Bd Biotech Daily Apr 23

Biotech Daily Wednesday April 23, 2008

Daily news on ASX-listed biotechnology companies * ASX UP, BIOTECHS DOWN: CYTOPIA, LIVING CELL UP 11%, SUNSHINE HEART DOWN 22% * TISSUE THERAPIES TORONTO TRIAL 4 MONTHS LATE * USCOM POSTS FIRST CASH FLOW POSITIVE QUARTER * CLINUVEL SAFE, ACTIVE AT A RANGE OF DOSES * ATCOR SAYS RESEARCH BACKS CENTRAL BLOOD PRESSURE * SAFETY MEDICAL TO SUPPLY SA MENTAL HEALTH * VIRALYTICS GRANTED US PATENT FOR COXSACKIE VIUSES * APOLLO HIRES DELOITTE TOUCHE TOHMATSU FOR RESTRUCTURE * GENETIC TECHNOLOGIES LOSES CSO GAINS COO, PEOPLE MANAGER * SUN HUNG KAI TAKES 5% OF ARANA MARKET REPORT The Australian stock market climbed 1.5 percent on Wednesday April 23, 2008 with the All Ordinaries up 83.0 points to 5,711.4 points. Twelve of the Biotech Daily Top 40 stocks were up, 14 fell, six were unchanged and eight were untraded. Cytopia and Living Cell were equal best, up three cents or 11.11 percent to 30 cents, followed by Polartechnics up 8.7 percent to 25 cents and Starpharma up 7.81 percent to 34.5 cents. Cellestis and Clinuvel were up more than six percent; Heartware and Psivida climbed more than four percent; Ventracor was up 3.9 percent; Arana and Cochlear rose more than two percent; with Agenix, CSL and Prana up more than one percent. Sunshine Heart led the falls, down two cents or 22.2 percent to 7.0 cents, followed by Progen down 9.8 percent to $1.61 and Optiscan down 6.67 percent to 21 cents. Avexa and Benitec both fell five percent; Antisense and Sirtex lost more than four percent; Novogen and Tissue Therapies lost more than three percent; with Acrux, Alchemia, Mesoblast and Pharmaxis down more than two percent.

TISSUE THERAPIES Tissue Therapies is yet to begin a Vitrogro would treatment clinical trial in Toronto originally scheduled for December 2007. In September the company said that changes to rules for ethics committees had pushed the trial into the Christmas holiday period and due to the cold weather, it was not likely to begin until January 2008. In a media release entitled “Further positive Vitrogro preclinical results and clinical trial update” the company reported recent safety results and said on the second and third pages that the Toronto trial for the treatment of diabetic, venous and pressure ulcers was “imminent”. Tissue Therapies chief executive officer Dr Steven Mercer said the company had “answered a number of minor queries from Health Canada”. “We are confident that the human trial of Vitrogro for the treatment of skin ulcers will commence imminently,” Dr Mercer said. Dr Mercer said the Health Canada classification of Vitrogro for wound healing was a class IV medical device, not as a pharmaceutical or a lower class device. He said the class IV device classification had the commercial benefits of avoiding the costs and time of a pharmaceutical clinical trial and regulatory approval, while allowing Tissue Therapies to make specific claims about the ability of Vitrogro to accelerate wound healing. This will also allow sales and distribution by traditional devices/wound care companies instead of limiting sales of Vitrogro products only through pharmaceutical companies. Tissue Therapies said a trial in February and March 2008 demonstrated that when Vitrogro was used to treat acute incision wounds, such as donor site or surgical wounds healing was faster with Vitrogro, with complete wound closure (re-epithelialisation) at day eight, compared to day 10 for all other groups; and it appeared by both visual inspection of the wound as well as microscopic examination that Vitrogro reduces inflammation and swelling. The company said this suggested Vitrogro may improve patient comfort and reduce scarring. Tissue Therapies said it was also evident that the healing of acute wounds stimulated by Vitrogro resulted in an excellent cosmetic result, with substantial restoration of normal skin pigmentation. Tissue Therapies fell 0.5 cents or 3.03 percent to 16 cents. USCOM Uscom chairman Robert Phillips says the company’s first positive cash flow quarter is a landmark showing that the business is heading in the right direction. Uscom manufactures the ultra sonic cardiac output monitor which has seen increasing sales to emergency , intensive care and paediatric units as a non-invasive alternative to cardiac cather measurement. The company posted a net operating cash flow for the three months to March 31, 2008 of $2,486, compared to a cash burn of $1.27 million for the nine months to March 31. Mr Phillips said there were no extraordinary items that weren’t in previous quarters and the company had costs under control with increasing revenue from product sales. Uscom was untraded at 18 cents.

CLINUVEL Clinuvel says pharmacokinetic studies confirm the safety of the photoprotective drug CUV1647 at a lower dose as well as at more frequent and repeated higher doses. Clinuvel said two studies (CUV007 and CUV009) were conducted at the Australian Centre for Pharmaceutical Research at the University of Adelaide, under principal investigator Associate Professor Dr Robert Milne. The company said 16 patients received a subcutaneous, bioabsorbable, controlled release implant of CUV1647, with no serious adverse events observed or reported. Clinuvel; said the pharmacokinetic studies measuring plasma level of the active ingredient and pharmacodynamic effects or melanin activation of the skin were part of its ongoing development program for CUV1647. The results were consistent with those seen in phase II clinical studies. The company aims to file for registration of CUV1647 in 2009. The CUV007 study was a phase I pharmacokinetic and melanogenic study of a 10mg formulation of CUV1647 implants. Previous implants have used 16mg and 20mg doses. The study showed that the 10mg CUV1647 implant was safe and tolerable. Administration of the implant resulted in detectable CUV1647 levels in plasma from which the pharmacokinetic profile was determined. Pharmacodynamic analysis showed the 10mg implant had an affect on melanin expression at most anatomical sites, with melanin density increasing above baseline following treatment administration. Clinuvel said there were no significant findings in any of the safety parameters monitored. The CUV009 study was a phase I pharmacokinetic study of two doses 28 days apart. The company said it was the first continuous dosing study. Pharmacokinetics showed there was no significant difference in blood levels between the first (Day 0) 16mg implant and the second (Day 28) 16mg implant. Pharmacodynamics showed changes in melanin density over time were significant for all anatomical sites measured. There were no significant findings in any of the safety parameters monitored. The superimposability of first and second dose profiles suggested there was no accumulation of CUV1647 and no effect of the first dose on the second dose pharmacokinetics (blood levels). The 16mg implants did have a significant effect on skin melanin expression over time with melanin density values increasing above baseline at the anatomical sites analysed following treatment administration. Clinuvel said the two studies built on its previous pharmacokinetic and pharmacodynamic study, CUV006 in 2007, and confirmed the safety record of the drug to date. Clinuvel chief executive officer Dr Philippe Wolgen said the significance of the results together with the study conducted in 2007 “will serve to aid our chances to obtain regulatory approval for CUV1647”. “Our challenge is to optimize the effective pharmacological window of CUV1647 while increasing the confidence we have in the biological safety of our drug,” Dr Wolgen said. “Two findings are seen from these studies,” Dr Wolgen said. “Whereas until recently, Clinuvel has always administered the implant formulation every 60 days, today’s clinical study results demonstrate that CUV1647 may be administered safely when the dose interval is reduced to every 28 days instead, that is without increasing and exceeding maximum human plasma ( blood) levels,” he said. “By varying and reducing the dose interval, we have been able to demonstrate the tolerability of our drug CUV1647 beyond the clinical need,” Dr Wolgen said. Clinuvel was up 2.5 cents or 6.17 percent to 43 cents.

ATCOR A 4.5 year study says that central pulse pressure is a better predictor of cardiovascular events than conventional blood pressure measurements and classic risk factors. The study, undertaken on behalf of the Aortic Blood Pressure and Survival Study Group, and published in the journal Hypertension was conducted in 1,110 consecutive patients undergoing coronary angiography. Entitled ‘Pulsatile but Not Steady Component of Blood Pressure Predicts Cardiovascular Events in Coronary Patients’ by Piotr Jankowski and colleagues from the Department of Cardiology and Hypertension at Jagiellonian University Medical Collegein Kraków, Poland (Hypertension 2008; 51, pp848-855) said central pulsatility was the most powerful predictor of the primary end point of cardiovascular death or myocardial infarction or stroke or cardiac arrest or heart transplantation or myocardial revascularization. Central pulse pressure was also independently related to the primary end point, the authors said in the abstract at: http://hyper.ahajournals.org/cgi/content/abstract/51/4/848. They said central mean blood pressure and peripheral blood pressure parameters were not independently related to the primary end point risk. Central pulsatility was also related to risk of cardiovascular death or myocardial infarction or stroke. “The pulsatile component of [blood pressure] was the most important factor related to the cardiovascular risk in coronary patients. It is more closely associated with cardiovascular risk than steady component of blood pressure,” the abstract said. Atcor said the study’s authors pointed to the consistency of their results with large population studies such as the CAFE and Strong Heart Studies which used Atcor’s Sphygmocor noninvasive central blood pressure assessment technology. Atcor said the independent clinical studies were “the key to expanding the adoption of Sphygmocor technology by clinicians”. Atcor said the studies provided support for its ongoing US reimbursement efforts. Atcor chief executive officer Duncan Ross said the evidence “continues to build in the scientific literature that central pressure assessment is a superior method of assessing cardiovascular risk “. “This new study reinforces the evidence that assessing central blood pressure is a superior way of identifying patients at cardiovascular risk,” Mr Ross said. Atcor climbed 0.7 cents or 8.43 percent to nine cents.

SAFETY MEDICAL Safety Medical Products says it has been chosen as the preferred supplier of 1ml retractable syringes to Mental Health Services in South Australia. The 1ml Securetouch will be phased in to replace the 1ml safety and standard syringes being used across the eight hospitals and centers that operate under the Mental Health Services umbrella. Department leaders have also expressed an interest to implement the 3ml and 5 ml versions of the Securetouch when they become available. Access to further markets will be assisted by this development, particularly in the company’s push to supply into the Federal Government Clean Needle Program. Safety Medical climbed 0.5 cents or 3.33 percent to 15.5 cents.

VIRALYTICS Viralytics has been granted a US patent for the use of its family of four Coxsackie viruses for the treatment of all cancers bearing expression of the ICAM-1 molecule. Viralytics said numerous cancers had elevated levels of ICAM-1 on their cell surfaces and the presence of the molecule allowed its family of viruses to lock onto the surface of cancer cells, infect and destroy them. The patent is entitled ‘Methods for treating malignancies expressing ICAM-1 using Coxsackie A group viruses’. Similar patents addressing the anti-cancer activity of the company’s Coxsackie A group viruses have already granted in Australia and New Zealand. The patenting process for these viruses and the company’s other oncolytic virus technology, Evatak (Echovirus type 1) is continuing in other markets. Viralytics director and the inventor of the Coxsackie virus technology Prof Darren Shafren said the issue of the patent was “a significant milestone for the company as it covers the company’s core oncolytic virus technology”. “As the US represents approximately 40 percent of the world market for cancer treatments the granting of a patent in this market is a major step towards the successful commercialization of an anti-cancer product”. The company said the granting of the core patent added “significant value to the company’s intellectual property portfolio”. Viralytics said the scope of the patent covered the use of the company’s lead product, Cavatak, which is in two phase I monotherapy trials in late stage melanoma, breast and prostate cancer patients, and three additional strains of Coxsackie A group viruses in preclinical development by Viralytics. The patent provides an exclusive use of our family of Coxsackie A group viruses for the treatment of cancers until 2022 with up to a five year extension to 2027 potentially available under US legislation. Viralytics climbed 1.4 cents or 21.21 percent to eight cents with 3.8 million shares traded.

APOLLO LIFE SCIENCES Apollo Life Sciences has engaged Deloitte Touche Tohmatsu to advise on the company’s restructure. Apollo said it had been approached by a number of domestic and international parties interested in the sale of the over- the-counter and skin care and research proteins business. The company said Deloitte Touche Tohmatsu would advise on the restructure and the strategic sale of business assets. Apollo said it wanted “to ensure that structured competitive processes are in place in relation to sale transactions”. The company said its core intellectual property and therapeutic candidates, including the oral and topical delivery technologies for large water soluble molecules such as proteins and antibodies were not actively being considered for sale at this point. Shareholder approvals will be sought as required Apollo wishes to advise that it will consider all bona fide offers. Apollo is in a voluntary suspension and last traded at four cents.

GENETIC TECHNOLOGIES Genetic Technologies has made two executive appointments “to accelerate the company’s transformation and implementation of its strategic agenda”. Ross Barrow has been appointed chief operating officer and Catherine Barclay has been appointed people and customer service manager. Mr Barrow’s previous role was director of technology and Melbourne operations for Leica Biosystems, a subsidiary of the US-based Danaher Corp. Mr Barrow was previously the chief operating officer of Vision Biosystems and prior to that spent 11 years with BHP in a variety of roles managing research and development and technology development programs. Ms Barclay was previously the human resources operations manager with AXA APH. She has more than eight years human resources experience and 10 years experience managing customer service teams in the financial services sector. Genetic Technologies’ chief executive officer Michael Ohanessian said the appointments were “a critical step in the development and implementation of the company’s strategic goals”. Genetic Technologies said chief scientific officer Dr Gary Cobon has decided to leave the company. Genetic Technologies was untraded at 10 cents. ARANA Sun Hung Kai Investment Services and associates have become substantial shareholders in Arana with a holding of 11,854,898 shares or 5.0449 percent. Sun Hung Kai is Hong Kong based and the associates are Honest Opportunity Limited and Future Rise Investments. Arana was up two cents or 2.13 percent to 96 cents.

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