that we’ll discuss with the Advisory Committee was created through close collaboration between Cerus and the FDA Office of Blood Review,” said Carol Moore, Cerus’ vice president of regulatory affairs, quality and clinical affairs. “We look forward to presenting the result of this joint effort to BPAC, and hearing their views on this significant step forward toward defining a US approval pathway for INTERCEPT pathogen inactivated platelets.”

Cerus has previously announced that an additional Phase III platelet trial was anticipated to be necessary for US approval. The INTERCEPT platelet system was granted CE mark registration in 2002, and subsequently received additional European regulatory approvals in France (Afssaps), Switzerland (Swissmedic), Germany (Paul Ehrlich Institute marketing authorization for the German Red Cross).

XenoPort (NASDAQ: XNPT) has a pending NDA for Solzira (gabapentin enacarbil) Extended Release Tablets seeking approval for the treatment of moderate to severe restless leg syndrome, which was accepted for review by the FDA on 3/16/09 and includes collaboration agreements with Glaxo and Astellas Pharma with an expected FDA decision on 11/9/09. Solzira is a new chemical entity that was developed by XNPT to improve upon the absorption characteristics of gabapentin (in a once-daily formulation) through specific transport mechanisms in the GI tract.

On 10/19/09, BioElectronics (OTC: BIEL.PK) announced the initial results from the pilot section of its ongoing acetaminophen comparison study. The study, which is expected to be complete during early November, compares the effects of ActiPatch Therapy to acetaminophen in the form of Extra Strength Tylenon for the treatment of delayed onset muscle soreness (DOMS).”Thus far, results from the pilot section of this study seem to be highly statistically significant with the ActiPatch group scoring its average level of muscle soreness and discomfort at much lower levels compared to either the control group or the acetaminophen treatment group,” commented principal investigator Sheena Kong, M.D.

The study, which is Institutional Review Board (IRB) supervised, is currently ongoing with full study results expected during early November 2009. On 8/24/09, BioElectronics announced it would sponsor a clinical study comparing the effects of its ActiPatch Therapy to Tylenol for the treatment of muscle pain and soreness. The study is conducted in two locations utilizing three groups of subjects, including: 1) a control group, 2) a group that will utilize ActiPatch Therapy, and 3) a group that will be given acetaminophen in the form of Tylenol.

Protox Therapeutics (TSX: PRX.TO) (OTC: PTXRF.PK) applies genetic engineering techniques to create innovative, targeted protein-based therapeutics which are focused on prostate conditions and cancer. PRX302 is a genetically engineered version of a protein (proaerolysin) that is secreted by a specific type of bacteria (Aeromonas hydrophilia).

PRX302 is the Company’s lead PORxin drug, which are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 is activated by prostate-specific antigen (PSA), an enzyme that is over-produced in patients suffering from BPH and prostate cancer. PRX302 represents a potentially new treatment option for BPH and other prostate conditions with blockbuster potential based on $3 billion in annual sales for BPH drugs (e.g. Flomax, Avodart, Proscar) and the 575,000 surgical procedures that are performed each year in the top seven markets worldwide.

This approach avoids side effects and other negative factors of drug therapy for BPH, including (1) the need for lifetime therapy on a daily basis; (2) the potential for sexual dysfunction; (3) fatigue / dizziness / low blood pressure; (4) the potential for drug interactions. In contrast to drug therapy and surgical procedures, PRX302 is minimally invasive and administered as a single treatment that involves a 10-minute procedure that can be conducted in a doctor’s office with no catheterization required. Advantages for physicians include no capital investment, ultrasound-guided delivery, and a short procedure time.

On 9/10/09, Protox announced positive 12-month data from its open-label Phase 2 study of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH). The study results indicate that those patients who received an optimal dose of PRX302 continued to demonstrate significant symptomatic relief at 12 months following a single treatment. The International Prostate Symptom Score (IPSS) is a validated accepted clinical end-point used to assess the treatment benefit in BPH clinical studies. This index is measured on a 0-35 scale with 0 defined as having no problems and 35 defined as the high end of severe symptoms.

In this Phase 2 open-label volume optimization study, 13 of the 18 patients received the optimum PRX302 dosing of (greater than)-1mL per deposit. A total of 11 of the 13 patients were evaluable at 12-months and continued to show a statistically significant and sustained improvement in IPSS of 12.1 points (which is in a similar range to surgical procedures and much better than drug therapy, which results in an improvement of about 4-7 points) representing a 55% improvement when compared to screening.

No safety issues were identified in this study, as increasing volumes of PRX302 were seen to be well tolerated. No PRX302 related serious adverse events or Grade 3 or greater adverse events have been reported to date. The PRX302 related adverse events were mild to moderate, transient in nature (resolved within days) and localized to the urinary tract. In addition, no sexual dysfunction has been reported in any of the subjects dosed to date. Detailed 12-month results from this Phase 2 open-label clinical trial will be presented at the 30th World Congress of the Societe Internationale d’Urologie from November 1-5, 2009.

On 9/8/09, Protox announced that it has completed patient enrollment in a multi-center, double-blinded, placebo-controlled Phase 2b study (TRIUMPH) of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide. The Company recently provided guidance for reporting top-line results from the TRIUMPH study during 4Q09.

Access Pharma (OTC: ACCP.OB) provided an update in mid-October on the clinical and commercial status of MuGard, which has already been launched by its partner, SpePharm, in five European countries for the prevention and treatment of oral mucositis. SpePharm is currently collecting information from approximately 1,500-2,000 patients as part of a comprehensive set of post-marketing / seeding studies being conducted in the UK, Germany, and Italy.

SpePharm anticipates that data from these studies will be made on a rolling basis throughout 4Q09-1Q10 while the commercial launch of MuGard in France and other European countries will continue over the next 12-18 months. Initial patient and clinician feedback has been very positive, according to SpePharm’s President / CEO, Jean-Francois Labbe, which validates interim data released from the UK study that demonstrated no cases of oral mucositis in 140 patients who received MuGard while undergoing treatment for head and neck cancer.

The number of patients being evaluated in the European post-marketing studies is more than originally anticipated and Access will be able to utilize the data in North America for both marketing and licensing negotiations. A steady stream of data is expected to occur over the next 3-6 months now given the larger patient population being analyzed and compiled by SpePharm. I have confirmed with Access President / CEO, Jeffrey Davis, that data is expected in a matter of weeks with the final UK results expected first, followed by data from Germany.

On 10/7/09, NeoStem (AMEX: NBS) announced that the SEC declared effective its Registration Statement on Form S-4 filed with the Commission, which is being used in connection with the proposed acquisition of China Biopharma (which owns a 51% controlling interest in Suzhou Erye). The acquisition is subject to customary closing conditions - including approval by the shareholders of each company at upcoming meetings scheduled on 10/29/09. NeoStem is an innovator and leader in the pre-disease collection, processing and long-term storage of adult stem cells for the general population to use in future medical applications that is expanding into research, medical tourism, and China for the commercialization of anti-aging / cosmetic medicine and other stem cell technologies.

1.) NeoStem (U.S.) includes an exclusive worldwide license to VSELs, a strong IP sourcing network for innovative stem cell / pharmaceutical products and AMEX listing for the stock in addition to its position in the domestic market as a leading adult stem cell banking network.

2.) Suzhou Erye is a high-growth generic pharmaceutical manufacturer in China with a strong core business / profitable revenue base amidst booming demand and growth in the Chinese market.

3.) NeoStem (China) has strong support from the Chinese government for commercialization of cosmetic / regenerative medicine applications which will also expedite the process of U.S. development as the Company becomes a vertically integrated stem cell operation in a permissive regulatory environment that incldues strong government support.

Check out NeoStem’s News Room Page for a compilation of links, videos, articles, news feeds, and more for the Company and click here for my overview article outlining the three-part post-merger strategy. Other companies in my stock coverage universe with news room landing pages include Access Pharma and Protox Therapeutics.

MikeHavRx.com has relocated / forwarded to my new home at http://www.proactivenewsroom.com/ with 20 stock indexes, stock research landing pages, and more. . .Subscribe by email or feed reader at the Feedburner site for my ProActive News Room blog at http://feeds.feedburner.com/ProActiveNR. Also, I will continue to manage the FDA Calendar service at BioMedReports.com and contribute articles, reports, etc. as previously.

Disclosure: Long ACCP.OB, PTXRF.PK

Companies presenting at the 2010 OneMedForum will receive a 20 percent discount on all conference-related releases distributed via Marketwire to the National, New York Metro, or Financial Hot Spot News lines. These services will allow business to benefit from reaching financial terminals as well as key local print, radio, broadcast, and online media.

“Our mission at OneMedPlace is to leverage the global communication reach of the Internet to foster dialogue between emerging healthcare companies and the resources that contribute to their success, said Chelli Miller, Director of Client Services at OneMedPlace. “Our belief is that Marketwire’s suite of products and services will help us continue to achieve this mission, thereby generating exposure for our member companies in every corner of the world.”

“Marketwire is pleased to sponsor the OneMedPlace Forum 2010,” said Marketwire VP of Sales for the Eastern Region Sylvie Harton. “This forum was created to showcase promising emerging companies and industry experts and we are happy to help increase their exposure.”

About OneMedPlace

OneMedPlace is a virtual community of healthcare and life science companies. It has, for the first time, put in place the innovations that will shape the future of health and medicine — emerging companies and technologies seeking capital, distribution, visibility, and investors and strategic partners looking for health and medical innovations to invest in, acquire, license, distribute, purchase or utilize.

About Marketwire

The only fully integrated North America-based global newswire, Marketwire, Inc. is a full-service partner to IR, PR and MarCom professionals seeking top-tier press release distribution, media management, multimedia and monitoring solutions. Marketwire’s customer-centric corporate philosophy focuses on being the best by infusing every aspect of its business with the following core attributes: precision, adaptability, innovation and simplicity.

Marketwire delivers its clients’ news to the world’s media and financial communities, fulfilling disclosure requirements in North America in compliance with the Securities and Exchange Commission (SEC) and the Toronto Stock Exchange (TSX), and serving as Primary Information Provider (PIP) with the UK’s Financial Services Authority (FSA).

Marketwire distributes the majority of press releases issued by publicly traded companies in Canada and serves more than 11,000 clients worldwide through 20 offices on four continents. For more information, visit us at http://www.marketwire.com/.

View the trailer for the OneMedForum:

Learn+about+the+2010+OneMedForum at OneMedTV.